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Blog - MHRA Inspectorate
MHRA GPvP Inspectorate Guide to Marketing Authorisation Holder Considerations for Agreements with Pharmacovigilance System Service Providers
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.

Allergen Products in the EU

The EU Authorities have launched a consultation on Regulatory Approaches for Allergen Products. The purpose is to harmonise the status of these products that may have a Marketing Authorisation in some countries whereas they may be distributed as Named Patient Products (NPP) in others, with different Pharmacovigilance requirements.

New FDA Draft Guidance

The FDA has issued two new draft guidance documents that are intended to address the gap in scientific knowledge regarding the safety of drugs and biological products during pregnancy or breastfeeding.

MHRA and GCP Serious Breaches

The MHRA Inspectorate has posted a new article on its blog, which provides information and guidance in the wake of the publication of the 2018 report on GCP Serious Breaches, most of which relate to Patient Safety.

Cobert's Manual: 3rd Edition

Cobert's Manual of Drug Safety and Pharmacovigilance is a valuable manual for those working in the field. The third edition has just been published and is now available for purchase.

Hot topics are taken from Safety Observer Lite 157, June 2019