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EDQM - Call for experts: join the Ph. Eur. network
EMA - 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
EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 September 2022
EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August – 1 September 2022
Draft Guidance has been released on Computer Software Assurance for Production and Quality System Software.
MHRA - new conflicts of interest code of practice for independent advisors
MHRA - Guidance on Medical devices: software applications (apps). Added - 'Appendix 4 – Field Safety Warnings and End-of-Life notification'
MHRA - Summary of responses to consultation - new Code of Practice for the Expert Advisory Committees
EMA have published an overview of comments received on ICH guideline Q14 on analytical procedure development
The EMA have published an overview of the comments received for on ICH guideline on Q2(R2) Validation of analytical procedures.
This 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.
Charging for Investigational Drugs Under an IND Questions and Answers - Guidance for Industry DRAFT GUIDANCE
The 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).
Risk 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.
There 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.
OECD - July 2022 Advisory Document of the Working Party on Good Laboratory Practice on Quality Assurance and GLP
OECD - July 2022 Position Paper on Quality Improvement Tools and GLP
The 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.
EMA 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).
EMA release their 2021 Annual Report
The 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.
Issue 10 released July 2022
Issue 160, July 2022
Issue 56, July 2022
MHRA annual report and accounts 2021 to 2022.
MHRA - New Section added to Guidance on Registering medical devices to place on the market - Coronavirus Test Device Approval (CTDA) and Registering with MHRA
Officers from the MHRA have seized large quantities of illegally traded medicines and medical devices in an Interpol week of action known as "Operation Pangea"
UK 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
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 July 2022
Save the Date 2nd Veterinary Big Data Stakeholder Forum
EMA/HMA Publish 'Good practice guidance for patient and healthcare professional organisations on the prevention of shortages of medicines for human use'
EMA publishes Human Medicines Highlights Newsletter
ICMRA today elected Emer Cooke, Executive Director of EMA as chair for the next mandate which starts in October 2022
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 12-14 July 2022
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 July 2022
EMA - pilot project on analysis of raw data from clinical trials
Horizon Scanning Case Study: Point of Care manufacture
The World Health Organization (WHO) and the International Digital Health and AI Research Collaborative (I-DAIR) have signed a Memorandum of Understanding (MoU)
EMA has published its 2021 Annual Report
Assessing dietary exposure to residues of veterinary medicines, feed additives and pesticides in food of animal origin in the EU
Call for companies to register their Industry Single Point of Contact (i-SPOC) on supply and availability
Veterinary Medicines Website
UK Government response to consultation on the future regulation of medical devices in the United Kingdom
Laboratories that are members of the UK GLP Compliance Monitoring Programme as of 28 June 2022
UK to strengthen regulation of medical devices to protect patients
UK Gov - The Future of Clinical Research Delivery: 2022-2025 Implementation Plan
Why involve the public in research?
FDA released 'Safety Considerations for Container Labels and Carton Labelling Design to Minimise Medication Errors' in May 2022.
MHRA 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.
The European Commission have released a Q&A document concerning Complex Clinical Trials.
Human Medicines Highlights Newsletter, June 2022 released
International 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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 May 2022
Press Release: ICH Assembly Hybrid Meeting in Athens, May 2022
MHRA Board Meeting held in public - now available to book (webinar)
MHRA - March 2022 Freedom of Information Responses from the MHRA
International Clinical Trials Day
MRC prizes 2022: Nominations are now open
UKRI budget allocation confirmed
ANSM issues revised French GVPs
Analytical 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)
EMA - Gerrit Johan Schefferlie elected new Chair of EMA Committee for Veterinary Medicinal Products (CVMP)
EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 May 2022
EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 May 2022
From 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:
MHRA: policy for handling conflicts of interest - Uploaded the annual conflict of interest compliance report - 2021
MHRA - Uploaded the Drug Safety Update for May 2022
WHO launches first ever global report on infection prevention and control
Compliance Monitor Process (Part 2)– CM role and application process - a new blog post from the MHRA.
EMA - CTIS newsflash #11 - 22 April 2022
EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2022
EMA have provided an overview of comments received between December 2021 and March 2022 on on ICH guideline Q9 (R1) on quality risk management.
From 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.
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 April 2022
FDA Request for Comments - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
FDA/ICH - E8(R1) General Considerations for Clinical Studies.
The 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).
ICH ANALYTICAL PROCEDURE DEVELOPMENT Q14 - Draft version
Summary record - 98th meeting of the Pharmaceutical Committee (20 January 2022)
Advice to sponsors on managing the impact of the war in Ukraine on clinical trials
EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice
Public Consultation open on: ICH guideline Q14 on analytical procedure development
The European Medicines Agency has published ICH guideline Q2(R2) on validation of analytical procedures for public consultation.
In March FDA published 'An Acceptable Circular of Information for the Use of Human Blood and Blood Components' - Guidance for Industry
Medicines: get scientific advice from MHRA - New Email Address