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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EDQM - Call for experts: join the Ph. Eur. network
14th September 2022EDQM - Call for experts: join the Ph. Eur. network
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EMA - Event Summary
14th September 2022EMA - Event Summary on Workshop on the guidance on the protection of personal data and commercially confidential information (CCI) in documents submitted or uploaded via CTIS
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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 September 2022
14th September 2022EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 September 2022
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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August – 1 September 2022
14th September 2022EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August – 1 September 2022
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FDA - Computer Software Assurance for Production and Quality System Software
14th September 2022Draft Guidance has been released on Computer Software Assurance for Production and Quality System Software.
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MHRA - new conflicts of interest code of practice for independent advisors
14th September 2022MHRA - new conflicts of interest code of practice for independent advisors
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MHRA - Guidance on Medical devices: software applications (apps)
14th September 2022MHRA - Guidance on Medical devices: software applications (apps). Added - 'Appendix 4 – Field Safety Warnings and End-of-Life notification'
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MHRA - Summary of responses to consultation - new Code of Practice for the Expert Advisory Committees
14th September 2022MHRA - Summary of responses to consultation - new Code of Practice for the Expert Advisory Committees
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EMA - Comments received on ICH guideline Q14 on analytical procedure development
8th September 2022EMA have published an overview of comments received on ICH guideline Q14 on analytical procedure development
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EMA - Comments received on ICH guideline on Q2(R2) Validation of analytical procedures
8th September 2022The EMA have published an overview of the comments received for on ICH guideline on Q2(R2) Validation of analytical procedures.
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EMA - Key performance indicators (KPIs) to monitor the European clinical trials environment
31st August 2022This report provides an overview of Key Performance Indicators (KPIs) related to the implementation of the CTR. The Clinical Trials Regulation Metrics report is published on a monthly basis starting in May 2022.
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FDA - Draft Guidance on Charging for Investigational Drugs Under an IND
31st August 2022Charging for Investigational Drugs Under an IND Questions and Answers - Guidance for Industry DRAFT GUIDANCE
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EMA - Accelerating Clinical Trials in the EU: publication of 2022-2026 workplan
30th August 2022The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the PDF icon 2022-2026 workplan of the initiative Accelerating Clinical Trials in the EU (ACT EU).
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FDA - Q9(R1) Quality Risk Management (Draft Guidance Document)
30th August 2022Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries. In the pharmaceutical sector, the principles and framework of ICH Q9, coupled with the official ICH training material that supports this guideline, are instrumental in enhancing the application of effective quality risk management by industry and regulators. The importance of quality systems has been recognized in the pharmaceutical industry, and it is evident that quality risk management is a valuable component of an effective quality system.
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MHRA Blog - Innovation, Quality & Transparency – a Compliance Team 1 Perspective
30th August 2022There has been much discussion of late between regulators and industry on how we can ensure that patients and the public get new medicines as quickly as possible - all the way from development to regulatory approval - while still ensuring they are safe, effective and of the required quality.
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OECD - Advisory Document of the Working Party on Good Laboratory Practice on Quality Assurance and GLP
30th August 2022OECD - July 2022 Advisory Document of the Working Party on Good Laboratory Practice on Quality Assurance and GLP
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OECD - Position Paper on Quality Improvement Tools and GLP
30th August 2022OECD - July 2022 Position Paper on Quality Improvement Tools and GLP
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MHRA - Decommission of eSUSAR
5th August 2022The MHRA is retiring the eSUSAR website in favour for Individual Case Safety Reports (ICSR) Submissions - providing users a more robust, stringent, and transparent way of expediting suspected unexpected serious adverse drug reactions (SUSARs) from Clinical Trials of Investigational Medicinal Products.
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EDQM - Stakeholder consultation – Draft guidelines for medication review
3rd August 2022Stakeholder Consultation
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EMA - Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making
3rd August 2022EMA has endorsed a joint statement calling for international collaboration to enable the generation and use of real-world evidence for regulatory decision-making published today by the International Coalition of Medicines Regulatory Authorities (ICMRA).
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EMA - Annual Report 2021
3rd August 2022EMA release their 2021 Annual Report
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EMA - Big data use for public health: publication of Big Data Steering Group workplan 2022-25
3rd August 2022The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its PDF icon third workplan that sets key actions to be delivered between 2022–25.
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EMA - Clinical Trial Highlights Newsletter
3rd August 2022Issue 10 released July 2022
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EMA - Human Medicines Highlights Newsletter
3rd August 2022Issue 160, July 2022
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EMA - Small and Medium Business Newsletter
3rd August 2022Issue 56, July 2022
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MHRA - Medicines and Healthcare Products Regulatory Agency Annual Report and Accounts 2021 to 2022
3rd August 2022MHRA annual report and accounts 2021 to 2022.
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MHRA - New Section added to Guidance on Registering medical devices to place on the market
3rd August 2022MHRA - New Section added to Guidance on Registering medical devices to place on the market - Coronavirus Test Device Approval (CTDA) and Registering with MHRA
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MHRA - Over 285,000 medicines and medical devices seized UK-wide in global action
3rd August 2022Officers from the MHRA have seized large quantities of illegally traded medicines and medical devices in an Interpol week of action known as "Operation Pangea"
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MHRA - UK GLPMA Guidance Updates
3rd August 2022UK GLPMA Guidance on content of QA Statement 2022 and UK GLPMA Study Reporting Guidance 2022 added to Guidance on Good laboratory practice (GLP) for safety tests on chemicals
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 July 2022
3rd August 2022Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 July 2022
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EMA - Save the Date 2nd Veterinary Big Data Stakeholder Forum
20th July 2022Save the Date 2nd Veterinary Big Data Stakeholder Forum
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EMA - Good practice guidance for patient and healthcare professional organisations on the prevention of shortages of medicines for human use
18th July 2022EMA/HMA Publish 'Good practice guidance for patient and healthcare professional organisations on the prevention of shortages of medicines for human use'
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EMA - Human Medicines Highlights
18th July 2022EMA publishes Human Medicines Highlights Newsletter
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EMA - ICMRA elected Emer Cooke, Executive Director of EMA as chair for the next mandate
18th July 2022ICMRA today elected Emer Cooke, Executive Director of EMA as chair for the next mandate which starts in October 2022
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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 12-14 July 2022
18th July 2022Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 12-14 July 2022
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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 July 2022
18th July 2022Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 July 2022
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EMA - pilot project on analysis of raw data from clinical trials
18th July 2022EMA - pilot project on analysis of raw data from clinical trials
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MHRA Case Study - Horizon Scanning Case Study: Point of Care manufacture
18th July 2022Horizon Scanning Case Study: Point of Care manufacture
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The World Health Organization (WHO) and the International Digital Health and AI Research Collaborative (I-DAIR) have signed a Memorandum of Understanding (MoU)
18th July 2022The World Health Organization (WHO) and the International Digital Health and AI Research Collaborative (I-DAIR) have signed a Memorandum of Understanding (MoU)
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EMA - 2021 Annual Report
5th July 2022EMA has published its 2021 Annual Report
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EMA - Assessing dietary exposure to residues of veterinary medicines, feed additives and pesticides in food of animal origin in the EU
5th July 2022Assessing dietary exposure to residues of veterinary medicines, feed additives and pesticides in food of animal origin in the EU
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EMA - Call for companies to register their Industry Single Point of Contact (i-SPOC) on supply and availability
5th July 2022Call for companies to register their Industry Single Point of Contact (i-SPOC) on supply and availability
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EMA - Veterinary Medicines Website
5th July 2022Veterinary Medicines Website
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MHRA - Government response to consultation on the future regulation of medical devices in the United Kingdom
5th July 2022UK Government response to consultation on the future regulation of medical devices in the United Kingdom
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MHRA - Laboratories that are members of the UK GLP Compliance Monitoring Programme as of 28 June 2022
5th July 2022Laboratories that are members of the UK GLP Compliance Monitoring Programme as of 28 June 2022
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MHRA - UK to strengthen regulation of medical devices to protect patients
5th July 2022UK to strengthen regulation of medical devices to protect patients
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UK Gov - The Future of Clinical Research Delivery: 2022-2025
5th July 2022UK Gov - The Future of Clinical Research Delivery: 2022-2025 Implementation Plan
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UKRI - Why Involve the Public in Research?
5th July 2022Why involve the public in research?
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FDA - Safety Considerations for Container Labels and Carton Labelling Design to Minimise Medication Errors
30th June 2022FDA released 'Safety Considerations for Container Labels and Carton Labelling Design to Minimise Medication Errors' in May 2022.
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MHRA - MHRA joins international partnerships to set global standards for medicines and medical devices regulation
30th June 2022MHRA joins International Medical Device Regulatory Forum, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and the Medical Devices Innovation Consortium.
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EC - Q&A for Complex Clinical Trials
9th June 2022The European Commission have released a Q&A document concerning Complex Clinical Trials.
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EMA - Human Medicines Highlights Newsletter, June 2022
9th June 2022Human Medicines Highlights Newsletter, June 2022 released
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EMA - International regulators and WHO: support healthcare professionals to enhance public confidence in COVID-19 vaccines
9th June 2022International regulators and WHO: support healthcare professionals to enhance public confidence in COVID-19 vaccines EMA has endorsed a statement for healthcare professionals jointly developed by the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO). The statement is aimed to help healthcare professionals answer questions about the role of regulators in the oversight of COVID-19 vaccines and to reassure medical staff about the safety of COVID-19 vaccines that undergo a robust scientific evaluation to determine their quality, safety and efficacy.
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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 May 2022
9th June 2022Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 May 2022
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ICH - Press Release: ICH Assembly Hybrid Meeting in Athens, May 2022
9th June 2022Press Release: ICH Assembly Hybrid Meeting in Athens, May 2022
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MHRA - Board Meeting June 2022
9th June 2022MHRA Board Meeting held in public - now available to book (webinar)
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MHRA - Freedom of Information responses from the MHRA: 2022
9th June 2022MHRA - March 2022 Freedom of Information Responses from the MHRA
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MHRA - International Clinical Trials Day, 20th May 2022
9th June 2022International Clinical Trials Day
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MRC - MRC prizes 2022: Nominations are now open
9th June 2022MRC prizes 2022: Nominations are now open
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MRC - UKRI budget allocation confirmed
9th June 2022UKRI budget allocation confirmed
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Safety Observer - ANSM issues revised French GVPs
9th June 2022ANSM issues revised French GVPs
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USP - Analytical Procedures for mRNA Vaccine Quality (Draft Guidelines)
9th June 2022Analytical Procedures for mRNA Vaccine Quality (Draft Guidelines) Type of Posting: General Announcement Posting Date: 10–Feb–2022 Input Deadline: 30–Jun–2022 Expert Committee: Biologics Monograph 3 – Complex Biologics & Vaccines Proposed Title: Analytical Procedures for mRNA Vaccine Quality (Draft Guidelines)
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EMA - Gerrit Johan Schefferlie elected new Chair of EMA Committee for Veterinary Medicinal Products (CVMP)
18th May 2022EMA - Gerrit Johan Schefferlie elected new Chair of EMA Committee for Veterinary Medicinal Products (CVMP)
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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 May 2022
18th May 2022EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 May 2022
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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 May 2022
18th May 2022EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 May 2022
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EMA - Stakeholder engagement biennial report 2020-2021 and highlights of stakeholder activities in 2021
18th May 2022From the EMA Stakeholder engagement biennial report 2020-2021 and highlights of stakeholder activities in 2021 We are pleased to inform you that the biennial stakeholder engagement report has been published, along with the highlights of stakeholder activities in 2021. This report provides a high-level overview of EMA's engagement with patients, consumers, healthcare professionals and academia and different activities where they have been involved. EMA would like to thank all stakeholders involved in activities during these two challenging years. This biennial report has also been shared by social media, the links are below:
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MHRA - policy for handling conflicts of interest
18th May 2022MHRA: policy for handling conflicts of interest - Uploaded the annual conflict of interest compliance report - 2021
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MHRA - Drug Safety Update
18th May 2022MHRA - Uploaded the Drug Safety Update for May 2022
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WHO - launches first ever global report on infection prevention and control
18th May 2022WHO launches first ever global report on infection prevention and control
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MHRA Blog - Compliance Monitor Process (Part 2)– CM role and application process
11th May 2022Compliance Monitor Process (Part 2)– CM role and application process - a new blog post from the MHRA.
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EMA - CTIS newsflash #11 - 22 April 2022
4th May 2022EMA - CTIS newsflash #11 - 22 April 2022
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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2022
4th May 2022EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2022
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EMA - Overview of comments on on ICH guideline Q9 (R1) on quality risk management
4th May 2022EMA have provided an overview of comments received between December 2021 and March 2022 on on ICH guideline Q9 (R1) on quality risk management.
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MHRA - Compliance Monitor (CM) Overview and Application Process
4th May 2022From April 2022, the MHRA will be running a pilot scheme to monitor companies that fail to comply with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) and are referred to the Inspection Action Group (IAG) after an inspection that has resulted in the compliance escalation process being initiated.
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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 April 2022
19th April 2022Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 April 2022
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FDA - Request for Comments.- Cybersecurity in Medical Devices
19th April 2022FDA Request for Comments - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
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FDA/ICH - E8(R1) General Considerations for Clinical Studies
19th April 2022FDA/ICH - E8(R1) General Considerations for Clinical Studies.
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EMA - Public Consultation on the Approach of Protection of Personal data
13th April 2022The European Medicines Agency has published for public consultation a draft guidance document on how to approach the protection of personal data and commercially confidential information in documents uploaded and published in the Clinical Trial Information System (CTIS).
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ICH - Analytical Procedure Development Q14
7th April 2022ICH ANALYTICAL PROCEDURE DEVELOPMENT Q14 - Draft version
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EC - Pharmaceutical Committee 98th Meeting Minutes
6th April 2022Summary record - 98th meeting of the Pharmaceutical Committee (20 January 2022)
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EMA - Advice to sponsors on managing the impact of the war in Ukraine on clinical trials
6th April 2022Advice to sponsors on managing the impact of the war in Ukraine on clinical trials
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EMA - EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice
6th April 2022EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice
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EMA - Public Consultation ICH guideline Q14 on analytical procedure development
6th April 2022Public Consultation open on: ICH guideline Q14 on analytical procedure development
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EMA - Publication Consultation ICH guideline Q2(R2) on validation of analytical procedures for public consultation
6th April 2022The European Medicines Agency has published ICH guideline Q2(R2) on validation of analytical procedures for public consultation.
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FDA - An Acceptable Circular of Information for the Use of Human Blood and Blood Components
6th April 2022In March FDA published 'An Acceptable Circular of Information for the Use of Human Blood and Blood Components' - Guidance for Industry
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MHRA - Updated email address for Scientific Advice
6th April 2022Medicines: get scientific advice from MHRA - New Email Address
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