Updates | ClinRegs

India Profile Updated in ClinRegs

Apr 1, 2020 - The India profile in ClinRegs has been reviewed and updated to reflect current regulatory requirements. Key updates include: Additional checklists and FAQs issued by the Central Drugs Standard Control Organization (CDSCO) to facilitate the clinical trial application ...

Peru: INS Issues Communications for Clinical Trials Impacted by COVID-19

Apr 1, 2020 - Due to the COVID-19 outbreak, Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) has issued the following communications: Communique 003-2020-OGITT/INS regarding the current suspension of administrative procedures until further notice and the prioritization ...

South Africa: SAHPRA Issues Guidance for Clinical Trials Impacted by COVID-19

Mar 27, 2020 - On March 25, 2020, the South African Health Products Regulatory Authority (SAHPRA) issued SAHPRA Policy on Conduct of Clinical Trials of Health Products during the Current COVID-19 Pandemic. The guidance covers items such as participant safety, maintaining compliance with good clinical ...

Health Canada Issues Notice for Clinical Trials Impacted by COVID-19

Mar 24, 2020 - On March 23, 2020, Health Canada issued Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors, which provides information related to protocol deviation, participant safety, site monitoring, participant eligibility, pausing a study, and shipment of ...

Australia: Health Agencies Issue Joint Guidance Regarding Clinical Trials and COVID-19

Mar 24, 2020 - On March 24, 2020, Australia’s state and territory Departments of Health, the Therapeutic Goods Administration (TGA), National Health and Medical Research Council (NHMRC) and the Clinical Trials Project Reference Group (CTPRG) issued: COVID-19: Guidance on clinical trials for institutions, ...

UK Profile Updated in ClinRegs

Mar 20, 2020 - The United Kingdom (UK) profile in ClinRegs has been reviewed and updated with the following: Updated information on the UK’s withdrawal from the European Union and its impact on clinical research (See Scope of Assessment) Updated information on electronic communication ...

United States: FDA and NIH Issue Guidance for Clinical Trials Impacted by COVID-19

Mar 18, 2020 - FDA and NIH Issue Guidance for Clinical Trials Impacted by COVID-19 On March 18, 2020, the Food & Drug Administration (FDA) issued FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic to assist sponsors in assuring the safety of trial participants, ...