If you are aware of any news items that would be of interest to the RQA membership, please contact the RQA office.
The MHRA GPvP inspectorate recently published their latest inspection metrics for the period from April 2017 to March 2018.
The EMA London office will close on the 1st March 2019 and re-open on the 4th March in Amsterdam....
The European Medicines Agency (EMA) will physically relocate to the Netherlands in early March 2019. The Dutch authorities have already officially handed over the temporary building, the Spark building in Amsterdam Sloterdijk, to EMA’s Executive Director Guido Rasi on 9 January 2019 and EMA is now preparing for its physical move.
MHRA Guidance on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal....
The MHRA have recently introduced a new inspector role, the Healthcare Inspector, which is currently open for applications.
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.