Recent News
If you are aware of any news items that would be of interest to the RQA membership, please contact the RQA office.
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EMA - Publication of Article on Real-World Evidence in EU Medicines Regulation: Enabling Use and Establishing Value
26th November 2021EMA - Publication of Article on Real-World Evidence in EU Medicines Regulation: Enabling Use and Establishing Value
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EMA - Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 3-4 November 2021
11th November 2021Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 3-4 November 2021
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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 October 2021
11th November 2021Meeting 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 2021Regulatory 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 2021Repurposing 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 2021The 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 2021Medicines: 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 2021The 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 2021International 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 2021Invitation 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 2021The 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 2021EMA 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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MHRA - launches public consultation on future of medical device regulation
27th October 2021The Medicines and Healthcare products Regulatory Agency (MHRA) is inviting members of the public to provide their views on possible changes to the regulatory framework for medical devices in the United Kingdom (UK).
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MHRA - Upcoming Board Meeting
27th October 2021The next MHRA Board meeting will take place on the 16th November. The general public can attend this virtual meeting.
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ICH - The ICH E8(R1) Guideline reaches Step 4 of the ICH Process
12th October 2021The ICH E8(R1) Guideline on General considerations for Clinical Studies reached Step 4 of the ICH Process on 6 October 2021.
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EC - Good Lay Summary Practice Guidance
7th October 2021This “Good Lay Summary Practice” (“GLSP”) provides recommendations on how to prepare, write, translate, and disseminate summaries of clinical trial results in lay language. This is a mandatory requirement laid out in Regulation (EU) No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use (“EU CTR”) and a transparency obligation to all trial participants and the interested public.
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EMA - CTIS Virtual Info Day
7th October 2021The EMA will host a CTIS virtual information day in liaison with DIA on 26th October 2021 from 13:15 to 17:00 (CET). The aim of the event is to help future CTIS users prepare for submitting and managing clinical trial applications in CTIS after its go-live on 31 January 2022.
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EMA - SAVE THE DATE: HMA/EMA Big Data Stakeholder Events
7th October 2021On behalf of the HMA-EMA joint Big Data Steering Group we are pleased to announce two upcoming stakeholder events.
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EMA - Vet Medicine Highlights Newsletter - Oct 2021
7th October 2021The latest edition of the Veterinary Medicines Regulation Highlights, which provides updates on the progress at the Agency towards implementing Regulation (EU) 2019/6, if now available.
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MHRA - MedSafetyWeek 2021
7th October 2021MHRA's sixth annual #MedSafetyWeek social media campaign will take place on 1 to 7 November 2021. .
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MHRA - Supply Chain webinar: recording now available
7th October 2021Supply Chain webinar: recording now available
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MRC - New framework on complex interventions to improve health
7th October 2021New framework on complex interventions to improve health just released.
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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 September 2021
29th September 2021Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 September 2021
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FDA - Questions and Answers on Quality Related Controlled Correspondence
29th September 2021FDA - Questions and Answers on Quality Related Controlled Correspondence
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ICH - Report of 2021 Implementation Survey available now
29th September 2021ICH - Report of 2021 Implementation Survey available now on the ICH website
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MHRA - Updated data integrity requirements for GLP Monitoring Programme members
29th September 2021Updated data integrity requirements for GLP Monitoring Programme members
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Access Consortium Strategic Plan 2021-2024
22nd September 2021Access Consortium Strategic Plan 2021-2024 published.
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EC - Targeted stakeholder consultation on the amendments to Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities
16th September 2021Targeted stakeholder consultation on the amendments to Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities
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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021
16th September 2021Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021
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EMA - Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 7-9 September 2021
16th September 2021Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 7-9 September 2021
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MHRA - Consultation on the future regulation of medical devices in the United Kingdom
16th September 2021The Medicines and Healthcare products Regulatory Agency (MHRA) is inviting members of the public to provide their views on possible changes to the regulatory framework for medical devices in the United Kingdom (UK).
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MHRA - Major milestone reached in the combined review journey
16th September 2021Major milestone reached in the combined review journey
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MHRA - Software and AI as a Medical Device Change Programme
16th September 2021Software and AI as a Medical Device Change Programme
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MHRA launches public consultation on future of medical device regulation
16th September 2021MHRA launches public consultation on future of medical device regulation
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MHRA - MHRA and US FDA tackle challenging data integrity
1st September 2021The second Medicines and Healthcare products Regulatory Agency (MHRA) and US Food and Drug Administration (FDA) joint Good Clinical Practice (GCP) symposium was held in London in February 2020.
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EMA - joint HMA/EMA Big Data Steering Group workplan
31st August 2021The joint HMA/EMA Big Data Steering Group workplan aims to increase the utility of big data in medicine regulation. A new workplan, extended to March 2023, is now available.
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MHRA - Good Pharmacovigilance Practice (GPvP) Symposium 2022
24th August 2021Help shape the event.
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EMA - Artificial intelligence in medicine regulation
17th August 2021The International Coalition of Medicines Regulatory Authorities (ICMRA) sets out recommendations to help regulators to address the challenges that the use of artificial intelligence (AI) poses for global medicines regulation, in a report published today.
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EMA - August 2021 CTIS Newsletter
17th August 2021CTIS Newsletter released
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EMA - Consultation on ICH Guideline Q13 on continuous manufacturing of drug substances and drug products - Step 2b
17th August 2021The European Medicines Agency has published for public consultation the ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Step 2b.
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EMA - PRAC Meeting Highlights 5th August 2021
17th August 2021Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August 2021
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EMA - updated Question and Answer Document on Combination Products
17th August 2021EMA publishes updated Question and Answer Document on Combination Products
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MHRA - Access Consortium strategy launched
17th August 2021MHRA Access Consortium strategy launched
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MHRA - Consultation on Early Access to Medicines Scheme (EAMS)
17th August 2021The UK Early Access to Medicines Scheme (EAMS) is one of the ways through which a patient with a life threatening or seriously debilitating condition can gain access to a medicine before it has gained approval from the UK’s medicines regulatory authority. The MHRA are seeking your views on the proposed legislative changes to clarify the legal basis for EAMS.
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MHRA - Freedom of Information responses from the MHRA: 2021
17th August 2021MHRA have released the Freedom of Information (FOI) responses for 2021.
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MHRA - Regulator seeks views on innovative medicines manufacture at point of care
17th August 2021MHRA seeks views on innovative medicines manufacture at point of care
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MHRA Blog Post - Transfer of analytical methods
17th August 2021Technical transfer of analytical methods, or analytical method transfer (AMT) is a GMP requirement for those involved in contract manufacturing and testing.
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EMA - CTIS Handbook on the website
10th August 2021The EMA Clinical Trial Information System (CTIS) Sponsor Handbook is now available on the EMA website.
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EMA - Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders
4th August 2021Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders - now available.
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BMJ - The review of the global first SARS COV 2 Human Infection Challenge studies
3rd August 2021Expert and lay members of UK RECs recognised to review Clinical Trials of Investigational Medicinal Products (CTIMPs) or Phase 1 studies in healthy volunteers, particularly those with experience of vaccine studies, were invited to join an ad hoc Research Ethics Committee to review SARS COV 2 Human Infection Challenge studies (HICS). All were asked to attend two virtual HRA workshops before the first committee meeting (and all did!) and were provided with articles from both sides of the argument for further reading. Given the pandemic lockdown, we met virtually, ensuring broad representation across the UK nations, and that applicants were easily able to attend (of huge help to our review).
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EMA - Draft IMP documents for comment
3rd August 2021'Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials' and 'Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials'.
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EMA - Six-month countdown to go-live for the Clinical Trials Information System (CTIS)
3rd August 2021The European Commission has confirmed that the entry into application of the Clinical Trials Regulation and hence the go-live date for the Clinical Trials Information System (CTIS) will be on 31 January 2022.
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WHO - GMPs for investigational products
3rd August 2021Draft working document for comments.
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NHS Health Research Authority - Combined review
2nd August 2021Information for participants who are involved in the submission of applications for Clinical Trials of Investigational Medicinal Products (CTIMPs).
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WHO - good practices for research and development facilities of pharmaceutical products
2nd August 2021DRAFT WORKING DOCUMENT FOR COMMENTS
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PIC/S - COVID-19 Risk Assessment for National Routine on-site Inspections
28th July 2021Produced by Pharmaceutical Inspection Convention - Pharmaceutical Inspection Co-Operation Scheme
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MHRA - Too good to be true? How to play your part in protecting the UK medicines supply chain
27th July 2021A new blog post from MHRA. Too good to be true? How to play your part in protecting the UK medicines supply chain
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R3: RNA, READINESS and RESPONSE
21st July 2021We need a global network of ‘living’ biofoundries. CEPI (Coalition for Epidemic Preparedness Innovations) and Wellcome Leap are collaborating on establishing a global network of ‘living’ biofoundries.
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EMA - CVMP Meeting Highlights 13-15 July
20th July 2021Meeting highlights from the Committee for Medicinal Products for Veterinary Use
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MHRA - Dr Alison Cave Starts Vital Vigilance Work
20th July 2021MHRA’s new Chief Safety Officer, Dr Alison Cave, starts vital vigilance work today
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MHRA to hold collaborative workshops with China’s medicines regulator
20th July 2021The collaboration aims to support China’s regulator in strengthening their regulatory capacity to improve patient access to safe and high-quality medicines and to promote global health security.
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EMA - CTIS Webinar
19th July 2021Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS
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EMA - Consultation on Guidelines for quality docs
19th July 2021EMA consultation: Guidelines on the requirements for quality documentation concerning medicinal products in clinical trials
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PIC/S - Document on Data Integrity
19th July 2021GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS
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EMA - Guideline on computerised systems and electronic data in clinical trials
30th June 2021RQA is collating responses to the EMA’s public consultation on the EMA “Guideline on computerised systems and electronic data in clinical trials
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EMA - Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 15-17 June 2021
30th June 2021Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 15-17 June 2021 - CVMP opinions on veterinary medicinal products
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EMA Clinical Trials Information System (CTIS) Newsletter “CTIS highlights”
30th June 2021Latest edition of the EMA Clinical Trials Information System (CTIS) Newsletter
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MHRA - £64 million funding to back UK-wide plan to strengthen clinical research delivery
30th June 2021The 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 2021Public 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 2021EMA 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 2021EMA 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 2021Regulation (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 2021Meeting 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 2021Reflection 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 2021Open Consultation - Survey
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MHRA - Updated Lists - GB Marketing Authorisations (MAs) for Centrally Authorised Products (CAPs)
16th June 2021Great 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 2021A framework for restarting NIHR research activities which have been paused due to COVID-19
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Vaccine Development Process Map
16th June 2021These two process maps were developed by the UK Vaccine R&D Network, to show key stages in both human vaccine development and veterinary vaccine development up to Phase III clinical trials or veterinary field trials. The Network is supporting vaccine R&D against some of the world's deadliest outbreak infectious diseases, and these process maps are intended to support Network members in understanding key stages in human and veterinary vaccine development and where bottlenecks could potentially delay progress.
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EC - new tools for safe exchanges of personal data
7th June 2021Today, the European Commission adopted two sets of standard contractual clauses, one for use between controllers and processors and one for the transfer of personal data to third countries.
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