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Blog - MHRA Inspectorate


The pharmacovigilance systems of marketing authorisation holders are often dependent on multiple third parties; extensive outsourcing and partnering is a feature of the pharmaceutical industry as much as any other. This blog expands upon the areas identified as problematic for MAHs and service providers and provides points to consider when producing contracts and agreements text.

French GVP Update

The ANSM has published a new Q&A Document that brings important clarifications about the French requirements described in the French Good Pharmacovigilance Practices document published in February 2018.


June 2018 ICH Meetings

A number of guidance documents were adopted by the ICH Assembly at the Kobe meeting, which includes a revision of the Q&As for the Electronic Submission of Individual Case Study Reports (E2B(R3)). The MedDRA Management Committee also endorsed the first edition of the companion document to the “Points to Consider” documents.

Product Safety News

The EMA held its second public hearing in June 2018 to contribute to the review of quinolone and fluoroquinolone antibiotics and the resulting information has been published by the Agency. Following earlier recommendations by the PRAC to suspend the Marketing Authorisations, the CMDh eventually decided that HES solutions for infusion should remain on the market provided that additional measures are implemented to protect patients.

Pharmacovigilance and Inspections

The MHRA Inspectorate has updated the information on what to expect from a Pharmacovigilance Inspection and the next GCP Symposium will take place in September 2018. The French ANSM has published a new Injunction Letter over deficiencies identified during a Pharmacovigilance Inspection.

Hot topics are taken from Safety Observer Lite 147, July 2018