With the recognition by the US Food and Drug Administration (FDA) of Slovakia, the European Union and the United States have now fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective territories.....
Updated Version of the Clinical Trials Regulation Questions & Answers Paper
Today, the U.S. Food and Drug Administration (FDA) issued a final guidance for industry entitled Risk Evaluation and Mitigation Strategies: Modifications and Revisions.
The United Kingdom submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union.
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).