Covering Good Clinical Practice, Good Distribution Practice, Good Laboratory Practice, Good Manufacturing Practice and Good Pharmacovigilance Practice, there has been significant stakeholder interest in the development of the guide. MHRA received over 1300 comments from industry, and trade and professional groups across all GxPs during the consultation process. Such a high degree of engagement required an extended period of review by the MHRA’s GxP data integrity team formed from their GCP, GDP, GLP, GMP and GPvP inspection groups. The GxP data integrity guidance has a high degree of alignment with documents published by other regulators such as PIC/S, WHO, OECD (guidance and advisory documents on GLP) and EMA. It is designed to facilitate compliance through education, whilst clarifying the MHRA’s position on data integrity and the minimum expectation to achieve compliance.
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. The range of activities spans individuals providing ad hoc advice to the outsourcing of the entire suite of critical pharmacovigilance processes and governance roles via licensing or marketing authorisation holder partners, vendors for services or tools, and individual contractors. Whilst the majority of service providers offer a valuable and compliant support to marketing authorisations holders, the MHRA GPvP Inspectorate experience is that marketing authorisation holders do not always include adequate text in written agreements to allow management of the outsourced activities and the risk of serious pharmacovigilance failures.
An update from the Medicines and Healthcare products Regulatory Agency (MHRA) to pharmaceutical companies on preparations for exiting the European Union
A roundup of links on the EMA relocation decision can be found here.