New Pharmacovigilance Inspectors Group releases priorities
Focus on anticipated queries to prepare for inspections and harmonising pharmacovigilance probes
The new EU Pharmacovigilance Inspectors Working Group has released a detailed action plan spelling out how it will achieve its goal of harmonising and co-ordinating EU medicine checks.
Established by the European Medicines Agency (EMA) in October 2009, the working group has prioritised the need to work on anticipated pre-defined queries to prepare for inspections. At the same time, it will prepare procedures and processes ensuring pharmacovigilance probes staged across the EU are harmonised and their results recognised in all member states.
For instance, the paper said the group would ‘work jointly with assessors to identify triggers for inspection and to improve processes for inspection follow-up’. It would also develop international co-operation in pharmacovigilance (PhV) inspection; help train inspectors and assessors; and prepare good practice guidance for these investigations.
Looking ahead, the action plan explained how the group would harmonise PhV checks for EU central market approval procedures. This would include devising guidelines on communicating inspection findings; on following up these inquiries; and staging investigations if concerns emerged about previously approved medicines.
The working group is to release an annual programme of routine PhV inspections, which will focus on medicines with EU-wide approval, although it will also sometimes assess drugs with national authorisations.
Meanwhile, the group spelt out in detail how it intended to work with the European Commission, including recommending new EU regulations on pharmacovigilance. The plan stressed that the working group would also work with other wings of EMA, the World Health Organisation (WHO) and other global pharmaceutical industry bodies.