News Archive

EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 October 2021

11th November 2021

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 October 2021

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EMA - Regulatory update - EMA encourages companies to submit type I variations for 2021 in November 2021

11th November 2021

Regulatory update - EMA encourages companies to submit type I variations for 2021 in November 2021

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EMA - Repurposing of authorised medicines: pilot to support not-for-profit organisations and academia

11th November 2021

Repurposing of authorised medicines: pilot to support not-for-profit organisations and academia

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MHRA - GLPMA Stakeholder Meeting Minutes May 2021

11th November 2021

The UK GLPMA hold periodic meetings with stakeholders. The minutes of the last meeting can be found here UK GLPMA Consultative committee meeting minutes May 2021

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MHRA - Medicines: licensing time-based performance measures

11th November 2021

Medicines: licensing time-based performance measures

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PIC/S Concept Papers on the revision of EU-PIC/S GMP Annexes 4 & 5

11th November 2021

The PIC/S Working Group on Veterinary Medicinal Products (VMP), led by Grégory Verdier (France / ANSES), and the EMA GMP/GDP Inspectors Working Group have jointly developed two concept papers on the revision of Annex 4 (manufacture of veterinary medicinal products other than immunologicals) and Annex 5 (manufacture of immunological veterinary medicinal products) of the EU-PIC/S GMP Guide.

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WHO - International organisations, vaccine manufacturers take stock of COVID-19 vaccine roll out, share views for 2022

11th November 2021

International organisations, vaccine manufacturers take stock of COVID-19 vaccine roll out, share views for 2022

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EMA - Invitation to the 4th public stakeholder meeting on COVID-19 therapeutics and vaccines in the EU

4th November 2021

Invitation to the 4th public stakeholder meeting on COVID-19 therapeutics and vaccines in the EU

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MHRA - First oral antiviral for COVID-19, Lagevrio (molnupiravir), approved by MHRA

4th November 2021

The antiviral was found to be safe and effective following a stringent review of the available evidence.

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EMA - Generating high-quality evidence from registry-based studies

27th October 2021

EMA has published guidance to provide key methods and good regulatory practices to pharmaceutical organisations on the planning and conduct of registry-based studies.

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