Updates | ClinRegs

China Profile Updated

Dec 20, 2024 - The China profile in ClinRegs has been reviewed and updated with the following information:Details from 2024 on the transfer of China’s human genetic resources (HGR) management from the Ministry of Science and Technology (MOST) to the State Council’s National Health Commission (NHC) (See ...

Mali Profile Updated

Dec 5, 2024 - The Mali profile in ClinRegs has been reviewed and updated as follows:Additional details on training requirements for members of the Institutional Ethics Committee for Health and Life Sciences Research (CIESS)/University of Sciences, Techniques and Technologies of Bamako (USTTB) (See Scope ...

DRC Profile Updated

Nov 27, 2024 - The DRC profile in ClinRegs has been reviewed and updated with the following information:Personal data protection requirements from a 2023 law (See Personal Data Protection)Supplementary Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) ...

India Profile Updated with DCGI Order Regarding Local Clinical Trial Waivers

Nov 26, 2024 - The India profile in ClinRegs has been updated to include an order issued by the Drugs Controller General of India (DCGI) specifying countries for which the DCGI may waive the requirement to conduct a local clinical trial if the new drug is already approved in one of the named countries and ...

Guinea Profile Updated

Nov 14, 2024 - The Guinea profile in ClinRegs has been reviewed and updated with the following information:Updated Ministry of Health and Public Hygiene (Ministère de la Santé et de l'Hygiène Publique (MSHP)) contact information (See Regulatory Authority)Updated National Ethics Committee for Health Research ...

Mexico Profile Updated

Nov 8, 2024 - The Mexico profile in ClinRegs has been reviewed and updated with the following information:Details for electronically submitting research protocol authorization requests via DIGIPRiS, the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS)’s Digital Research and Clinical ...

Peru Profile Updated with Additional Research Center Registration Requirements

Oct 31, 2024 - The Peru profile in ClinRegs has been updated to include the following:Requirement for the sponsor/contract research organization to ensure the research center is authorized in the specialty related to the proposed clinical trial (See Site/Investigator Selection)Requirement for research centers ...