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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.

EMA consults on 'Big Data'

The EMA has published the summary report produced by the HMA/EMA Task Force on Big Data, which provides recommendations for the use of this information in the evaluation and supervision of medicines. Stakeholders are invited to submit feedback and observations by 15-Apr-2019.

Brexit preparedness

The EMA and the CMDh have updated available guidance to help MAHs prepare for Brexit with more information to address the “no-deal Brexit” scenario. In the same manner, the UK has updated its guidance for this scenario, including new information on submission of safety information to the MHRA.

New BRA Guidance in Canada

Health Canada has issued new guidance on how to produce a Post-Market Drug Benefit-Risk Assessment for a marketed drug, when requested by the Canadian Authorities.

Product Safety News

The EMA has announced the EU-wide suspension of Fenspiride medicines while the PRAC reviews the risk of QT prolongation and torsades de pointes. Meanwhile, the FDA has concluded there is an increased risk of death with the gout treatment Febuxostat, which will be reflected in a new Boxed Warning.

Hot topics are taken from Safety Observer Lite 154, Mar 2019