News Archive

EMA Update - What’s new in Pharmacovigilance?

12th August 2019

The first edition of the EMA's 'What’s new in Pharmacovigilance? QPPV UPDATE' is available.

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Electronic Health Records

7th August 2019

New MHRA Blog Post on eHRs: as you will be aware, in the UK there is a national NHS initiative to replace patients’ paper medical records with electronic health records (EHRs). Although a national initiative, trusts are implementing this locally with different service providers. At several trusts this consists of scanning all written records into the EHR and destroying original source documents (both historic records and current visits).

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BP and USP MoU formalise partnership

31st July 2019

BP and USP MoU formalise partnership to strengthen quality of medicines and public health

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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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