Brazil Profile Updated

Brazil Profile Updated

The Brazil profile in ClinRegs has been reviewed and updated with the following information:

• New regulation amending investigational product import procedures (See Manufacturing & Import and Specimen Import & Export) 
• New regulation on Certification of Good Practices for conducting bioavailability/bioequivalence drug studies (See Quality, Data & Records Management) 
• Updated GCP inspection guides for clinical trial centers and sponsors/clinical research organization representatives (See Quality, Data & Records Management) 
• New guideline on registering advanced therapy product import licenses for clinical research purposes with ANVISA via SISCOMEX’s Single Portal (See Manufacturing & Import) 
• New CONEP circular on submitting administrative documents to accelerate research ethics committee accreditation/renewal (See Ethics Committee and Authorizing Body) 
• Updated information on the ANVISA request process for global transfer of responsibility of clinical trials (See Trial Authorization and Manufacturing & Import) 
• New technical guideline on completing expiration date information in the Clinical Trial Submission Form (See Submission Content, Trial Authorization, and Manufacturing & Import) 
• New webpages on obtaining a drug import license authorization and checking on petition submission status (See Submission Process and Manufacturing & Import) 
• Information on preparing reports on biobanks for research purposes (See Specimen Import & Export) 

Sources Added During this Update:

(Legislation) Constitutional Amendment No. 115 of February 10, 2022 (C-AmndtNo115 – Portuguese) (February 10, 2022)
National Congress

(Regulation) Normative Instruction No. 122 of March 9, 2022 – Provides Good Clinical Practice Inspection Procedures for Clinical Drug Trials (NormNo122 - Portuguese) (Effective April 1, 2022)
ANVISA, Ministry of Health

(Regulation) Resolution of the Collegiate Board – RDC No. 613 of March 9, 2022 (ResNo613 - Portuguese) (Effective April 1, 2022)
ANVISA, Ministry of Health

(Regulation) Resolution of the Collegiate Board of Directors - RDC No. 620 of March 9, 2022 (ResNo620 - Portuguese) (Effective April 1, 2022)
ANVISA, Ministry of Health

(Circular) Circular Letter No. 1/2022 - Use of an Electronic Mail System (E-mail) to Send Administrative Documents from Research Ethics Committees (CEP) (CLNo1-2022 - Portuguese) (February 7, 2022)
National Research Ethics Commission, Executive Secretariat of the National Health Council, Ministry of Health

(Guidance) Primer: Import Petition through LPCO (G-LPCOImprtPetition - Portuguese) (Version 3.2) (March 31, 2022)
ANVISA, Ministry of Health

(Form) Online Adverse Event Notification Form for Advanced Therapy Products (BRA-101 – Portuguese) (Current as of May 11, 2022)
ANVISA, Ministry of Health

(Document) Location of Available Documents on the ANVISA Portal (COPEC) (BRA-98 - Portuguese) (21^th Edition) (March 10, 2022)
ANVISA, Ministry of Health

(Document) Pharmaceutical Inspection Co-operation Scheme (PIC/S) Brochure (BRA-100) (August 2019)
Pharmaceutical Inspection Co-operation Scheme (PIC/S)

(Document) Roadmap for Preparing Reports on Biobanks for Research Purposes (BRA-97 - Portuguese) (Version 02) (February 2, 2022)
National Research Ethics Commission, National Health Council, Ministry of Health

(Document) Technical Note No. 01/2022: Guidelines on Completing the Clinical Trial Submission Form (FAEC) Regarding the Expiration Date of Medicines and Products to be Imported for Conducting Clinical Trials in Brazil, Pursuant to RDC No. 9/2015 (BRA-95 - Portuguese) (February 2, 2022)
ANVISA, Ministry of Health

(Article) Advanced Research Therapy Product Imports: Pilot Project Migrates to Single Foreign Trade Portal (BRA-86 - Portuguese) (September 20, 2021)
ANVISA, Ministry of Health

(Article) Clinical trials: New Flow for Requesting a Global Transfer of Responsibility (BRA-96 - Portuguese) (Last Updated November 25, 2021)
ANVISA, Ministry of Health

(Article) Import No. 046/2021 – Inclusion of Products in ANVISA’s Administrative Treatment (BRA-94 - Portuguese) (Last Updated September 20, 2021)
Siscomex, Government of Brazil

(Webpage) ANVISA - Document Status Query Tool (BRA-102 - Portuguese) (Current as of May 11, 2022)
ANVISA, Ministry of Health

(Webpage) ANVISA - Obtain Authorization to Import Drug Substance (BRA-103 - Portuguese) (Last Updated March 4, 2022)
ANVISA, Ministry of Health

(Webpage) ANVISA - Public Service Center (BRA-99 - Portuguese) (Current as of May 11, 2022)
ANVISA, Ministry of Health

(Webpage) ANVISA - Request Product Import Licensing Subject to Sanitary Surveillance through LPCO (BRA-104 - Portuguese) (Last Updated March 14, 2022)
ANVISA, Ministry of Health

(Webpage) Brazil Platform (BRA-93 - Portuguese) (Last Updated November 23, 2020)
Ministry of Health

(Webpage) Learning to Export - Siscomex Single Portal (BRA-87 - Portuguese) (Last Updated December 29, 2021)
Siscomex, Government of Brazil

Sources Revised During this Update:

(Guidance) Inspection Guide on Good Clinical Practice (GCP) for Clinical Trials with Drugs and Biological Products - Inspection in Clinical Trial Centers (GuideNo35-2020 - Portuguese) (Version 2) (Effective January 27, 2022)
ANVISA, Ministry of Health

(Guidance) Inspection Guide on Good Clinical Practice (GCP) for Clinical Trials with Drugs and Biological Products - Inspection of Sponsors and Clinical Research Organization Representatives (ORPC) (GuideNo36-2020 - Portuguese) (Version 2) (Effective January 27, 2022)
ANVISA, Ministry of Health

(Document) 2020/2021 Activities Report - Coordination of Clinical Research on Medicines and Biological Products - COPEC (BRA-60 - Portuguese) (4^th Edition) (March 28, 2022)
General Management of Medicines and Biological Products (GGMED), Coordination of Clinical Research in Medicines and Biological Products (COPEC), ANVISA

(Webpage) ANVISA - Ombudsman (BRA-35 - Portuguese) (Last Updated April 6, 2022)
ANVISA, Ministry of Health