Updates | ClinRegs

Canada Profile Updated in ClinRegs

Aug 6, 2021 - The Canada profile in ClinRegs has been reviewed and updated with the following information: Updated Drug Submission Application Form and Qualified Investigator Undertaking Form (See Submission Process, Trial Initiation, and Site/Investigator Selection) New guideline ...

Thailand Profile Updated in ClinRegs

Jul 22, 2021 - The Thailand profile in ClinRegs has been reviewed and updated to reflect all current regulatory requirements. Key updates include: Updated clinical trial drug importation license application submission instructions to the Thai Food and Drug Administration (Thai FDA)’s ...

UK: MHRA Announces Combined Regulatory and Ethics Review Starting in 2022

Jul 20, 2021 - On July 15, 2021, the United Kingdom’s (UK’s) Medicines and Healthcare products Regulatory Agency (MHRA) announced that starting in January 2022, all new Clinical Trials of Investigational Medicinal Products (CTIMPs) will undergo combined review from the MHRA and the UK Research Ethics ...

Uganda: NDA Issues Statement on Conduct of Clinical Trials during COVID-19

Jul 20, 2021 - The Uganda National Drug Authority (NDA) issued a statement on June 28, 2021, to sponsors and principal investigators (PIs) regarding the conduct of clinical trials during the COVID-19 lockdown. The statement notes the following: Clinical trial reviews will continue to be done remotely Researchers ...

Brazil: ANVISA Issues Service Bulletin on Expedited Clinical Trial Review

Jul 12, 2021 - The Brazil profile in ClinRegs has been updated to include Service Bulletin No. 104 - Document Analysis Procedures Required for DDCM Petitions and for Protocol Modifications that Potentially Impact Experimental Drug, Active Comparator or Placebo Quality/Safety, which ...

Australia Profile Updated in ClinRegs

Jul 7, 2021 - The Australia profile in ClinRegs has been updated to include the latest clinical trials fees information, effective July 1, 2021 through June 30, 2022. (See Regulatory Fees) ...

UK Profile Updated in ClinRegs

Jun 29, 2021 - The United Kingdom profile in ClinRegs now includes version 7.5 of the Standard Operating Procedures for Research Ethics Committees, issued by UK Health Departments’ Research Ethics Service in March 2021. No substantial edits were made to the topic areas