Updates
South Africa Profile Updated in ClinRegs
May 27, 2021 - The South Africa profile in ClinRegs has been reviewed and updated to include the following:
Updated information on the South African Health Products Regulatory Authority (SAHPRA) (See Regulatory Authority)
Updated information on clinical trial fees and payment instructions (See ...
Uganda Profile Reviewed
Apr 29, 2021 - The Uganda profile in ClinRegs has been reviewed. All information is up-to-date and accurate.
Should any of Uganda's requirements undergo revision, we will make the corresponding updates in ClinRegs and notify you promptly.
UK Profile Updated in ClinRegs
Apr 23, 2021 - The United Kingdom profile in ClinRegs has been reviewed and updated to reflect new and updated requirements following the Brexit transition period including:
UK General Data Protection Regulation (UK GDPR) (effective January 1, 2021): includes the same ...
India Profile Updated in ClinRegs
Mar 26, 2021 - The India profile in ClinRegs has been reviewed and updated to reflect current requirements. Key updates include:
Expanded information on the terms of reference the Central Drugs Standard Control Organization (CDSCO) uses to constitute Subject Expert Committees which ...
Mali Profile Updated in ClinRegs
Mar 18, 2021 - The Mali profile in ClinRegs has been updated to include information on the Institut National de Santé Publique (INSP)’s ethics committee (EC), which is now fully operational. For a list of the INSP EC members and more details about the committee’s responsibilities, ...
Kenya Profile Updated in ClinRegs
Mar 9, 2021 - The Kenya profile in ClinRegs has been updated to include the following information:
Guidelines on Research Licensing and Institutional Affiliation: A National Commission for Science, Technology, and Innovation (NACOSTI) guidance for submitting research license applications, ...
Brazil: ANVISA Issues Notice on Safety Reporting and COVID-19 Clinical Trials
Feb 18, 2021 - On February 11, 2021, Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) issued a notice stating that, due to some instabilities with the online NotivsaEC form, sponsors must also email notifications of unexpected serious adverse ...
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