Updates | ClinRegs

United Kingdom: MHRA Issues Guidance for Clinical Trials Post-Brexit Transition Period

Sep 1, 2020 - On September 1, 2020, the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) issued the following guidance documents related to clinical trials after the Brexit transition period ends on December 31, 2020: Registration of clinical trials for investigational ...

Uganda: UNCST Issues Guidelines for Research during COVID-19 Pandemic

Aug 28, 2020 - The Uganda National Council for Science and Technology (UNCST) has issued the National Guidelines for Conduct of Research during Coronavirus Disease 2019 (COVID-19) Pandemic. The guidance aims to assist researchers with complying with COVID-19 prevention and management measures, protecting ...

Thailand Profile Updated in ClinRegs

Aug 27, 2020 - The Thailand profile in ClinRegs has been reviewed and updated to reflect current regulatory requirements. Key updates include: Expanded clinical trial review and approval process information, including electronic submission to the Thai Food and Drug Administration ...

DRC Profile Reviewed

Aug 27, 2020 - The Democratic Republic of Congo (DRC) profile in ClinRegs has been reviewed. All information is up-to-date and accurate. Should any DRC requirements undergo revision, we will make the corresponding updates in ClinRegs and notify you promptly.

Canada Profile Updated in ClinRegs

Aug 20, 2020 - The Canada profile in ClinRegs now includes the following updates: Updates to Health Canada contact information (See Regulatory Authority) New information on the Research Ethics Board Attestation (See Scope of Review) Revised versions of the Clinical Trial ...

Malawi Profile Reviewed

Aug 20, 2020 - The Malawi profile in ClinRegs has been reviewed. All information is up-to-date and accurate. Please note that the Pharmacy and Medicines Regulatory Authority (PMRA) now replaces the former Pharmacy, Medicines & Poisons Board (PMPB). At the time of the profile ...

New Requirements Issued by China's NMPA

Aug 18, 2020 - China’s National Medical Products Administration (NMPA) has recently released the following requirements, which the ClinRegs team is reviewing and will incorporate into the China profile this year. Drug Clinical Trial Registration and Information Disclosure Management (No. ...