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News Archive

EMA publishes Draft on Quality Requirements for Combination Products

31st July 2019

The European Medicines Agency (EMA) has published a draft guideline on quality requirements for combinations of medicinal products and medical devices (so-called Drug Device Combinations - DDCs).

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Supporting medicine developers in generating quality data packages

31st July 2019

Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies): workshop report published

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OECD Update to the Principles of GLP

29th July 2019

The OECD recently released document 20 in the GLP series: Guidance Document for Receiving Authorities on the Review of the GLP Status of Non-Clinical Safety Studies.

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MHRA Update on a No Deal Brexit

26th July 2019

The Human Medicines and Medical Devices (Amendment etc.) (EU exit) Regulations 2019 was laid in UK parliament on the 24th July 2019.

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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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