News Archive

MHRA Register of Written Confirmations For UK Active Substance Manufacturers

25th September 2019

Updated 24th September 2019.

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Fda Issues Guidance for Industry on Wholesale Distributor Verification Requirement for Saleable Returned Drug Product

24th September 2019

On the 23rd September, FDA announced the availability of a final guidance for industry entitled "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product--Compliance Policy."

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Dr June Raine has become interim Chief Executive of the MHRA

23rd September 2019

Today the Medicines and Healthcare products Regulatory Agency (MHRA) welcomes Dr June Raine as its interim Chief Executive.

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MHRA Update to a No-Deal Brexit - Medical Devices

19th September 2019

The MHRA have updated their advice in the event of a no-deal Brexit. This update relates to the UK Responsible Person section.

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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC)

11th September 2019

Includes agenda and Sept 2019 PRAC statistics

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MHRA: Brexit No-Deal Update

9th September 2019

The MHRA have updated their guidelines on how you can continue to submit regulatory and notification information to the UK.

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EMA publishes first two Guidances on Drug Shortages

4th September 2019

Regulators in the European Union have taken first steps to diminish shortages of medicinal products. The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published two guidance documents which can be seen as foundation or first step for a long way: how to define and how to communicate drug shortages.

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Global public meeting on draft ICH guideline on clinical trials

4th September 2019

The global guidance for the conduct of clinical trials is currently undergoing a major revision. As part of the worldwide consultation process, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is organising a public meeting to review its draft E8 (R1) Guideline ‘General Considerations for Clinical Trials’. EMA is encouraging its stakeholders to register for this meeting, which will be held on 31 October 2019 at the United States Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland, United States of America. Participants will be able to attend in person or via webcast.

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EMA/FDA analysis - Alignment of Decisions

21st August 2019

EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US.

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Questions and Answers on Current GMP—Laboratory Controls

21st August 2019

The FDA has recently added three new questions to its Q&A section on cGMP in the Quality Control Laboratory (chromatography systems and describe FDA's perception of basic cGMP principles in chromatographic procedures).

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