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EU Pharma Revision Proposes Changes To Drug Safety Reporting

 
• By Ian Schofield

The proposed revision of the EU medicines legislation would retain the rules on safety monitoring and reporting much as they are at present, albeit with a few significant changes.

Painted hand shows concept hologram Regulation on his hand. Drawn man in business suit with future technology screen and modern cosmic background
The EU is proposing some new regulations on pharmacovigilance • Source: Shutterstock

The European Commission’s proposed reforms of the EU medicines legislation envisage a few noteworthy changes to the pharmacovigilance regulatory framework, including a relaxation of some requirements relating to generics and biosimilars and a firmer legal footing for safety data reporting on the off-label use of medicines.

Under the proposals, released on 26 April, marketing authorization holders (MAHs) would broadly retain the same pharmacovigilance obligations as at...

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