Post-authorisation Safety Studies – targeted advice from EMA

Over the past year, the European Medicines Agency (EMA) have been piloting a scheme offering advice to help improve the design of post-authorisation safety studies (PASS).  The studies collect further information on a medicine’s safety after it is placed on the market.

The pilot centred on providing advice on non-imposed PASS (category III), which are voluntary studies not required as a condition to the marketing authorisation.  Following the pilot, the EMA are encouraging MA holders to request scientific advice on PASS protocols particularly when there are complex or controversial issues or if a company proposes a new approach or methodology.

Companies can also seek scientific advice on protocols for category I and II PASS, which are imposed as part of the marketing authorisation or other agreement.  Advice on PASS can be part of a wider scientific advice request, including, for example, feedback on clinical trial design.

The EMA charges a fee for scientific advice on PASS protocols.

Please click here for further information or contact the team at Regulis.