EMA Finalises GVP Guideline, Fixes "Big Problem" Spotted by Danish Regulators
The European Medicines Agency (EMA) has finalised its guidelines on the collection, management, and submission of individual case safety reports (ICSR). EMA adopted the final version after going over feedback on its original draft, including the identification of a “big problem” by the Danish regulatory agency.
Drugmakers, trade groups, and regulators raised many concerns with the draft version. One of the more forcefully-worded comments came from the Danish Medicines Agency (DKMA), which pointed out what it saw as a “big problem” with the procedure for merging duplicate ICSRs.
EMA’s draft proposed to entrust marketing authorization holders (MAHs) and national competent authorities (NCAs) with the merging of duplicates. DKMA, however, foresaw problems arising if the MAH and NCA independently saw and dealt with duplicates on the same day.
The feedback from DKMA prompted EMA to change course. For the final version, EMA has revised the workflow so MAHs and NCAs inform it when they spot a duplicate. EMA will create a master case by merging the duplicates and tell the MAH and NCAs what it has done. The MAH and NCAs can then update their local databases.
That change is one of many EMA made to the guideline on good pharmacovigilance practices (GVPs). The agency also added information about managing ICSRs generated during off-label use at the request of trade group EFPIA.
EFPIA submitted one of the longer critiques of the draft and was rewarded with changes to resolve some of its criticisms. However, the final guidelines remain prescriptive, despite EFPIA criticizing the draft for being “unnecessarily specific.” EFPIA wanted EMA to give companies “some flexibility” to develop processes that drive compliance with GVPs, rather than tell them how exactly how they should handle ICSRs.
The final guideline will come into force on November 22.