News Archive

Falsified Medicines and the supply chain

13th August 2019

MHRA Blog post by Tracy Moore, 8th August.

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MHRA Update to regulations if there is a no deal Brexit

13th August 2019

Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal - Updated 8 August 2019

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Protecting Public Health - Article

13th August 2019

Dr Ian Hudson, CEO, Medicines and Healthcare products Regulatory Agency (MHRA) spoke with Viveka Roychowdhury on how the Agency is working with pharmaceutical companies to increase compliance with Good Manufacturing Practices (GMP) as well as preparing for Brexit and beyond. Read the full article.

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Updated - Blue Guide: advertising and promoting medicines

13th August 2019

Detailed guidance on advertising and promoting medicines - updated 12th August 2019.

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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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