MHRA Updated NIMAR Guidance to reflect Windsor Framework

ICH M4Q(R2): What the New CTD Quality Structure Means for the Pharmaceutical Industry  The proposed revision of ICH M4Q(R2) represents one of the most significant changes to the Common Technical Document (CTD) Quality Module since its introduction in 2002. While the...

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...