News Archive

MHRA Christmas 2019 Notifications

1st October 2019

MHRA have updated the Christmas 2019 notice period. Manufacturers are advised that MHRA will not be accepting notifications for clinical investigation or study amendments during the period 14 December 2019 – 1 January 2020 (inclusive). Any notifications received during this period will be processed in the new year and the 60 day assessment periods will start from 3 January 2020 for valid clinical investigation notifications. Any notifications received before 14 December 2019 will be processed as normal and there will be no interruption to the 60 day process over the Christmas period for these notifications.

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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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