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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.

New Eudralex Volume 10

The European Commission website has been revised to include a new section in Eudralex Volume 10, which presents the guidelines that will be applicable to Clinical Trials authorised under the New Regulation (EU) No 536/2014.

EU Q&As on RSI in Clinical Trials

As reported earlier, the EU Heads of Medicines Agencies have published a new version of the “Questions and Answers – Reference Safety Information (RSI)”. In a new Cover Note, the Clinical Trials Facilitation Group (CTFG) sets a 1-year transition period until Competent Authorities enforce the new requirements more strictly from 01-Jan-2019.

EMA Good Pharmacogenomic Practice

Following a consultation in May 2016, the EMA has now published the adopted Guideline on Good Pharmacogenomic Practice, which will enter into effect on 01-Sep-2018.

New EudraVigilance System

The EMA has published updated information and guidance related to the new EudraVigilance System. This includes a revised version of the Questions and Answers document on the launch of the new EudraVigilance system.

FDA Reporting & Combination Products

The FDA has issued a “Compliance Policy” that delays the enforcement of some provisions of the December 2016 final rule describing postmarketing safety reporting requirements for combination products. In addition, the FDA has published for comments a Draft Guidance to support compliance with the final rule.

Hot topics are taken from Safety Observer Lite 144, April 2018