News Archive

MHRA - £64 million funding to back UK-wide plan to strengthen clinical research delivery

30th June 2021

The implementation plan published on 23rd June 2021 sets out the first year of activities towards delivering the vision for The Future of UK Clinical Research Delivery.

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PIC/S Adapting EU GMP Annex 16 on Authorised Person and Batch Release

23rd June 2021

Public consultation Following several internal rounds of consultation and extensive discussion between PIC/S Members on draft versions of PIC/S Annex 16, the PIC/S Committee recently agreed to proceed to Step 2 of the PIC/S consultation process.

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EMA - 2020 Annual Report

16th June 2021

EMA has published its 2020 annual report that provides an overview of the Agency’s major achievements and contributions to public health in Europe.

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EMA - Data Analysis and Real World Interrogation Network (DARWIN EU)

16th June 2021

EMA is establishing a coordination centre to provide timely and reliable evidence on the use, safety and effectiveness of medicines and vaccines, from real world healthcare databases across the EU. The initiative is called Data Analysis and Real World Interrogation Network, or simply #DARWINEU. It will connect the European medicines regulatory network to the European Commission's European Health Data Space (EHDS), an initiative to promote better exchange and access to different types of health data. DARWIN EU will enable EMA and national competent authorities in the European medicines regulatory network to draw on valid and reliable evidence whenever needed throughout the lifecycle of a medicinal product.

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EMA - Medical Device Regulation comes into application

16th June 2021

Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May 2021.

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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2021

16th June 2021

Meeting highlights for PRAC held 7th - 10th June 2021

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EMA - Reflection paper on forecasting demand for medicinal products in the EU/EEA

16th June 2021

Reflection paper on forecasting demand for medicinal products in the EU/EEA Published 3rd June 2021

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MHRA - MHRA Patient Involvement Strategy consultation

16th June 2021

Open Consultation - Survey

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MHRA - Updated Lists - GB Marketing Authorisations (MAs) for Centrally Authorised Products (CAPs)

16th June 2021

Great Britain Marketing Authorisations (MAs) for Centrally Authorised Products (CAPs) An updated list of PLGB numbers for the grandfathering of CAP MAs.

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NIHR - Restart Framework

16th June 2021

A framework for restarting NIHR research activities which have been paused due to COVID-19

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