Quality in 510(k) 'Quik' Review Programme Pilot The FDA has launched the Quality in 510(k) ('Quik') Review Programme pilot. The goal of this pilot is to simplify how manufacturers of certain moderate risk medical devices complete a premarket notification (510(k)) submission, and to evaluate whether use of the FDA’s free eSubmitter software will result in well-organised submissions that can be reviewed more efficiently.
According to the European Medicines Agency (EMA), marketing authorisation holders (MAHs), applicants and sponsors of centrally authorised medicines for human or veterinary use should consider how Brexit will impact their medicines and which changes need to be addressed before the UK leaves the EU. They also need to ensure that the necessary changes are made by that date.
The British Government has issued technical information on what the implementation period means for the life science sector. This includes details on how the EU’s new Clinical Trials Regulation (CTR) will be approached by the UK.
From 18 June 2018 the Agency moved out of its Victoria location to a new, modern office in Canary Wharf. The relocation follows the establishment in 2016, announced by the Cabinet Office, of a new Government Hub for more than 5,000 civil and public servants in East London.
The European Medicines Agency (EMA) and the European Commission have updated their guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU).
Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice.
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.