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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.

Brexit preparedness

The EMA will further scale back activities due to staff loss caused by its relocation, and the Agency is concerned about the risks of supply shortages in the EU. The UK appears confident that no change will become effective until the end of an implementation period, which however remains subject to the terms of the final Withdrawal Agreement.

Additional information was published to highlight the possible consequences of a “no-deal Brexit”.

EudraVigilance and MAH obligations

The EMA has published guidance to clarify the obligations of MAHs to record information on ICSRs they can access in EudraVigilance, which concerns both ICSRs submitted by other MAHs and ICSRs available in EudraVigilance prior to the implementation of the new system on 22-Nov-2017.

EU Clinical Trial Safety

The European Commission has launched a new consultation on the draft GCP Guidelines for Advanced Therapy Medicinal Products (ATMPs). The EMA has also issued a Draft Questions and Answers document on Data Monitoring Committees issues.

FDA Draft Guidance

The FDA has issued a new draft guidance on Long Term Follow-Up for Gene Therapy Products. The FDA has also reopened the comment period for its draft guidance on “Development of a Shared System REMS”.

Hot topics are taken from Safety Observer Lite 148, Sept 2018