Category Medicines Licensing

MHRA announces new regulatory recognition routes for medicines licensing using approvals from various countries

The UK MHRA has announced today that new regulatory recognition routes for medicines will be established using approvals from the following countries: This means that patients will have access to safe and effective medicines that have been approved by trusted…

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Health Canada updates guidances concerning pre and post-licensing submissions and performance standards for Post-authorization Division 1 Changes (PDCs)

Health Canada has updated guidances concerning pre and post-licensing submissions and performance standards for PDCs for prescription pharmaceutical drugs and those administered or obtained through a health professional. Notice: Revision to the Guidance Document Management of Drug Submissions and Applications…

Read MoreHealth Canada updates guidances concerning pre and post-licensing submissions and performance standards for Post-authorization Division 1 Changes (PDCs)