If you are aware of any news items that would be of interest to the RQA membership, please contact the RQA office.
The MHRA opened a three-month public consultation (until August 31, 2019) on its plans to apply analytical quality by design (AQbD) principles to its pharmacopoeia.
MHRA's GCP Serious Breaches metrics and examples have been released.
WHO Document for Consultation GOOD STORAGE AND DISTRIBUTION PRACTICES
Minutes and presentations now available.
Medicinal products imported into the EU must undergo batch testing within the EU and the European Economic Area (EEA)*. Once the United Kingdom (UK) leaves the EU (Brexit), pharmaceutical manufacturers who have previously carried out batch testing in the UK must relocate their batch testing operations to the EU/EEA in order to import their products.
The European Medicines Agency (EMA) has updated the agency's Brexit-related guidance documents. This guidance is supporting pharmaceutical companies to prepare for the United Kingdom's (UK) withdrawal from the European Union (EU). Now the 'Questions and Answers' document has been updated (Rev 04, published on 1st February 2019). The new Q&As address the situation when the United Kingdom becomes a third country on 30th March 2019 without a withdrawal agreement (and hence without a transition period).
The European Medicines Agency (EMA) and the European Commission are providing guidance to help pharmaceutical companies responsible for both human and veterinary medicines prepare for the United Kingdom's (UK) withdrawal from the European Union (EU), a process known as 'Brexit'.
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....