The 1,500 th study was registered in the EU PAS (Post-Authorisation Studies) Register in April 2019 1 . Following launch of the register in November 2010, it took over 2 years for the first 100 studies to be uploaded 2 , but it is now common for >200 studies to be registered each year 3 . The...
Results of a previous survey conducted by the EMA showed that 90% of initial MAAs are affected by validation issues. In order to address this, the Agency is now requesting that Applicants include a new validation checklist as part of the MAA dossier. Use of this checklist should help ensure a...
The MHRA has recently published a guidance for handling of centrally authorised products (CAPs) with assessment pending on EU exit day. Although the document is concerned with a no-deal scenario, it may also provide an accurate framework in the event of an ordered Brexit, depending on the exact...
BREXIT: Procedural Updates for Type I EMA variations The EMA is strongly encouraging MAHs to be prepared for Brexit to occur by the 12th of April 2019. In particular, the Agency is requesting that Type I variations are submitted ASAP in order to guarantee that they are validated on time, as the...
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