Updates
Thailand Profile Updated
Jun 17, 2022 - Thailand Profile Updated
The Thailand profile in ClinRegs has been reviewed and updated with the following information:
New regulation establishing the Personal Data Protection Committee (PDPC) (See Quality, Data & Records Management)
New resources providing updated information ...
Brazil Profile Updated
May 12, 2022 - 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 ...
India Profile Updated
Apr 28, 2022 - The India profile in ClinRegs has been updated to include an amendment to the definition of “new drug” in the New Drugs and Clinical Trials Rules. (See Scope of Assessment)
Sources Added During this Update:
(Regulation) New Drugs and Clinical Trials (Amendment) Rules, 2022 (2022-CTRules-Amdt ...
Malawi Profile Updated with Latest Fees Regulations
Apr 22, 2022 - The Malawi profile in ClinRegs has been updated to include the latest Pharmacy and Medicines Regulatory Authority fees regulations. (See Regulatory Fees)
Sources Added During this Update:
(Regulation) Pharmacy and Medicines Regulatory Authority (Fees and Forms) Regulations, ...
India Profile Updated
Mar 24, 2022 - The India profile in ClinRegs has been reviewed and updated with the following information:
Requirements for obtaining consent from participants with mental illness (See Mentally Impaired)
A checklist for ethics committee re-registration (See Authorizing Body)
A link to the Institutional ...
Peru Profile Updated with Ethics Committee Registration Procedure Guidelines
Mar 23, 2022 - The Peru profile in ClinRegs has been updated to include and additional resource related to the National Institute of Health’s (Instituto Nacional de Salud (INS)) guidelines for registering ethics committees. (See Authorizing Body)
Sources Added During this Update:
(Webpage) ...
Australia Profile Updated with Governance Framework Implementation Details
Mar 10, 2022 - The Australia profile in ClinRegs has been updated to include more specific timeline information on the implementation of the National Clinical Trials Governance Framework. (See Submission Content and Timeline of Review)
Sources Revised During this Update:
(Webpage) Australian Commission ...
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