MHRA Brexit Update: GPvP

27th September 2019

The MHRA have released a guidance note entitled "Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders".

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Focused stakeholders consultation on revised draft PIC/S GMP Guide Annex 2A and Annex 2B

26th September 2019

A draft revision of the PIC/S GMP Guide Annex 2 (Manufacture of biological medicinal substances and products for human use) has been prepared by the PIC/S Working Group on revision of Annex 2 established with WHO, led by Francesco Cicirello, Australia / TGA, and by the PIC/S Sub-Committee on GMDP Harmonisation, led by Paul Gustafson, Health Canada.

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EMA’s work on new veterinary regulation advances

25th September 2019

EMA has launched a new webpage that shows the progress made by the Agency in the implementation of the new Veterinary Medicines Regulation (Regulation (EU) 2019/6), which becomes applicable on 28 January 2022.

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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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