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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.