Regulatory Authority
Regulatory Authority
Scope of Assessment
Regulatory Fees
Ethics Committee
Ethics Committee
Scope of Review
Ethics Committee Fees
Authorizing Body
Clinical Trial Lifecycle
Submission Process
Submission Content
Timeline of Review
Trial Initiation
Safety Reporting
Progress Reporting
Sponsorship
Definition of Sponsor
Trial Authorization
Insurance
Compensation
Quality, Data & Records Management
Site/Investigator Selection
Informed Consent
Documentation Requirements
Required Elements
Compensation Disclosure
Participant Rights
Special Circumstances/Emergencies
Vulnerable Populations
Children/Minors
Pregnant Women, Fetuses & Neonates
Prisoners
Mentally Impaired
Investigational Products
Definition of Investigational Product
Manufacturing & Import
IMP/IND Quality Requirements
Labeling & Packaging
Product Management
Specimens
Definition of Specimen
Import & Export
Consent for Specimens

NOTE: Peru’s new Clinical Trials Regulation, Supreme Decree No. 021-2017-SA, was published on June 30, 2017, in The Peruvian Official Daily.  (Unofficial Google Translation of Supreme Decree No. 021-2017-SA)

 

Per the new regulation, Peru has lifted the suspension on authorizing new clinical trials with children or indigenous populations.

 

This regulation repeals Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru, Supreme Decree No. 006-2007-SA: Modification of Regulation on Clinical Trials in Peru, and Supreme Decree No. 020-2015-SA. 

 

The ClinRegs team will carefully review the new regulation and update the Peru page.

 

Peru
QUICK FACTS
Clinical trial application languageSpanish
Parallel regulatory and ethical review permittedNo
Clinical trial registration requiredYes
In-country sponsor presence/representation requiredYes
Age of minorsUnspecified
Specimens export allowedUnspecified
Regulatory Authority > Regulatory Authority
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SUMMARY

Overview
As per ResolutionNo089-2003-SA/DM, DecreeNo 017-2006-SA, RJ No 239-2012-OPE/INS, and Additional Resource (A), Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) is the regulatory authority responsible for clinical trial approvals, oversight, and inspections. The INS grants permission for clinical trials to be conducted in Peru in accordance with ResolutionNo089-2003-SA/DM, DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, and RJ No 239-2012-OPE/INS.

As indicated in DecreeNo 001-2003-SA and Additional Resources (B), (D), (E), and (F), the INS is an executive agency within the Ministry of Health of Peru (Ministerio de Salud del Perú (MINSA)), and was granted authority to approve clinical trials by the MINSA in 2004. The INS’s General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnoligica (OGITT)) carries out the INS’s mandate to review, record, and authorize clinical trials, to regulate research in Peru, and to ensure the implementation of international ethical guidelines and good clinical practice (GCP) in the conduct of clinical trials.

The OGITT is also in charge of the Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)), the Registry of Institutional Research Ethics Committees, the Registry of Research Sites, and the Registry of Contract Research Organizations. In addition, the OGITT implements the INS’s objectives to promote, develop, and disseminate scientific and technological research, propose policies and standards, and provide health services to the Peruvian population.

Contact Information
Instituto Nacional de Salud
Cápac Yupanqui 1400
Jesus María
Lima 11
Perú

Phone: 511 748 1111
Fax: Not Available
General Email: postmaster@ins.gob.pe

Application Submissions Contact Information
Instituto Nacional de Salud
Oficina General de Investigacion Y Transferencia Tecnologica
Cápac Yupanqui 1400
Jesus María
Lima 11
Perú

Clinical Research Office Phone: 511 617 6200 Ext. 2191
Fax: Not Available
Clinical Research Office Email: consultaensayos@ins.gob.pe

ADDITIONAL RESOURCES

(A) (Website) Background on Clinical Trials Regulation (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

(B) (Website) About INS (Spanish/Español) (Current as of October 18, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

(C) (Presentation) Good Clinical Practice and Regulatory Aspects (April 2011)
Espiritu, Nora
Drug Information Association, Washington, DC

(D) (Website) Peru – National Institute of Health (INS) (Current as of March 4, 2014)
International Association of National Public Health Institutes (IANPHI), Atlanta, GA

(E) (Website) General Office for Research and Technology Transfer (OGITT) - Functions (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

(F) (Website) REPEC - Information for Citizens - About Clinical Trials in Peru (English and Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

(G) (Website) Peruvian Clinical Trials Registry (REPEC) (Spanish/Español) (Current as of March 13, 2014)
National Institute of Health, Ministry of Health, Republic of Peru

(H) (Website) INS Institutional Phone Directory (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

REQUIREMENTS

(1) (Regulation) Ministry Resolution No. 089-2003-SA/DM: Provides that Administrative Process Established by the Ministry  Text of Administrative Procedures (TUPAs) is the Jurisdiction of the National Institute of Health (ResolutionNo089-2003-SA/DM – Spanish/Español) (January 24, 2003)
Ministry of Health, Republic of Peru

Relevant Section: Article 1
 
(2) (Regulation) Supreme Decree No. 001-2003-SA: Approves the Regulation of Organization and Functions of the National Institute of Health (DecreeNo 001-2003-SA – Spanish/Español) (January 9, 2003)
Ministry of Health, Republic of Peru

Relevant Sections: Title I and Title II (Chapters I and III)

(3) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA – Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

(4) (Regulation) Supreme Decree No. 006-2007-SA: Modification of Regulation on Clinical Trials in Peru (DecreeNo 006-2007-SA – Spanish/Español) (June 8, 2007)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Articles 39, 57, and 66

(5) (Regulation) Departmental Resolution No. 239-2012-J-OPE/INS (RJ No 239-2012-OPE/INS – Spanish/Español) (July 20, 2012)
Health Sector, National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Introduction and Chapter III (1)

(6) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (INS CTManual – Spanish/Español) (December 2012)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: Chapter III (Section 3.1)

(7) (Regulation) Supreme Decree No. 020-2015-SA (Decree No 020-2015-SA - Spanish/Español) (June 18, 2015)
Ministry of Health, Republic of Peru

Regulatory Authority > Scope of Assessment
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SUMMARY

Overview
In accordance with ResolutionNo089-2003-SA/DM, DecreeNo 017-2006-SA, and the INS CTManual, Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) is responsible for reviewing, evaluating, and approving applications for clinical trials using registered or unregistered investigational products (IPs). As per DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, DecreeNo 016-2011-SA, and the INS CTManual, the scope of the INS’s assessment includes Phases I through IV clinical trials for pharmaceuticals including medicines, herbal medicines and other complementary products, dietetic products and sweeteners, biological products, and compounded (galenic) products.

As specified in DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, RJ No 239-2012-OPE/INS, the INS CTManual, and Additional Resources (A) and (B), the INS’s review and approval of a clinical trial application is dependent upon obtaining proof of ethics committee (EC) approval. According to DecreeNo 017-2006-SA and the INS CTManual, the INS and EC reviews may not be conducted in parallel. EC approval of the research protocol and informed consent form must be submitted as part of the clinical trial application dossier in order for the INS to conduct its review.

Clinical Trial Review Process
As per RJ No 239-2012-OPE/INS, the INS CTManual, and Additional Resources (A), (B), and (E), the sponsor or his/her contract research organization (CRO) must submit the application electronically using the Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)), at which time a registration code is assigned to the application.

Upon receipt of the application package, the INS’s Document Processing Area reviews the application for completeness. If a document is missing, the sponsor or his/her CRO is given two (2) days to provide the required documentation. A completed application is assigned a number in the SITRADOC (INS Document Processing System (Sistema de tramite documentario del INS)), and forwarded to the INS’s General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnoligica (OGITT)). The OGITT General Director reviews the application and includes notes which are updated in the SITRADOC. The application is then activated in the INS’s Clinical Trials Registry System (REPEC). The OGITT General Director subsequently forwards the application to the Director of the Executive Office of Research (Oficina Ejecutiva de Investigaction (OEI)), who, in coordination with a Clinical Trials System Administrator, assigns a technical reviewer to review the application.

The Investigator’s Brochure and the protocol is also simultaneously reviewed by the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID)) in order to obtain a safety evaluation of the investigational product (IP).

The OGITT technical reviewer evaluates the protocol, the informed consent form, and any previously written DIGEMID IP safety reports, if applicable, and prepares a draft technical report that is submitted to the OEI. The OEI Director reviews the application dossier and the draft technical report, and signs off on the application. The final review is conducted by the OGITT General Director to ensure the application is compliant, and then issues his/her approval.

The INS CTManual specifies that the approval of a new application is valid for one (1) year. For all approved studies whose duration is greater than one (1) year, the sponsor or his/her CRO is required to request an authorization renewal at least one (1) month prior to the authorization’s expiration.

(See the Clinical Trial Lifecycle topic, Submission Process, Submission Content, and Timeline of Review subtopics for detailed submission requirements.)

ADDITIONAL RESOURCES

(A) (Website) Background on Clinical Trials Regulation (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: History of Processes Involved in Clinical Trial Legislation in Peru

(B) (Website) Information for Investigators (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: 1. Clinical Trial Authorization – Requirements

(C) (Website) Clinical Trials in Peru (English and Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

(D) (Website) General Office for Research and Technology Transfer (OGITT) - Functions (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

(E) (Website) Peruvian Clinical Trials Registry (REPEC) (Spanish/Español) (Current as of March 13, 2014)
National Institute of Health, Ministry of Health, Republic of Peru

(F) (Website) General Directorate of Medicines, Supplies and Drugs (DIGEMID) (Spanish/Español) (Current as of March 13, 2014)
Ministry of Health, Republic of Peru

REQUIREMENTS

(1) (Regulation) Ministry Resolution No. 089-2003-SA/DM: Provides that Administrative Process Established by the Ministry Text of Administrative Procedures (TUPAs) is the Jurisdiction of the National Institute of Health (ResolutionNo089-2003-SA/DM - Spanish/Español) (January 24, 2003)
Ministry of Health, Republic of Peru

Relevant Section: Article 1

(2) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

(3) (Regulation) Supreme Decree No. 006-2007-SA: Modification of Regulation on Clinical Trials in Peru (DecreeNo 006-2007-SA - Spanish/Español) (June 8, 2007)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Articles 39, 57, and 66

(4) (Regulation) Supreme Decree No. 016-2011-SA: Regulation for the Registry, Monitoring of Medical Pharmaceuticals, Devices and Sanitary Products (DecreeNo 016-2011-SA - Spanish/Español) (July 27, 2011)
Ministry of Health, Republic of Peru

Relevant Sections: Title I (Article 2) and Title II (Chapters I and V)

(5) (Regulation) Departmental Resolution No. 239-2012-J-OPE/INS (RJ No 239-2012-OPE/INS - Spanish/Español) (July 20, 2012)
Health Sector, National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Introduction and Chapter III (1)

(6) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (INS CTManual - Spanish/Español) (December 2012)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Chapter III (section 3.1) and Annex 1

Regulatory Authority > Regulatory Fees
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SUMMARY

Overview
As per Additional Resource (A), the sponsor or his/her contract research organization (CRO) is responsible for paying a fee to the National Institute of Health of Peru (Instituto Nacional de Salud (INS)) to submit a clinical trial application for authorization.

See Additional Resource (A) for detailed information on INS clinical trial-related costs.

Instructions for Payment of Clinical Trial Application Fee
Payment is usually made by check or cash, and submitted with the printed application.

ADDITIONAL RESOURCES

(A) (Website) Information for Investigators (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: 1. Clinical Trial Authorization

REQUIREMENTS

No applicable regulatory requirements

Ethics Committee > Ethics Committee
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SUMMARY

Overview
As set forth in DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, RJ No 239-2012-OPE/INS, the INS CTManual, and Additional Resources (A), (B), and (C), Peru requires clinical trial approval from an institutional level ethics committee (EC) that is registered with the National Institute of Health (Instituto Nacional de Salud (INS)). There are no stated requirements regarding which EC the sponsor should choose to conduct the clinical protocol review.

See the INS CTManual and Additional Resource (C) for detailed instructions, and the application form required to register an institutional EC. As per Additional Resource (D), the Executive Office of Research within the INS’s General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnoligica (OGITT)) is responsible for organizing and maintaining the registration system for clinical trials, institutional ECs, research sites, and contract research organizations (CROs).

Peru’s Institutional Research Ethics Committee of the National Institute of Health (El Comité Institucional de Etica en Investigación del Instituto Nacional de Salud (CIEI-INS)) does not approve clinical trials.

Institutional EC Composition
As delineated in DecreeNo 017-2006-SA, institutional ECs should consist of at least seven (7) members represented by a multidisciplinary group of health professionals and community members. The majority of the members must have competence and experience in the methodological, ethical, and legal aspects of research, pharmacology, and medical care. At least two (2) members must have training in bioethics, and at least one (1) should be a community representative.

DecreeNo 006-2007-SA, which amends DecreeNo 017-2006-SA, specifies that there must be at least five (5) core EC members, with both genders represented. The membership should include at least one (1) member from the research institution, at least one (1) member who is unaffiliated with the institution, at least one (1) member from the community, and alternate members whose number will be determined by the individual EC. In addition, all members must have a certificate of basic training in research ethics, and one of its members must be trained in bioethics. Member responsibilities, the duration of the membership, and the replacement procedures are defined in each EC’s internal regulations and procedures manual.

Terms of Reference, Review Procedures, and Meeting Schedule for Institutional ECs
DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, and the INS ECManual state that the procedural requirements for the operation of institutional ECs are minimal. Each EC must be registered with the INS, and this registration must be renewed every two (2) years. ECs must also prepare a Rules and Procedures Manual that is approved by the research institution; seek specialist(s) advice on diseases or methodologies outside the EC’s expertise; ensure that alternate committee members have been selected; and determine member composition, meeting frequency, and quorum requirements.

ADDITIONAL RESOURCES

(A) (Website) Norms (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

(B) (Website) Requirements for Project Evaluation (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

(C) (Website) Registration of Institutional Research Ethics Committee (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

(D) (Website) General Office for Research and Technology Transfer (OGITT) - Functions (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

(E) (Website) Schedule and Members (CIEI-INS) (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

(F) (Presentation) Clinical Trials Situation In Peru (Spanish/Español) (August 20, 2013)
General Office for Research and Technology Transfer (OGITT), National Institute of Health, Ministry of Health, Republic of Peru

(G) (Website) Search of Registered Institutional Ethics Committees (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

(H) (Presentation) Good Clinical Practice and Regulatory Aspects (April 2011)
Espiritu, Nora
Drug Information Association, Washington, DC

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

(2) (Regulation) Supreme Decree No. 006-2007-SA: Modification of Regulation on Clinical Trials in Peru (DecreeNo 006-2007-SA - Spanish/Español) (June 8, 2007)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Articles 39, 57, 59, 60, and 66 (c)

(3) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (INS CTManual - Spanish/Español) (December 2012)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Chapter III (Section 3.2) and Annex 17 (Application for Registration of Institutional Research Ethics Committee)

(4) (Guidance) Model Manual of Procedures for Institutional Ethics Committees on Research in Peru (INS ECManual - Spanish/Español) (January 2013)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Objectives, Operating Definitions, Chapter I, Chapter II, Annex A, and Annex B

Ethics Committee > Scope of Review
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SUMMARY

Overview
According to DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, the INS ECManual, and Additional Resources (A) and (B), the primary scope of information assessed by institutional ethics committees (ECs) relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial.

As per the INS ECManual, the ECs must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable. (See Informed Consent topic, and the subtopics of Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses & Neonates; and Mentally Impaired for additional information about these populations).

DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, and the INS ECManual, also state that National Institute of Health (Instituto Nacional de Salud (INS))-registered institutional ECs are responsible for ensuring an independent, timely, and competent review of all ethical aspects of the clinical trial protocol. They must act in the interests of the potential research participants and the communities involved by evaluating the possible risks and expected benefits to participants; confirming the suitability of the investigator(s), facilities, and methods; and verifying the adequacy of confidentiality and privacy safeguards. See the INS ECManual for detailed ethical review guidelines.

Role in Clinical Trial Approval Process
As per DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, RJ No 239-2012-OPE/INS, the INS CTManual, the INS ECManual, and Additional Resource (D), an INS-registered EC must approve the clinical trial protocol and informed consent form prior to the sponsor or his/her contract research organization (CRO) submitting the clinical trial application to the INS. The INS and EC reviews may not be conducted in parallel.

The INS ECManual specifies that the approval of a new application is valid for one year. All approved studies running for more than one year are subject to continuing annual review by the respective EC. An application for continuing EC review must be made one (1) month prior to the expiration of the previous approval. As per the INS ECManual, the EC typically reviews and approves submitted applications between 20 and 40 days depending on the project’s complexity.

(See the Clinical Trial Lifecycle topic, Submission Process and Timeline of Review subtopics for detailed submission process and timeline details.)

ADDITIONAL RESOURCES

(A) (Website) Norms (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

(B) (Website) Requirements for Project Evaluation (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

(C) (Website) Background on Clinical Trials Regulation (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: History of Processes Involved in Clinical Trial Legislation in Peru

(D) (Website) Information for Investigators (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

(2) (Regulation) Supreme Decree No. 006-2007-SA: Modification of Regulation on Clinical Trials in Peru (DecreeNo 006-2007-SA - Spanish/Español) (June 8, 2007)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Articles 57, 59, 60, and 66 (c)

(3) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (INS CTManual - Spanish/Español) (December 2012)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Chapter III (section 3.1) and Annex 1

(4) (Guidance) Model Manual of Procedures for Institutional Ethics Committees on Research in Peru (INS ECManual - Spanish/Español) (January 2013)
National Institute of Health of Peru, Ministry of Health of Peru, Republic of Peru

Relevant Sections: Objectives, Operating Definitions, Chapter I, Chapter II, Annex A, and Annex B

Ethics Committee > Ethics Committee Fees
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SUMMARY

Overview
As set forth in DecreeNo 017-2006-SA and DecreeNo 006-2007-SA, institutional research ethics committees are not for profit and may only charge a fee to cover their operating expenses.

ADDITIONAL RESOURCES

(A) (Website) Information for Investigators (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

(2) (Regulation) Supreme Decree No. 006-2007-SA: Modification of Regulation on Clinical Trials in Peru  (DecreeNo 006-2007-SA - Spanish/Español) (June 8, 2007)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Articles 57, 59, 60, and 66 (c)

Ethics Committee > Authorizing Body
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SUMMARY

Overview
As set forth in DecreeNo 001-2003-SA, Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) is the central body responsible for the oversight, promotion, and coordination of research. The INS is a decentralized public agency of the Ministry of Health of Peru (Ministerio de Salud del Perú (MINSA)).

Registration, Auditing, and Accreditation
As per the INS CTManual and Additional Resources (A) and (B), the Executive Office of Research within the INS’s General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnoligica (OGITT)) is responsible for registering institutional ethics committees (ECs). The INS CTManual provides detailed information on the inspections that the INS-registered ECs may be subject to before, during, and after the registration of an EC. No information is currently available on an accreditation process for INS-registered ECs.

ADDITIONAL RESOURCES

(A) (Website) General Office for Research and Technology Transfer (OGITT) - Functions (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru
 (English)

(B) (Website) Registration of Institutional Research Ethics Committee (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 001-2003-SA: Approves the Regulation of Organization and Functions of the National Institute of Health (DecreeNo 001-2003-SA - Spanish/Español) (January 9, 2003)
Ministry of Health, Republic of Peru

Relevant Section: Title I, Title II (Chapters I and III)

(2) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (INS CTManual - Spanish/Español) (December 2012)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Chapter 3 (Section 3.4) and Annex 20 (Inspection Form for ECs)

Clinical Trial Lifecycle > Submission Process
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SUMMARY

Overview
In accordance with DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, RJ No 239-2012-OPE/INS, the INS CTManual, and Additional Resources (A) and (B), Peru requires the sponsor or his/her contract research organization (CRO) to obtain clinical trial authorization from Peru’s National Institute of Health (INS) and ensure his/her principal investigators (PIs) obtain ethics committee (EC) approval from an INS-registered EC. DecreeNo 017-2006-SA and DecreeNo 006-2007-SA also state that if the sponsor is not based in Peru, it is a statutory requirement for the sponsor to appoint a legal representative in the country for the trial’s duration.

According to DecreeNo 017-2006-SA, and the INS CTManual, the INS and EC reviews may not be conducted in parallel. The INS-registered EC must first approve the research protocol and informed consent form (ICF), and the sponsor or his/her CRO must submit this information as part of the application dossier in order for the INS to conduct its review. (See Submission Content subtopic for detailed submission requirements).

Delivery Address for Clinical Trial Application
Instituto Nacional de Salud
Oficina General de Investigacion Y Transferencia Tecnologica
Cápac Yupanqui 1400
Jesus María
Lima 11
Perú

Clinical Research Office Phone: 511 617 6200 Ext. 2191
Fax: Not Available
Clinical Research Office Email: consultaensayos@ins.gob.pe

Assembly and Number of Copies
Based on information provided in RJ No 239-2012-OPE/INS, the INS CTManual, and Additional Resources (B) and (C), the sponsor or his/her CRO must submit a request for clinical trial authorization electronically using the Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)), at which time a registration code is assigned to the application. As per Additional Resource (B), one copy of the application must be submitted to the INS in an arch lever file (spring file folder) with the documents paginated and labeled using dividers, and ordered as indicated in the requirements listed in DecreeNo 017-2006-SA, RJ No 239-2012-OPE/INS, INS CTManual, and Additional Resource (B). The application and related materials must be sent to the INS within seven (7) days of receiving the registration code. If the seven (7) day timeframe is exceeded, the application will be discarded, and another application must be submitted electronically to obtain a new registration code and initiate the process again.

Clinical Trial Application Language Requirements
As delineated in the INS CTManual, the clinical trial application and accompanying material must be provided in Spanish. Any document not in Spanish must be submitted with a corresponding translation.

ADDITIONAL RESOURCES

(A) (Website) Background on Clinical Trials Regulation (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: History of Processes Involved in Clinical Trial Legislation in Peru

(B) (Website) Information for Investigators (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: Requirement 1

(C) (Website) Peruvian Clinical Trials Registry (REPEC) (Spanish/Español) (Current as of March 13, 2014)
National Institute of Health, Ministry of Health, Republic of Peru

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

(2) (Regulation) Supreme Decree No. 006-2007-SA: Modification of Regulation on Clinical Trials in Peru  (DecreeNo 006-2007-SA - Spanish/Español) (June 8, 2007)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Articles 39, 57, and 66

(3) (Regulation) Departmental Resolution No. 239-2012-J-OPE/INS (RJ No 239-2012-OPE/INS - Spanish/Español) (July 20, 2012)
Health Sector, National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: Chapter III (1)

(4) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (INS CTManual - Spanish/Español) (December 2012)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Chapter III (Sections 3.1 and 3.2), Annex 1 (Application for Clinical Trial Authorization), and Annex 17 (Application for Registration of Institutional Research Ethics Committee)

Clinical Trial Lifecycle > Submission Content
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SUMMARY

Overview
As set forth in DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, RJ No 239-2012-OPE/INS, the INS CTManual, and Additional Resource (B), Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) requires the sponsor or his/her contract research organization (CRO) to apply for clinical trial authorization, and the principal investigator (PI) to apply for approval from an INS-registered ethics committee (EC) to conduct a drug-related clinical trial.

INS Requirements
As specified in DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, RJ No 239-2012-OPE/INS, the INS CTManual, and Additional Resources (B) and (C), a clinical trial application submission must include the following documents:

  • Application for clinical trial authorization
  • Approval(s) for institution(s) where research will be conducted
  • Ethics committee (EC) approval of the research protocol and informed consent form (ICF)
  • Research protocol in Spanish, and in the original language, if different from Spanish (see  Annex 5 in the INS CTManual)
  • ICF
  • Investigator’s Brochure (IB) updated version in Spanish, and in the original language, if different from Spanish (See Annex 6 in Additional Resource (A))
  • Affidavit stating no conflict of financial interest signed by the sponsor/CRO and the PI (see Annex 7 in  the INS CTManual)
  • Clinical trial budget (see Annex 8 in the INS CTManual)
  • Affidavit on compensation for participants signed by the sponsor/CRO and PI (covers budget and expenses for any trial-related injuries) (See Annex 9 in the INS CTManual)
  • Copy of current insurance policy
  • List of clinical trial supplies (See Annex 10 in the INS CTManual)
  • PI and co-investigator(s) curriculum vitaes (CVs)
  • Copy of the site registration form(s) as an authorized research center for clinical trials
  • Payment receipt for research site registration; in the case of multicenter trials, receipts must be provided to demonstrate each research site has made separate payment

Refer to DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, RJ No 239-2012-OPE/INS, the INS CTManual, and Additional Resources (B) and (C) for detailed submission information. Also see the Submission Process subtopic for additional submission requirements.

Institutional EC Requirements
As per the INS ECManual, DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, and Additional Resource (C), institutional ECs generally require PIs to submit the following documentation for ethics approval:

  • Letter from the PI to the EC Chairman
  • Two (2) copies of the Basic Format Application (see Annex A in the INS ECManual)
  • Two (2) copies of the research protocol (in printed and electronic format with date and version number)
  • Two (2) copies of the ICF (in printed and electronic format with date and version number)
  • One (1) copy of PI and co-investigator(s) CV(s)
  • One (1) copy of the PI statement
  • One (1) copy of the Declaration of the PI and research center director/research institution head
  • One (1) copy of the Declaration of the PI and co-investigators
  • One (1) copy of the Declaration of financial details and potential conflicts of interest
  • One (1) copy of the Certainty of Approval of the Protocol, by an institutional research committee to ensure scientific validity
  • One (1) copy of signed Commitments of the Investigator Form
  • List of requirements for submission of projects
  • One (1) copy of the Form for the Use of Cryopreserved Biological Samples in the INS bank or other institutions, if applicable
  • Payment receipt for the Institutional Research Ethics Committee of the National Institute of Health (El Comité Institucional de Etica en Investigación del Instituto Nacional de Salud (CIEI-INS)) draft assessment
  • Two (2) copies of the IB
  • One (1) copy of sponsor’s insurance policy (original and, if applicable, a version with a certified Spanish translation)
  • One (1) copy documenting the PI’s training in good clinical research ethics

Clinical Protocol
According to DecreeNo 017-2006-SA and the INS CTManual, the clinical protocol should contain the following elements:

  • Protocol code
  • Sponsor or CRO and PI/co-investigator(s) names and contact information
  • Protocol title and summary
  • Investigational Product description (See Investigational Products topic for detailed coverage of this subject)
  • Form, dosage, route, method, and frequency of administration; treatment period
  • Disease/injury problem and background research
  • Justification of clinical trial
  • Objectives
  • Methodology (including trial design, random selection method, and blinding level)
  • Eligibility criteria and monitoring (including participant selection/withdrawal)
  • Participant treatment
  • Description of test development methods and evaluation of response (quality control)
  • Adverse event reporting requirements (See Clinical Trial Lifecycle topic, Safety Reporting subtopic for additional information)
  • Ethical considerations
  • Researcher(s) responsibilities and liabilities
  • Statistics and methods to track trial data
  • Timetable specifying study phases and runtimes
  • References and annexes

For complete protocol requirements, refer to DecreeNo 017-2006-SA and the INS CTManual.

ADDITIONAL RESOURCES

(A) (Website) Background on Clinical Trials Regulation (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: History of Processes Involved in Clinical Trial Legislation in Peru

(B) (Website) Information for Investigators (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: Requirement 1

(C) (Website) Requirements for Project Evaluation (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

(D) (Website) Registration of Institutional Research Ethics Committee (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

(2) (Regulation) Supreme Decree No. 006-2007-SA: Modification of Regulation on Clinical Trials in Peru (DecreeNo 006-2007-SA - Spanish/Español) (June 8, 2007)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Articles 39, 57, and 66

(3) (Regulation) Departmental Resolution No. 239-2012-J-OPE/INS (RJ No 239-2012-OPE/INS - Spanish/Español) (July 20, 2012)
Health Sector, National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: Chapter III (1)

(4) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (INS CTManual - Spanish/Español) (December 2012)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Chapter III (Sections 3.1 and 3.2), Annex 1 (Application for Clinical Trial Authorization), Annex 5 (Research Protocols Guide), Annex 6 (Investigator’s Brochure Guide), Annex 7 (Affidavit of No Financial Conflict of Interest in the Performance of Clinical Trials), Annex 8 (Clinical Trial Budget), Annex 10 (List of Products & Supplies Used in the Clinical Trial), and Annex 17 (Application for Registration of Institutional Research Ethics Committee)

(5) (Guidance) Model Manual of Procedures for Institutional Ethics Committees on Research in Peru (INS ECManual - Spanish/Español) (January 2013)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Chapter II, Annex A, Annex B, Annex C, and Annex D

Clinical Trial Lifecycle > Timeline of Review
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SUMMARY

Overview
Based on DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, RJ No 239-2012-OPE/INS, the INS CTManual, and Additional Resources (A) and (B), the National Institute of Health (Instituto Nacional de Salud (INS))’s review and approval of an application to conduct a clinical trial is dependent upon obtaining ethics committee (EC) approval from an INS-registered EC. DecreeNo 017-2006-SA and the INS CTManual state that the INS and EC reviews may not be conducted in parallel.

INS Approval
Clinical Trial Application Submission
As per DecreeNo 006-2007-SA, RJ No 239-2012-OPE/INS, and the INS CTManual, the INS review and approval process for a clinical trial application takes 40 working days. Additionally, in clinical research using genetic therapy, somatic cell therapy and all products derived from genetically modified organisms and in controversial situations that imply calling a technical commission, the approval timeframe will be 60 working days. For specific information on pre-submission registration requirements, see Clinical Trial Lifecycle topic, Submission Process subtopic.

Upon receipt of the application package, the INS’s Document Processing Area reviews the application for completeness. If a document is missing, the sponsor or his/her contract research organization (CRO) is given two (2) days to provide the required documentation. A completed application is assigned a number in the SITRADOC (INS Document Processing System (Sistema de tramite documentario del INS)) and forwarded to the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnoligica (OGITT)). The OGITT General Director reviews the application and includes notes which are updated in the SITRADOC. The application is then activated in the INS’s Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)). The OGITT General Director subsequently forwards the application to the Director of the Executive Office of Research (Oficina Ejecutiva de Investigaction (OEI)), who, in coordination with a Clinical Trials System Administrator, assigns a technical reviewer to review the application. The REPEC staff enters the date that the technical reviewer receives the application, and tracks the application’s progress using an assigned label.

The Investigator’s Brochure (IB) and the protocol is also simultaneously forwarded to the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID)) in order to obtain a safety evaluation of the IP. DecreeNo 017-2006-SA and RJ No 239-2012-OPE/INS states that the DIGEMID must provide a technical opinion within 30 days.

The OGITT technical reviewer evaluates the protocol, the informed consent form (ICF), any previously written DIGEMID IP safety reports, if applicable, and prepares a draft technical report that is submitted to the OEI. The OEI executive director reviews the application dossier and the draft technical report, and signs off on the application if it is approved. The final review is conducted by the OGITT General Director, who reviews the application to determine whether it is compliant, and also signs off on the application once it is approved. The Clinical Trial Systems staff is responsible for entering the final approval information into the REPEC. Applicants can monitor the progress of their application in REPEC (See Additional Resource (E)).

Ethics Committee Approval
The EC review and approval process timeline will vary by institution.

ADDITIONAL RESOURCES

(A) (Website) Background on Clinical Trials Regulation (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: History of Processes Involved in Clinical Trial Legislation in Peru

(B) (Website) Information for Investigators (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: 1. Clinical Trial Authorization

(C) (Website) Clinical Trials in Peru (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

(D) (Website) General Office for Research and Technology Transfer (OGITT) - Functions (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

(E) (Website) Peruvian Clinical Trials Registry (REPEC) (Spanish/Español) (Current as of March 13, 2014)
National Institute of Health of Peru, Ministry of Health of Peru, Republic of Peru

(F) (Website) Considerations for the Procedures Related to Clinical Trials in Accordance to the Clinical Trial Regulation and Its Amendment (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

(2) (Regulation) Supreme Decree No. 006-2007-SA: Modification of Regulation on Clinical Trials in Peru (DecreeNo 006-2007-SA - Spanish/Español) (June 8, 2007)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Articles 39, 57, 66, and 69

(3) (Regulation) Departmental Resolution No. 239-2012-J-OPE/INS (RJ No 239-2012-OPE/INS - Spanish/Español) (July 20, 2012)
Health Sector, National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Chapter III (1)

(4) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (INS CTManual - Spanish/Español) (December 2012)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Chapter III (Sections 3.1 and 3.2), Annex 1 (Application for Clinical Trial Authorization), and Annex 17 (Application for Registration of Institutional Research Ethics Committee)

(5) (Guidance) Model Manual of Procedures for Institutional Ethics Committees on Research in Peru (INS ECManual - Spanish/Español) (January 2013)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Objectives, Operating Definitions, Chapter I, Chapter II, Annex A, and Annex B

Clinical Trial Lifecycle > Trial Initiation
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SUMMARY

Overview
In accordance with DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, RJ No 239-2012-OPE/INS, the INS CTManual, and Additional Resources (A) and (B), a clinical trial can only commence after the sponsor or his/her contract research organization (CRO) receives authorization from Peru’s National Institute of Health (Instituto Nacional de Salud (INS)), which is dependent on ethics committee (EC) approval from an INS-registered EC. DecreeNo 017-2006-SA and the INS CTManual states that the INS and EC reviews may not be conducted in parallel. No waiting period is required following the applicant’s receipt of these approvals.

As per DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, and DecreeNo 016-2011-SA, the sponsor or his/her CRO is required to obtain an import license for the shipment of an investigational product to be used in the trial from the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID)). (See the Investigational Products topic, Manufacturing & Import subtopic for additional information).

As stated in the DecreeNo 017-2006-SA, all investigators must possess appropriate qualifications, training, and experience. DecreeNo 017-2006-SA and DecreeNo 006-2007-SA specify that the trials should be conducted in compliance with the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs).

Clinical Trial Agreement
According to DecreeNo 017-2006-SA, before the trial begins, the sponsor or his/her CRO, a representative from the institution where the research is taking place, and the PI must sign a clinical trial agreement in which the obligations of each party are established.  Additional Resource (D), however, further states that DecreeNo 017-2006-SA does not have the force to require these parties to sign a tripartite model contract, and does not require an agreement to be attached in the application dossier. Based on this resource, the INS believes that it is incumbent upon the sponsor and his/her CRO, the research institution, and the PI to establish and formalize an agreement of their own accord.

EC Confirmation of Review and Approval
DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, RJ No 239-2012-OPE/INS, the INS CTManual, and Additional Resource (A) mandate that the sponsor or his/her CRO obtain written confirmation of EC review and approval from an INS-registered EC prior to the trial’s commencement. (See Ethics Committee topic, Scope of Review subtopic and Clinical Trial Lifecycle topic, Submission Content subtopic for additional details on the EC review process).

Peruvian Clinical Trials Register
As per RJ No 239-2012-OPE/INS, the INS CTManual, and Additional Resources (B) and (E), the sponsor or his/her CRO must register the clinical trial application electronically using the INS’s Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)), at which time, a registration code is assigned to the application.

Data Safety Monitoring Board
According to the INS CTManual, a Data Safety Monitoring Board (DSMB) or a similar body must be established to regularly assess the progress of the trial.

ADDITIONAL RESOURCES

(A) (Website) Background on Clinical Trials Regulation (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: History of Processes Involved in Clinical Trial Legislation in Peru

(B) (Website) Information for Investigators (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: Requirement 1

(C) (Website) General Directorate of Medicines, Supplies and Drugs (Spanish/Español) (Current as of March 13, 2014)
Ministry of Health, Republic of Peru

(D) (Website) Questions about Clinical Trial Regulations (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

(E) (Website) Peruvian Clinical Trials Registry (REPEC) (Spanish/Español) (Current as of March 13, 2014)
National Institute of Health, Ministry of Health, Republic of Peru

(F) (Website) Considerations for the Procedures Related to Clinical Trials in Accordance to the Clinical Trial Regulation and its Amendment (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Introduction, Title I (Articles 7 and 8) and Title IV (Chapters 1, 4, and 7), Title V (Chapter 1), Title VI (Articles 88, 92, and 93)

(2) (Regulation) Supreme Decree No. 006-2007-SA: Modification of Regulation on Clinical Trials in Peru (DecreeNo 006-2007-SA - Spanish/Español) (June 8, 2007)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Articles 39, 57, 66, and 92

(3) (Regulation) Supreme Decree No. 016-2011-SA: Regulation for the Registry, Monitoring of Medical Pharmaceuticals, Devices and Sanitary Products (DecreeNo 016-2011-SA - Spanish/Español) (July 27, 2011)
Ministry of Health, Republic of Peru

Relevant Sections: Title II (Chapter I and II) and Title III (Chapter I)

(4) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (INS CTManual - Spanish/Español) (December 2012)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Chapter III (Sections 3.1 and 3.2), Annex 1 (Application for Clinical Trial Authorization), Annex 2 (Clinical Trial Evaluation From), Annex 10 (List of Products and Supplies Used in Clinical Trial), and Annex 17 (Application for Registration of Institutional Research Ethics Committee)

(5) (Regulation) Departmental Resolution No. 239-2012-J-OPE/INS (RJ No 239-2012-OPE/INS - Spanish/Español) (July 20, 2012)
Health Sector, National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: Chapter III (1)

Clinical Trial Lifecycle > Safety Reporting
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SUMMARY

Overview
According to DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, and the INS CTManual, the following definitions provide a basis for a common understanding of Peru’s safety reporting requirements:

  • Adverse Event (or Adverse Experience) (AE) – Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product
  • Adverse Drug Reaction (ADR) – Any noxious and unintended response in a participant to an investigational medicinal product which is related to any dose administered to that participant
  • Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (SADR) or Unexpected ADR – Any AE, ADR, or unexpected ADR that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect
  • Unexpected Adverse Drug Reaction – An adverse reaction where the nature or severity is inconsistent with the applicable product information

Reporting Requirements for AEs/ADRs
Investigator Responsibilities
As specified in the INS CTManual and Additional Resources (B) and (C), the principal investigator (PI) is responsible for notifying the sponsor or his/her contract research organization (CRO) of any SAEs/SADRs. The investigator must also forward all international SAE/SADR reports from the sponsor to the ethics committee (EC). No information is available on the reporting requirements and timelines.

Sponsor Responsibilities
According to DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, the INS CTManual, and Additional Resources (B) and (C), the sponsor or his/her CRO is required to submit all expected and unexpected SAE/SADR reports electronically to the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnoligica (OGITT)) within Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) within seven (7) business days from the occurrence of the incident, or, as soon as the sponsor is aware of the incident. The submitted information above must be updated with any additional relevant information within eight (8) business days. A printed copy of the report (see the Adverse Event Reporting Form (Annex 11) of the INS CTManual or Additional Resource (B)) must be submitted to the INS in the original language, and, if necessary, translated into Spanish. The report must also be submitted to the EC.

The INS’s OGITT must also notify General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID)) of any SAEs/SADRs caused by a Peru-registered investigational product within two (2) days of receiving information about the incident and within 15 days of receiving information about all other expected and unexpected SAEs/SADRs. In addition, as per DecreeNo 017-2006-SA, the INS CTManual, and Additional Resource (B), the sponsor or his/her CRO must report all SAEs/SADRs and suspected unexpected serious adverse reactions (SUSARs) that occur in Peru and internationally as soon as possible to the INS and the EC using the CIOMS Form I or the MedWatch (U.S. Food and Drug Administration Form) and in digital form (CD).

The sponsor or his/her CRO must also electronically report non-serious AEs/ADRs quarterly or semi-annually to the INS’s OGITT. (See the Investigational Products topic for additional information on IPs.)

See the INS CTManual and Additional Resources (B) and (C) for detailed sponsor/CRO reporting requirements.

Form Completion & Delivery Requirements
As per the INS CTManual and Additional Resource (A), all AEs/ADRs, SAEs/SADRs, and SUSARs must be reported electronically by the sponsor or his/her CRO using the INS’s Serious Adverse Event Reporting System (Sistema de Reporte de Eventos Adversos Serios (REAS-NET)). All AEs/ADRs, SAEs/SADRs, and  suspected unexpected serious adverse reactions (SUSARs) must be reported on the SAE reporting form (Annex 6 in DecreeNo 017-2006-SA or Annex 11 in the INS CTManual or the CIOMS Form I (see Additional Resource (D)).

Data Safety Monitoring Board
According to the INS CTManual, a Data Safety Monitoring Board (DSMB) or a similar body must be established to regularly assess the progress of the trial.

ADDITIONAL RESOURCES

(A) (Website) Serious Adverse Event Reporting System (REAS-NET) (Spanish/Español) (Current as of April 13, 2014)
National Institute of Health, Ministry of Health, Republic of Peru

(B) (Website) Serious Adverse Event Reporting (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru
 
(C) (Website) Considerations for the Procedures Related to Clinical Trials in Accordance to the Clinical Trial Regulation and its Amendment (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: 4

(D) (Form) CIOMS Form I (Date Unavailable)
Council for International Organizations of Medical Sciences

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

(2) (Regulation) Supreme Decree No. 006-2007-SA: Modification of Regulation on Clinical Trials in Peru (DecreeNo 006-2007-SA - Spanish/Español) (June 8, 2007)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: Article 7

(3) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (Manual de Procedimientos para la Realización de Ensayos Clínicos en el Perú) (INS CTManual - Spanish/Español) (December 2012)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Chapter III (Section 3.1), Annex 2 (Clinical Trial Evaluation Form), Annex 6 (Investigator’s Brochure Guide),  and Annex 11 (File to Report Serious Adverse Events - REAS–Net and Instructions Manual)

Clinical Trial Lifecycle > Progress Reporting
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SUMMARY

Overview
In accordance with DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, the INS CTManual, and Additional Resources (A), (B), and (C), the sponsor or his/her contract research organization (CRO) is responsible for submitting progress reports and a final study report to Peru’s National Institute of Health (Instituto Nacional de Salud (INS)). As per DecreeNo 017-2006-SA, the principal investigator (PI) is responsible for submitting clinical trial progress and final reports to the research institution and the institutional ethics committee (EC).

Interim/Progress Reports
As delineated in DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, the INS CTManual, and Additional Resources (A) and (C), the sponsor or his/her CRO must submit progress reports to the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnoligica (OGITT)) within the INS quarterly or semi-annually, according to the resolution of the authorization issued, and per the format set forth in the Clinical Trial Progress Report form (See Annex 9 in DecreeNo 017-2006-SA and Annex 12 in the INS CTManual and Additional Resources (A) and (C)). For detailed report requirements, see DecreeNo 017-2006-SA, the INS CTManual, and Additional Resources (A) and (C).

Final Report
As delineated in DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, the INS CTManual, and Additional Resources (B) and (C), the sponsor or his/her CRO must submit research site final reports within 30 days, national final reports within 60 days, and international final reports within 12 months to the OGITT. The national final reports should be submitted following the closing of the research centers nationwide; the international final reports should be following the closing of the last research center internationally. The reports should comply with the format set forth in the Clinical Trial Final Report form (See Annex 10 in DecreeNo 017-2006-SA and Annex 13 in the INS CTManual and Additional Resources (B) and (C)). For detailed report requirements, see DecreeNo 017-2006-SA, the INS CTManual, and Additional Resources (B) and (C).

ADDITIONAL RESOURCES

(A) (Website) Clinical Trial Progress Report (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

(B) (Website) Clinical Trial Final Report (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

(C) (Website) Information for Investigators (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

(2) (Regulation) Supreme Decree No. 006-2007-SA: Modification of Regulation on Clinical Trials in Peru (DecreeNo 006-2007-SA - Spanish/Español) (June 8, 2007)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Article 7

(3) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (INS CTManual - Spanish/Español) (December 2012)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Chapter III (Section 3.1), Annex 12 (Clinical Trial Progress Report), and Annex 13 (Clinical Trial Final Report)

Sponsorship > Definition of Sponsor
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Last content review/update: June 07, 2017. Submit updates or comments.
SUMMARY

Overview
As per DecreeNo 017-2006-SA, the sponsor is defined as an individual, group of individuals, company, institution, or organization who takes ultimate responsibility for the initiation, management, and financing of a trial. When an independent researcher initiates and takes full responsibility for a clinical trial, then he/she assumes the role of sponsor. DecreeNo 017-2006-SA and DecreeNo 006-2007-SA also state that if the sponsor is not based in Peru, it is a statutory requirement for the sponsor to appoint a legal representative in the country for the trial’s duration.

DecreeNo 017-2006-SA, and the INS CTManual state that a sponsor can authorize a contract research organization (CRO) to carry out certain work and obligations regarding the trial. However, the sponsor is ultimately responsible for the execution of the research protocol and the results of the trial. In addition, the CRO must register with the National Institute of Health (Instituto Nacional de Salud (INS)) and annually report their clinical trial activities to the INS. See DecreeNo 017-2006-SA, and the INS CTManual for registration instructions and the application form.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

(2) (Regulation) Supreme Decree No. 006-2007-SA: Modification of Regulation on Clinical Trials in Peru (DecreeNo 006-2007-SA - Spanish/Español) (June 8, 2007)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: Article 39

(3) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (INS CTManual - Spanish/Español) (December 2012)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Chapter 3 (Section 3.2) and Annex 16 (Application for Registration of Contract Research Organization)

Sponsorship > Trial Authorization
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Last content review/update: June 07, 2017. Submit updates or comments.
SUMMARY

Overview
In accordance with DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, RJ No 239-2012-OPE/INS, the INS CTManual, and Additional Resources (A) and (B), the sponsor or his/her contract research organization (CRO) is responsible for submitting a clinical trial application to Peru's National Institute of Health (Instituto Nacional de Salud (INS)) to obtain authorization to conduct a clinical trial.

As delineated in RJ No 239-2012-OPE/INS, the INS CTManual, and Additional Resource (B), to complete the clinical trial application package, the sponsor or his/her CRO must submit a request for clinical trial authorization electronically using the Peruvian Clinical Trials Registry (Registro Peruano de Ensayos Clínicos (REPEC)), at which time, a registration code is assigned to the application. As per Additional Resource (B), one printed copy of the application must be submitted to the INS in an arch lever file (spring file folder) with the documents paginated and labeled using dividers, and ordered as indicated in the requirements listed in DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, RJ No 239-2012-OPE/INS, the INS CTManual, and Additional Resources (B), and (C). In addition to the completed application, the sponsor or the CRO must also provide the ethics committee (EC) approval letter, clinical protocol, the Investigator’s Brochure (IB), the informed consent form (ICF), and other documentation covered in the Clinical Trial Lifecycle topic, Submission Content subtopic. The application and related materials must be sent to the INS within seven (7) days of receiving the registration code. If the seven (7) day timeframe is exceeded, the application will be discarded, and another application must be submitted electronically to obtain a new registration code and initiate the process again.

ADDITIONAL RESOURCES

(A) (Website) Background on Clinical Trials Regulation (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: History of Processes Involved in Clinical Trial Legislation in Peru

(B) (Website) Information for Investigators (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: Requirement 1

(C) (Website) Considerations for the Procedures Related to Clinical Trials in Accordance to the Clinical Trial Regulation and its Amendment (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

(2) (Regulation) Supreme Decree No. 006-2007-SA: Modification of Regulation on Clinical Trials in Peru (DecreeNo 006-2007-SA - Spanish/Español) (June 8, 2007)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Articles 39, 57, and 66

(3) (Regulation) Departmental Resolution No. 239-2012-J-OPE/INS (RJ No 239-2012-OPE/INS - Spanish/Español) (July 20, 2012)
Health Sector, National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: Chapter III (1)

(4) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (INS CTManual - Spanish/Español) (December 2012)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Chapter III (Section 3.1), Annex 1 (Application for Clinical Trial Authorization), and Annex 17 (Application for Registration of Institutional Research Ethics Committee)

Sponsorship > Insurance
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Last content review/update: June 07, 2017. Submit updates or comments.
SUMMARY

Overview
As set forth in DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, RJ No 239-2012-OPE/INS, the INS CTManual, and Additional Resources (A) and (B), it is a legal requirement for the sponsor or his/her contract research organization (CRO) to carry a valid insurance policy for the expected duration of the study for any unforeseen injury to research participants. DecreeNo 006-2007-SA also specifies that the sponsor or his/her CRO must obtain insurance coverage in Peru, or have a legal representative in Peru who will represent the sponsor or his/her CRO if the policy is from another country.

See the Sponsorship topic, Compensation subtopic and Informed Consent topic, Compensation Disclosure subtopic for specific details related to sponsorship compensation obligations.

ADDITIONAL RESOURCES

(A) (Website) Information for Investigators (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: Requirement 1

(B) (Website) Considerations for the Procedures Related to Clinical Trials in Accordance to the Clinical Trial Regulation and its Amendment (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

(2) (Regulation) Supreme Decree No. 006-2007-SA: Modification of Regulation on Clinical Trials in Peru (DecreeNo 006-2007-SA - Spanish/Español) (June 8, 2007)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Articles 26, 39, and 66

(3) (Regulation) Departmental Resolution No. 239-2012-J-OPE/INS (RJ No 239-2012-OPE/INS - Spanish/Español) (July 20, 2012)
Health Sector, National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: Chapter III (1)

(4) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (Manual de Procedimientos para la Realización de Ensayos Clínicos en el Perú) (INS CTManual - Spanish/Español) (December 2012)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Chapter III (Section 3.1), Annex 1 (Application for Clinical Trial Authorization), Annex 2 (Clinical Trial Evaluation Form), Annex 5 (Research Protocols Guide), and Annex 9 (Sworn Statement for Budget to Compensate and Cover Expenses Due to Damages Occurred as a Result of the Participation in the Clinical Trial)

Sponsorship > Compensation
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Last content review/update: June 07, 2017. Submit updates or comments.
SUMMARY

Overview
As specified in DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, RJ No 239-2012-OPE/INS, the INS CTManual, and Additional Resources (A) and (B), the sponsor or his/her contract research organization (CRO) is responsible for providing compensation to research participants and/or their legal heirs in the event of trial-related injuries or death. DecreeNo 006-2007-SA also specifies that the sponsor or his/her CRO must obtain insurance coverage in Peru or have a legal representative in Peru who will represent the sponsor or his/her CRO if the policy is from another country. In addition, the sponsor or his/her CRO must submit a sworn statement guaranteeing the budget to cover possible injuries resulting from participation in the trial (see Annex 11 of DecreeNo 017-2006-SA and Annex 9 of the INS CTManual and Additional Resource (A)). The sponsor or his/her CRO must also ensure that participants who suffer any trial-related injuries are provided with free medical treatment for such injuries.

(See Informed Consent topic, Compensation Disclosure subtopic for more information on participant compensation rights).

ADDITIONAL RESOURCES

(A) (Website) Information for Investigators (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: Requirement 1

(B) (Website) Considerations for the Procedures Related to Clinical Trials in Accordance to the Clinical Trial Regulation and its Amendment (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

(2) (Regulation) Supreme Decree No. 006-2007-SA: Modification of Regulation on Clinical Trials in Peru (DecreeNo 006-2007-SA - Spanish/Español) (June 8, 2007)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Articles 26, 27, 39, and 66

(3) (Regulation) Departmental Resolution No. 239-2012-J-OPE/INS (RJ No 239-2012-OPE/INS - Spanish/Español) (July 20, 2012)
Health Sector, National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: Chapter III (1)

(4) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (INS CTManual - Spanish/Español) (December 2012)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Chapter III (Section 3.1), Annex 1 (Application for Clinical Trial Authorization), Annex 2 (Clinical Trial Evaluation Form), Annex 5 (Research Protocols Guide), and Annex 9 (Sworn Statement for Budget to Compensate and Cover Expenses Due to Damages Occurred as a Result of the Participation in the Clinical Trial)

Sponsorship > Quality, Data & Records Management
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Last content review/update: June 23, 2016. Submit updates or comments.
SUMMARY

Overview
No relevant regulatory provisions are currently available regarding the sponsor’s role in implementing and maintaining quality assurance and quality control systems including record management, audit procedures, or electronic data processing systems.

Premature Study Termination/Suspension
DecreeNo 017-2006-SA states that the sponsor or his/her contract research organization (CRO) is responsible for submitting the required documentation to the Peru's National Institute of Health (Instituto Nacional de Salud (INS)) to request a trial’s suspension. The request must include a report providing the reasons for the suspension, including all the data up to the time of the suspension, and measures to be taken to protect the research participants.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (Decreto Supremo No. 017-2006-SA: Aprueban el Reglamento de Ensayos Clínicos en el Perú) (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

Sponsorship > Site/Investigator Selection
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Last content review/update: July 05, 2017. Submit updates or comments.
SUMMARY

Overview
As set forth in DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, RJ No 239-2012-OPE/INS, the INS CTManual, the sponsor or his/her contract research organization (CRO) is responsible for selecting the investigator(s) and the institution(s) for the clinical trial, taking into account the appropriateness and availability of the study site and facilities. The sponsor must also ensure that the investigator(s) are qualified by training and experience. As delineated in DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, RJ No 239-2012-OPE/INS, and the INS CTManual, prior to entering into an agreement with the investigator(s) and the institution(s) to conduct a study, the sponsor or his/her CRO should provide the investigator(s) with the protocol and an investigator’s brochure.

No information is currently available regarding the sponsor’s role in overseeing multicenter trials.

Foreign Sponsor Responsibilities
DecreeNo 017-2006-SA and DecreeNo 006-2007-SA state that if the sponsor is not based in Peru, it is a statutory requirement for the sponsor to appoint a legal representative in the country for the trial’s duration. As specified in DecreeNo 006-2007-SA, the sponsor may transfer any or all of his/her study related duties and functions to a CRO. However, he/she is ultimately responsible for the execution of the research protocol and results of the clinical trial.

Data Safety Monitoring Board (DSMB)
According to the INS CTManual, a DSMB or a similar body must be established to regularly assess the progress of the trial.

ADDITIONAL RESOURCES

(A) (Website) Norms (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

(B) (Website) Requirements for Project Evaluation (Spanish/Español) (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

(C) (Website) Registration of Institutional Research Ethics Committee (Current as of August 4, 2016)
National Institute of Health, Ministry of Health, Republic of Peru

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

(2) (Regulation) Supreme Decree No. 006-2007-SA: Modification of Regulation on Clinical Trials in Peru (DecreeNo 006-2007-SA - Spanish/Español) (June 8, 2007)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Article 7, Article 39, Article 57, and Article 66

(3) (Regulation) Departmental Resolution No. 239-2012-J-OPE/INS (RJ No 239-2012-OPE/INS - Spanish/Español) (July 20, 2012)
Health Sector, National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: Chapter III (1)

(4) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (INS CTManual - Spanish/Español) (December 2012)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Chapter III (Sections 3.1 and 3.2) and Annex 17 (Application for Registration of Institutional Research Ethics Committee)

Informed Consent > Documentation Requirements
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Last content review/update: June 23, 2016. Submit updates or comments.
SUMMARY

Overview
In all Peruvian clinical trials, a freely given informed consent must be obtained from each participant in accordance with the requirements set forth in DecreeNo 017-2006-SA. The informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by an institutional ethics committee (EC) and provided to Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) with the clinical trial application. (See the Informed Consent topic, Required Elements subtopic for details on what should be included in the form.)

Investigator(s) must provide detailed research study information to the participant and/or his/her legal representative(s) or guardian(s). The ICF content should be briefly and clearly presented in writing, in a manner that is easy to understand, commensurate with the comprehension level of the research participants, and without coercion or unduly influencing a potential participant to enroll in the clinical trial. When drafting and presenting the ICF, special consideration must be taken with regard to the participant’s culture, traditional values, intelligence, and education. The participant and his/her legal representative(s) or guardian(s) should also be given adequate time to consider whether to participate.

Re-Consent
The participant and/or his/her legal representative(s) or guardian(s) is required to sign a revised ICF if any changes occur in the protocol or in the treatment methods or procedures.

Language Requirements
The ICF must be written in Spanish and in the language of the research participant.

Documentation Copies
The participant and/or the participant’s legal representative(s) or guardian(s), and the investigator(s) must sign and date the ICF. Where the participant is illiterate and/or his/her legal representative(s) or guardian(s) is illiterate, his/her fingerprint will serve as a signature, and should be obtained in the presence of and countersigned by an impartial witness who does not belong to the research team. Before participating in the study, the participant should receive a copy of the signed and dated ICF.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

Informed Consent > Required Elements
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Last content review/update: June 23, 2016. Submit updates or comments.
SUMMARY

Overview
As delineated in DecreeNo 017-2006-SA, prior to beginning a clinical trial, the sponsor or his/her contract research organization (CRO) is required to obtain ethics committee (EC) approval from an institutional EC for the written informed consent form (ICF) and any other information being provided to the research participant and/or his/her legal representative(s) or guardian(s).

No Coercion
None of the information concerning the research study, including the written ICF, should contain any language that causes the participant and/or his/her legal representative(s) or guardian(s) to waive or to appear to waive his/her legal rights, or that releases or appears to release the investigator(s), the institution, the sponsor, or their representatives from their liabilities for any negligence.

ICF Required Elements
The ICF should include the following statements or descriptions, as applicable:

  • The study purpose, the procedures, and duration of the trial
  • The approximate number of participants in the study
  • Any expected risks or discomforts to the participant
  • Any expected benefits to the participant
  • Treatments available to participants and how they are administered
  • Compensation and treatment available for the participant in the case of trial-related injury
  • The disclosure of specific appropriate alternative procedures or therapies available to the participant
  • Procedures for recruitment and randomization
  • The extent to which confidentiality of records identifying the participant will be maintained and who may have access to these records
  • That participation is voluntary, and that the participant can withdraw from the study at any time without penalty or loss of benefits, including medical treatment, to which the participant is otherwise entitled
  • Contact information for the sponsor and investigator in the event of participant problems or trial-related injuries
  • Foreseeable circumstances under which the investigator(s) may remove the participant without his/her consent
  • The consequences of a participant’s decision to withdraw from the research and procedures for orderly withdrawal by the participant
  • That the participant and/or his/her legal representative(s) or guardian(s) will be notified in a timely manner if significant new findings develop during the course of the study which may affect the participant's willingness to continue


See the Informed Consent topic, Compensation Disclosure subtopic and Vulnerable Population subtopic for further information.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

Informed Consent > Compensation Disclosure
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Last content review/update: June 23, 2016. Submit updates or comments.
SUMMARY

Overview
In accordance with DecreeNo 017-2006-SA, the informed consent form (ICF) should contain a statement describing the compensation and medical treatment a participant can receive for participating in a clinical trial.

Compensation for Participation in Research
Trial participants should be compensated for travel, accommodations, supplies purchased, and other expenses incurred while participating in the trial. The ICF must also explicitly state what expenses will be covered as a result of participation.

Compensation for Injury
The ICF should include a statement advising the participant that compensation and medical treatment is available in the event of any trial-related injury. (See the Informed Consent topic, Required Elements subtopic for additional details on what should be included in the ICF.)

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

Informed Consent > Participant Rights
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Last content review/update: June 23, 2016. Submit updates or comments.
SUMMARY

Overview
In accordance with DecreeNo 017-2006-SA, Peru’s ethical standards promote respect for all human beings and safeguard the rights of research participants. A participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process.

The Right to Participate, Abstain, or Withdraw
The participant or his/her legal representative(s) or guardian(s) should be informed that participation is voluntary, that he/she may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled.

The Right to Information
A potential research participant and/or his/her legal representative(s) or guardian(s) has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, any compensation for participation or injury/treatment, and any significant new information regarding the research study.

The Right to Privacy and Confidentiality
All participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right.

The Right of Inquiry/Appeal
The research participant and/or his/her legal representative(s) or guardian(s) should be provided with contact information for the sponsor and the investigator(s) to address trial-related inquiries and/or to appeal against a violation of his/her rights.

The Right to Safety and Welfare
The research participant’s dignity, safety, and welfare must be guaranteed while ensuring the quality of the research process in developing new products.
 
See the Informed Consent topic, and the subtopics of Required Elements and Vulnerable Populations for additional information regarding requirements for participant rights.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (Decreto Supremo No. 017-2006-SA: Aprueban el Reglamento de Ensayos Clínicos en el Perú) (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

Informed Consent > Special Circumstances/Emergencies
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Last content review/update: June 23, 2016. Submit updates or comments.
SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Informed Consent > Vulnerable Populations
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Last content review/update: June 23, 2016. Submit updates or comments.
SUMMARY

Overview
As per DecreeNo 017-2006-SA, in all Peruvian clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. Vulnerable populations are those who are relatively (or absolutely) incapable of protecting their own interests due to a lack of autonomy, intelligence, education, resources, strength, or other necessary attributes. This may include those in subordinate groups, those with incurable diseases, people in convalescent homes, the unemployed or indigent, patients in emergency situations, ethnic minorities, homeless people, nomads, refugees, minors, and those who cannot give their consent.

See the Informed Consent topic, and the subtopics of Children/Minors; Pregnant Women, Fetuses & Neonates; and Mentally Impaired for additional information about these vulnerable populations. Information on the other vulnerable populations specified in DecreeNo 017-2006-SA is provided below.

Geriatrics
Geriatric patients should only be included in clinical trials under the following circumstances:

  • The disease intended to be treated is typically a disease of aging
  • The protocol is approved by an ethics committee (EC) that has members specializing in the disease to be studied or has obtained advice from those with expertise in the disease area or in the patient population

Persons in Subordinate or Dependent Groups
Clinical trials involving participants who are involved in subordinate or dependent relationships must meet the following requirements:

  • One or more of the EC’s members must represent the population under study or work with someone who has expertise in addressing social, cultural, and other issues related to the group in question
  • A participant’s refusal or withdrawal of consent during the trial should not affect his/her performance review or result in any negative consequences to the participant

These relationships include participants who are in junior or subordinate positions in hierarchically structured groups, such as students and teachers, employees and their supervisors, and soldiers and their superiors in military settings.

Research Involving Indigenous Communities
Clinical trials involving participants from indigenous communities may only be conducted under the following conditions:

  • When the expected benefit is reasonably assured; that is, when the product or knowledge generated by research is available or applied for the benefit of the community
  • The principal investigator (PI) has the approval to conduct the trial from the regional health authority and other authorities in the community, in addition to obtaining informed consent from individuals who are included in the trial
  • Sponsors and investigators develop culturally appropriate ways through working with anthropologists, sociologists, and translators to communicate the necessary information, and to meet the standards required in the informed consent process. In addition, the research protocol must describe and justify the methods the investigators plan to use to communicate information to research participants
  • Investigators agree to discontinue using individual participants when the community does not have the capacity to understand the implications of the participants’ involvement in the trial, despite the use of a translator or interpreter

Research Involving Participants with Physical Disabilities
In clinical trials involving participants with physical disabilities that prevent them from signing the informed consent form (ICF), but with the mental capacity to provide their consent, their legal representative(s) are required to sign the ICF. Consent may also be withdrawn by the participant and/or his/her legal representative(s) at any time without negative consequences as long as the withdrawal does not jeopardize the participant’s health.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

(2) (Regulation) Supreme Decree No. 020-2015-SA (Decree No 020-2015-SA - Spanish/Español) (June 18, 2015)
Ministry of Health, Republic of Peru

Informed Consent > Children/Minors
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Last content review/update: June 23, 2016. Submit updates or comments.
SUMMARY

Overview
The applicable regulatory requirements do not specify the age of minors. DecreeNo 017-2006-SA states that a child aged 10 years or older must give his/her consent as a research participant in addition to the consent of both parents or his/her legal representative(s) and/or guardian(s). The consent of the legal representative(s) or guardian(s) may only be dismissed in the case of death; if the consent is obtained from an unreliable source(s); loss of legal/guardianship rights; or if the child faces an imminent health risk or his/her life is endangered.

All pediatric participants should be fully informed about the trial and its risks and benefits in a language and terms that they are easily able to understand. The investigator(s) must also accept the withdrawal of informed consent at the request of the child’s legal representative(s) or guardian(s) at any time, provided that the child’s health will not be jeopardized. A minor who is a teenager must also be excluded from a trial when a conflict of views exists between the legal representative(s) or guardian(s) and the teenager.

In addition, the protocol must also be approved by an ethics committee (EC) that has a specialist in pediatrics or has obtained advice on the clinical, ethical, and psycho-social aspects of the trial from a pediatric expert, if applicable.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

(2) (Regulation) Supreme Decree No. 020-2015-SA (Decree No 020-2015-SA - Spanish/Español) (June 18, 2015)
Ministry of Health, Republic of Peru

Informed Consent > Pregnant Women, Fetuses & Neonates
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Last content review/update: June 23, 2016. Submit updates or comments.
SUMMARY

Overview
As per DecreeNo 017-2006-SA, studies involving women of childbearing age or who are pregnant require additional safeguards to ensure that the research assesses the risks and benefits as well as any potential impact on fertility, pregnancy, the embryo or fetus, labor, lactation, and the newborn.

Clinical trials may only be conducted under the following conditions:

  • The informed consent of the woman and her spouse or partner is obtained, and they are given information about any potential risks to the embryo, fetus, or newborn prior to the trial
  • The spouse’s or partner’s consent may only be dismissed in the case of death; their inability to provide reliable consent; loss of rights; or, when there is imminent risk to the health or life of the woman or the embryo, fetus, or newborn
  • Informed consent may be withdrawn by the woman or spouse’s or partner’s request at any time, without detriment to them, provided the woman or fetus is not endangered
  • The research must be preceded by trials in non-pregnant women to demonstrate their safety, except for specific tests that require pregnant participants
  • The research must be aimed at improving the health of pregnant women and represent only a minimal risk to the embryo or fetus and the participant
  • During the study, investigators will not have the authority to decide on the timing, method, or procedure used to terminate the pregnancy, or to participate in decisions about the viability of the fetus
  • Informed consent for pregnant teenagers complies with the requirements stated in the Informed Consent topic, Children/Minors subtopic

Clinical trials may only be carried out in women in labor, postpartum, or breastfeeding when the following conditions are met:

  • Consent must be obtained before labor starts
  • Research will be authorized in postpartum women and breastfeeding only when there is minimal risk to the infant
  • Informed consent may be withdrawn at the participant’s or spouse’s or partner’s request at any time, without detriment to them, provided they do not affect or endanger the mother or the fetus or infant

See Title III, Chapter II (Article 22) of DecreeNo 017-2006-SA for additional details on embryos, fetuses, and newborns.

Research Involving Men and Women with Reproductive Capacity
Clinical trials involving men and women with reproductive capacity are only permitted under the following conditions:

  • For women, the principal investigator (PI) must conduct a pregnancy test to rule out any pregnancies, and to secure commitment from the women to use effective contraceptive methods
  • In the event of pregnancy during the study, the protocol should establish the exclusion of the mother and the application of procedures to monitor and control the pregnancy
  • For men, the PI must secure a commitment from the men to prevent conception, and to use effective contraceptive methods
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

Informed Consent > Prisoners
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Last content review/update: June 23, 2016. Submit updates or comments.
SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Informed Consent > Mentally Impaired
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Last content review/update: June 23, 2016. Submit updates or comments.
SUMMARY

Overview
According to DecreeNo 017-2006-SA, the following conditions must be met for clinical trials involving participants who are mentally incapable of giving consent:

  • Informed consent must be obtained from the legal representative(s) or guardian(s) who have been informed of the possible risks, discomforts, and benefits of the trial
  • Obtain informed consent from the participant when he/she has been fully informed about the trial in easily understandable language
  • Consent may be withdrawn at any time without harm to the participant and/or his/her legal representative(s) or guardian(s)
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

Investigational Products > Definition of Investigational Product
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Last content review/update: June 07, 2017. Submit updates or comments.
SUMMARY

Overview
As delineated in DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, and the INS CTManual, an investigational product is defined as a pharmaceutical form of an active substance or placebo, being tested or used as an active comparator in a clinical trial. This includes a product with a marketing authorization when it is used or assembled (formulated or packaged) in a different way from the approved form, when used for an unapproved indication, or when used to gain further information about an approved use.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

(2) (Regulation) Supreme Decree No. 006-2007-SA: Modification of Regulation on Clinical Trials in Peru (DecreeNo 006-2007-SA - Spanish/Español) (June 8, 2007)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: Article 7

(3) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (INS CTManual - Spanish/Español) (December 2012)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: Annex 20

Investigational Products > Manufacturing & Import
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Last content review/update: June 07, 2017. Submit updates or comments.
SUMMARY

Overview
According to DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, and DecreeNo 016-2011-SA, the sponsor or his/her contract research organization (CRO) must obtain approval from the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID)) to manufacture or import investigational products (IPs) in Peru. As per DecreeNo 017-2006-SA and DecreeNo 006-2007-SA, Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) must approve the clinical trial application prior to DIGEMID’s approval of an IP. However, the INS does request DIGEMID to assess the safety profile of the IP to be used in a clinical trial as part of its application review and approval process.

DecreeNo 017-2006-SA and DecreeNo 016-2011-SA specify that DIGEMID will authorize the import of IPs exclusively for research involving humans when the applicant can provide information to support the product’s safety and quality according to the stage and type of research being conducted. Documentation requirements for DIGEMID’s approval are as follows:

  • Import application request form with an affidavit
  • Copy of INS clinical trial authorization approval
  • IP labeling protocol
  • Good Manufacturing Practices (GMPs) certificate issued by the regulatory authority of the country of origin
  • Certificate of free sale of country of origin or Pharmaceutical Product Certificate (see Additional Resource (B) for World Health Organization certificate model) if the research product is marketed in another country
  • Proof of payment for processing fee

See Clinical Trial Lifecycle topic, Timeline of Review subtopic for additional information on DIGEMID’s role in the clinical trial application approval process.

ADDITIONAL RESOURCES

(A) (Website) General Directorate of Medicines, Supplies and Drugs (DIGEMID) (Spanish/Español) (Current as of March 13, 2014)
Ministry of Health of Peru, Republic of Peru

(B) (Guidance) Use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce - EDM Research Series No. 016 (1995)
World Health Organization

Relevant Section: Annex 3 (b): Certificate of Pharmaceutical Product(s)

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

(2) (Regulation) Supreme Decree No. 006-2007-SA: Modification of Regulation on Clinical Trials in Peru (DecreeNo 006-2007-SA - Spanish/Español) (June 8, 2007)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Articles 7, 39, 66, and 68

(3) (Regulation) Supreme Decree No. 016-2011-SA: Regulation for the Registry, Monitoring of Medical Pharmaceuticals, Devices and Sanitary Products (DecreeNo 016-2011-SA - Spanish/Español) (July 27, 2011)
Ministry of Health, Republic of Peru

Relevant Sections: Title II (Chapter I and V) and Title III (Chapter I)

(4) (Regulation) Departmental Resolution No. 239-2012-J-OPE/INS (RJ No 239-2012-OPE/INS - Spanish/Español) (July 20, 2012)
Health Sector, National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: Chapter III (1)

Investigational Products > IMP/IND Quality Requirements
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Last content review/update: June 07, 2017. Submit updates or comments.
SUMMARY

Overview
In accordance with DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, RJ No 239-2012-OPE/INS, and the INS CTManual, the sponsor or his/her contract research organization (CRO) is responsible for providing the investigators with an Investigator’s Brochure (IB). The IB must contain all of the relevant information on the investigational product(s) (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse events data. The sponsor should also update the IB as significant new information becomes available.

IB Content Requirements
As specified in DecreeNo 017-2006-SA, the IB must provide coverage of the following areas:

  • Physical, chemical, and pharmaceutical properties and formulation parameters
  • Non-clinical studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles)
  • Effects of IP in humans (pharmacology, pharmacokinetics, metabolism, and pharmacodynamics; safety and efficacy; regulatory and post marketing experiences)
  • Summary of data and guidance for the investigator(s)
  • Bibliography

See Annex 2 of DecreeNo 017-2006-SA for detailed content guidelines.

As defined in DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, RJ No 239-2012-OPE/INS, and the INS CTManual, the sponsor must also supply the investigator(s)/institution(s) with the IP(s), including the comparator(s) and placebo, if applicable.

As specified in DecreeNo 017-2006-SA and DecreeNo 006-2007-SA, Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) requires the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID)) to assess the safety profile of the IP to be used in a clinical trial as part of its application review and approval process. DIGEMID’s assessment must be completed within 30 days.

As per DecreeNo 017-2006-SA, the IP must also meet at least one of the following conditions to be authorized for use in clinical trials in Peru:

  • Must be approved for use in the either US, the European Union, Japan, Canada, or Australia
  • Is produced in Peru as a result of preclinical research, and complies with Ministerio de Salud del Perú (Ministry of Health of Peru) (MINSA)) political and/or research priorities
  • Will serve to establish pharmaceutical therapeutic equivalence

Drug Manufacturing Certificate Requirements
As stated in DecreeNo 016-2011-SA and DecreeNo 017-2006-SA, the manufacture of IPs for their use in a clinical trial must be approved by DIGEMID. DecreeNo 017-2006-SA and DecreeNo 006-2007-SA, and also specify that the sponsor or his/her CRO must ensure the products are manufactured in accordance with the current codes of Good Manufacturing Practice (GMP).

In addition, the sponsor or his/her CRO must complete the Listing of Products and Provisions to Use in the Clinical Trial Form (Annex 5 in DecreeNo 017-2006-SA and Annex 10 in RJ No 239-2012-OPE/INS and the INS CTManual). This form requires the sponsor or his/her CRO to provide the following data:

  • Name of product
  • Active ingredient(s)
  • Pharmaceutical form and concentration
  • Manufacturer name
  • Country of origin
  • Amount
  • Coding system

(See Investigational Product topic, Product Management subtopic for additional information on sponsor requirements).

ADDITIONAL RESOURCES

(A) (Website) General Directorate of Medicines, Supplies and Drugs (DIGEMID) (Spanish/Español) (Current as of March 13, 2014)
Ministry of Health of Peru, Republic of Peru

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

(2) (Regulation) Supreme Decree No. 006-2007-SA: Modification of Regulation on Clinical Trials in Peru (DecreeNo 006-2007-SA - Spanish/Español) (June 8, 2007)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Articles 7, 39, 66, and 68

(3) (Regulation) Supreme Decree No. 016-2011-SA: Regulation for the Registry, Monitoring of Medical Pharmaceuticals, Devices and Sanitary Products (DecreeNo 016-2011-SA - Spanish/Español) (July 27, 2011)
Ministry of Health, Republic of Peru

Relevant Sections: Title II (Chapter I and V) and Title III (Chapter I), and Annex 5

(4) (Regulation) Departmental Resolution No. 239-2012-J-OPE/INS (RJ No 239-2012-OPE/INS - Spanish/Español) (July 20, 2012)
Health Sector, National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Chapter III (1) and Annex 10

(5) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (INS CTManual - Spanish/Español) (December 2012)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Chapter 3 (Section 3.1) and Annexes 1 and 6

Investigational Products > Labeling & Packaging
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Last content review/update: June 07, 2017. Submit updates or comments.
SUMMARY

Overview
Investigational product (IP) labeling in Peru must comply with the requirements set forth in DecreeNo 017-2006-SA and DecreeNo 006-2007-SA. IPs to be used in a clinical trial must be properly labeled in the Spanish language and printed in indelible ink.

In addition, the following information must be included as a minimum on the product label:

  • Name, address and telephone number of the sponsor or contract research organisation (CRO)
  • Trial number and/or trial title
  • IP name or unique code
  • Date of IP’s maturity or reanalysis
  • Manufacturing lot number
  • Number of units and pharmaceutical form
  • Route of administration
  • Special storage and conservation requirements
  • “For clinical trial use only”, “not for sale”, or similar wording indicating the IP is clinical trial material

In double-blind trials where the IP character, lot number, and manufacturer’s name is not included on the label, the package must include a document that links to information that identifies possible blinded treatments. Furthermore, the labeling must indicate the most restrictive storage requirements on both products.

(See Investigational Product topic, Product Management subtopic for additional information on investigational medicinal product (IMP) supply, storage, and handling requirements).

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

(2) (Regulation) Supreme Decree No. 006-2007-SA: Modification of Regulation on Clinical Trials in Peru (DecreeNo 006-2007-SA - Spanish/Español) (June 8, 2007)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Section: Article 89

Investigational Products > Product Management
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Last content review/update: June 07, 2017. Submit updates or comments.
SUMMARY

Overview
In accordance with DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, RJ No 239-2012-OPE/INS, and the INS CTManual, the sponsor or his/her contract research organization (CRO) is responsible for providing the investigators with an Investigator’s Brochure (IB). The IB must contain all of the relevant information on the investigational product(s) (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse events data. The sponsor should also update the IB as significant new information becomes available.

Investigational Product Supply, Storage, and Handling Requirements
As defined in DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, RJ No 239-2012-OPE/INS, and the INS CTManual, the sponsor must also supply the investigator(s)/institution(s) with the IP(s), including the comparator(s) and placebo, if applicable. The sponsor or his/her designated CRO should not supply either party with the IP(s) until he/she obtains approval from Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) and an INS-registered ethics committee (EC). In addition, according to DecreeNo 017-2006-SA, DecreeNo 006-2007-SA, and DecreeNo 016-2011-SA, the sponsor or his/her CRO must obtain approval from the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos Insumos y Drogas (DIGEMID)) to manufacture or import IPs in Peru. The sponsor or his/her CRO must complete the Listing of Products and Provisions to Use in the Clinical Trial Form (Annex 5 in DecreeNo 017-2006-SA and Annex 10 in RJ No 239-2012-OPE/INS and the INS CTManual. This form requires the sponsor or his/her CRO to provide the following data:

  • Name of product
  • Active ingredient(s)
  • Pharmaceutical form and concentration
  • Manufacturer name
  • Country of origin
  • Amount
  • Coding system

As per DecreeNo 017-2006-SA, the IP must also meet one of the following conditions to be authorized for use in clinical trials in Peru:

  • Must be approved for use in either the US, the European Union, Japan, Canada, or Australia
  • Is produced in Peru as a result of preclinical research, and complies with Ministerio de Salud del Perú (Ministry of Health of Peru) (MINSA)) political and/or research priorities
  • Will serve to establish pharmaceutical therapeutic equivalence

Further detailed information on specific IP requirements that the sponsor or his/her CRO must ensure is currently unavailable.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Supreme Decree No. 017-2006-SA: Regulation on Clinical Trials in Peru (DecreeNo 017-2006-SA - Spanish/Español) (July 29, 2006)
National Institute of Health, Ministry of Health, Republic of Peru
 
Relevant Section: Title I (Article 5)

(2) (Regulation) Supreme Decree No. 006-2007-SA: Modification of Regulation on Clinical Trials in Peru (DecreeNo 006-2007-SA - Spanish/Español) (June 8, 2007)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Articles 7, 39, and 66

(3) (Regulation) Supreme Decree No. 016-2011-SA: Regulation for the Registry, Monitoring of Medical Pharmaceuticals, Devices and Sanitary Products (DecreeNo 016-2011-SA - Spanish/Español) (July 27, 2011)
Ministry of Health, Republic of Peru

Relevant Sections: Title II (Chapter I and II) and Title III (Chapter I)

(4) (Regulation) Departmental Resolution No. 239-2012-J-OPE/INS (RJ No 239-2012-OPE/INS - Spanish/Español) (July 20, 2012)
Health Sector, National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Chapter III (1) and Annex 10

(5) (Guidance) Manual of Procedures for the Accomplishment of Clinical Trials in Peru (Manual de Procedimientos para la Realización de Ensayos Clínicos en el Perú) (INS CTManual - Spanish/Español) (December 2012)
National Institute of Health, Ministry of Health, Republic of Peru

Relevant Sections: Chapter III (Section 3.1), Annex 1 (Application for Clinical Trial Authorization), and Annex 6 – Investigators Brochure Guide)

Specimens > Definition of Specimen
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Last content review/update: June 28, 2016. Submit updates or comments.
SUMMARY

No relevant provisions are currently available that define specimens.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Specimens > Import & Export
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Last content review/update: June 28, 2016. Submit updates or comments.
SUMMARY

No relevant provisions are currently available regarding the import or export of specimens.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Specimens > Consent for Specimens
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Last content review/update: June 28, 2016. Submit updates or comments.
SUMMARY

No relevant provisions are currently available regarding consent for specimens.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

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Expiration Date: 2/28/2019