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News Archive
MHRA - Importing investigational medicinal products into Great Britain from approved countries from 1 January 2021
21st October 2020Sponsors of UK clinical trials that import investigational medicinal products (IMPs) into Great Britain from outside the UK will need to review their existing supply chains. Where the product is sourced from a country on the ‘approved country for import list’, this will include a UK Manufacturing and Import Authorisation (MIA(IMP)) holder putting in place an assurance system to check these IMPs have been certified by a Qualified Person (QP) in a listed country, before release to trial sites. The list of approved countries will initially include all EU and EEA countries. IMPs imported into Great Britain from outside the UK that have been QP certified in a listed country will not require recertification in Great Britain. The purpose of this guidance is to describe the principles for the management and oversight of the import of IMPs to Great Britain from listed countries. There will be a one-year transition period from 1 January 2021.
MHRA - Joins Australia-Canada-Singapore-Switzerland (ACSS) Consortium
21st October 2020The Medicines and Healthcare products Regulatory Agency (MHRA) is the latest regulator to join the Australia-Canada-Singapore-Switzerland (ACSS) Consortium.
MHRA - Supplying medicines to Northern Ireland from 1 January 2021
21st October 2020This guidance currently covers Article 41. We will update this guidance to cover all aspects of supplying medicines to Northern Ireland from 1 January 2021 in due course.
MHRA Blog Post: Expert reports - what’s expected!
21st October 2020There can be a degree of uncertainty when it comes to writing and formatting an expert report. Companies will often ask questions.
NHS R&D Forum - Save the Date
16th October 2020Two new exciting virtual events to support the health & care R&D community.
EMA - EMA’s human medicines committee (CHMP) has started the first ‘rolling review’ of a COVID-19 vaccine, which is being developed by the company AstraZeneca in collaboration with the University of Oxford
7th October 2020EMA’s human medicines committee (CHMP) has started the first ‘rolling review’ of a COVID-19 vaccine, which is being developed by the company AstraZeneca in collaboration with the University of Oxford.
EMA - Highlights of Management Board: October 2020 meeting
7th October 2020The October 2020 meeting of the Management Board focused in particular on the Agency’s activities in response to the COVID-19 pandemic. The meeting was Guido Rasi’s final Board meeting as EMA’s Executive Director before Emer Cooke takes the helm in mid-November.
EMA - New online platform for scientific advice
7th October 2020From 19 October 2020, developers of human or veterinary medicines should use EMA’s IRIS Regulatory & Scientific Information Management Platform to request scientific advice.
EMA - PRAC Meeting Highlights
7th October 2020Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 October 2020
EMA - Workshop on Support for Orphan Medicines Development
7th October 2020Workshop on Support for Orphan Medicines Development - 30 November 2020.
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