EMA Public Engagement Highlights of 2018

25th July 2019

The EMA recently shared the highlights of patient, consumer, healthcare professional and academia involvement in our activities in 2018 with the RQA.

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CVMP meeting, 16-18 July 2019

24th July 2019

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 July 2019

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EMA takes note of the European Ombudsman’s decision on pre-submission activities

24th July 2019

EMA welcomes the European Ombudsman’s recognition of the value and need for scientific advice and her recommendations are in line with EMA’s ongoing initiatives to further increase transparency.

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Government to invest £16m in ‘life-saving’ medical advances

24th July 2019

The Government has announced the decision to invest around £16 million in various ‘life-saving’ medical advances, including improved diagnosis and treatment for cancer and heart disease.

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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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