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EU and US reach a milestone....

15th July 2019

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.....

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Updated Version of the Clinical Trials Regulation Questions & Answers Paper

11th July 2019

Updated Version of the Clinical Trials Regulation Questions & Answers Paper

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GPvP - FDA issues final guidance for Industry on Risk Evaluation and Mitigation Strategies: Modifications and Revisions

10th July 2019

Today, the U.S. Food and Drug Administration (FDA) issued a final guidance for industry entitled Risk Evaluation and Mitigation Strategies: Modifications and Revisions.

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European Commission - Withdrawal of the UK and EU rules in the field of GLP

1st July 2019

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.

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MHRA public consultation on its plans to apply analytical quality by design (AQbD) principles to its Pharmacopoeia

12th June 2019

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.

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MHRA - GCP Serious Breaches - the 2018 Edition

3rd June 2019

MHRA's GCP Serious Breaches metrics and examples have been released.

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GOOD STORAGE AND DISTRIBUTION PRACTICES

29th May 2019

WHO Document for Consultation GOOD STORAGE AND DISTRIBUTION PRACTICES

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MHRA STEM Minutes

29th May 2019

Minutes and presentations now available.

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Brexit: EU supports pharmaceutical Companies

6th March 2019

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.

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Brexit: Handling PV Data from the UK

6th March 2019

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).

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