MHRA Updated NIMAR Guidance to reflect Windsor Framework

Most risk assessments are completed, signed off and never looked at again. Everyone is happy. Or are they?  On paper, this looks like compliance with ICH Q9(R1) Quality Risk Management Principles. In reality, it often misses the point entirely.  Risk assessment is...

Under the EU framework, manufacturers holding an MIA are authorised to distribute medicinal products. While there is no explicit requirement to appoint an RP in the same way as a wholesale distributor, this does not remove their obligations to ensure distribution...

For the past thirty years, Europe has built one of the world's most respected medicine regulatory systems. The centralised authorisation process has enabled groundbreaking treatments to reach millions of patients while maintaining the rigorous standards of quality,...