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 - 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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ABPI - ATMP Roadmap
22nd March 2022This Roadmap Tool sets out the key steps and activities in the end-to-end pathway for Advanced Therapy Medicinal Products (ATMPs) in England from non-clinical research through to treatment provision & monitoring.
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EMA - CTIS Newsflash, 18th March 2022
22nd March 2022CTIS newsflash #07 - 18 March 2022
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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16 March 2022
22nd March 2022Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16 March 2022
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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 March 2022
22nd March 2022Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 March 2022
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MHRA - Delivering High Standards in Medicines Advertising Regulation 2021 Annual Report
22nd March 2022Delivering High Standards in Medicines Advertising Regulation, 2021 Annual Report
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MHRA Webinar - Medicines Supply to Northern Ireland
22nd March 2022MHRA Webinar: Medicines Supply to Northern Ireland
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MRC announces plans to halve carbon footprint by 2030
22nd March 2022MRC announces plans to halve carbon footprint by 2030, 14th March 2022
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Safety Observer - RSI in Clinical Trials: MHRA Findings and Tips
22nd March 2022Safety Observer Article - RSI in Clinical Trials: MHRA Findings and Tips
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UKRI - Shared commitment to improve public involvement in research
22nd March 2022UK Research and Innovation (UKRI) has signed a shared commitment to improve public involvement in health and social care research.
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MHRA Blog - Compliance Monitor process (Part 1) – An introduction
16th March 2022Compliance Monitor process (Part 1) – An introduction
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EC - Political and legal issues linked to financing the development of pharmaceuticals all along their life-cycle
10th March 2022Presentations and recording - HPP webinar: “Political and legal issues linked to financing the development of pharmaceuticals all along their life-cycle” (03 March 2021)
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EMA - Regulation on EMA’s extended mandate becomes applicable
10th March 2022The regulation reinforcing EMA’s role in crisis preparedness and management of medicinal products and medical devices becomes applicable as of 1st March 2022. It puts some of the structures and processes established by EMA during the COVID-19 pandemic on a more permanent footing, while entrusting several new tasks to the Agency.
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EMA - Highlights of 2021
10th March 2022Human and Veterinary Highlights from 2021
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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 February 2022
10th March 2022Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 February 2022
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EMA - PRIME enables earlier availability of life-changing medicines
10th March 2022EMA’s PRIority Medicines (PRIME) scheme has had a positive impact on the authorisation of new medicines.
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FDA - New bill seeks to revamp FDA’s accelerated approvals programme
10th March 2022New bill seeks to revamp FDA’s accelerated approvals programme
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Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16 February 2022
10th March 2022Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16 February 2022
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MHRA - MHRA Good Practice Symposia Week (7 to 11 March 2022)
2nd March 2022MHRA Good Practice Symposia Week (7 to 11 March 2022)
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MHRA - Regulators’ experience of clinical trials during the Covid-19 pandemic (Part 3) – looking forward
2nd March 2022Blog Post - Regulators’ experience of clinical trials during the Covid-19 pandemic (Part 3) – looking forward
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MHRA - March Board Meeting and January Minutes
24th February 2022The next MHRA Board Meeting held in public will be conducted virtually by webinar on Tuesday, 15 March 2022 from 10.00 until 12.30 hrs. (GMT).
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MHRA - Q1 2022 Events
24th February 2022There are currently 5 separate events planned for March 2022.
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EMA - key recommendations in 2021 on the authorisation and safety monitoring of medicines for human use.
16th February 2022EMA has published an overview of its key recommendations in 2021 on the authorisation and safety monitoring of medicines for human use.
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EMA - CTIS Bitesize Talks
15th February 2022In 2022, EMA will offer short talks for clinical trial sponsors focused on CTIS functionalities.
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MHRA - New year, new standards for investigational medicines
15th February 2022New GMP requirements from 31 January 2022 Monday 31 January 2022 saw the Clinical Trial regulation (CTR) come into force in the European Union, and with it, the Commission guidelines on good manufacturing practice for investigational medicinal products for human use (more commonly known as the revised Annex 13 of EU GMP).
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MHRA - Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 2) – what we have learned
15th February 2022In part one of this series, we explored as an introduction how we initially responded to the Covid-19 pandemic to move faster in the set-up and approval of clinical trials. Now we look at the unprecedented challenges we faced in each area and the lessons we have learned during the last two years.
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EMA - Launch of the establishment phase of DARWIN EU® and the initiation of the Coordination Centre
10th February 2022EMA is initiating the establishment of the Coordination Centre for the Data Analysis and Real World Interrogation Network (DARWIN EU®)
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A faster path to UK trials approvals: CTIMP review service launches
9th February 2022In this joint blog, Catherine Blewett, Senior Development Manager at the HRA, and Martin O’Kane, Head of the MHRA Clinical Trials Unit, fill us in on the new process, which will lead to faster approvals.
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EMA - CTIS Now Live
9th February 2022CTIS Now Live
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EMA - New EU rules for safe and high-quality medicines for animals become effective
9th February 2022New EU rules for safe and high-quality medicines for animals become effective
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HRA - Improving information for research participants
9th February 2022Improving information for research participants - a blog by Leni Sivey
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HRA - Making transparency happen
9th February 2022Making transparency happen - a blog by Dr Naho Yamazaki, Head of Policy and Engagement
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ICH - ICH E9(R1) Estimands and Sensitivity Analysis in Clinical Trials
9th February 2022ICH E9(R1) Estimands and Sensitivity Analysis in Clinical Trials
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MHRA - E-learning modules for healthcare professionals on minimising the risks of using medicines and information on how to access medical device modules.
9th February 2022MHRA E-learning modules: medicines, updated
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MHRA - Guidance Oversight and monitoring activities
9th February 2022MHRA Guidance - Oversight and monitoring activities
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MHRA - Guidance Risk-Adapted Approach to clinical trials and Risk Assessments
9th February 2022Guidance - Risk-Adapted Approach to clinical trials and Risk Assessments
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MHRA - Public Consultation on new Clinical Trials Legislation
9th February 2022Public Consultation on new Clinical Trials Legislation
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MHRA - Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 1) – our initial response
9th February 2022Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 1) – our initial response
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EMA - Press release and press briefing on CTR/CTIS go-live
26th January 2022On 25 January 2022, the European Medicines Agency (EMA), European Commission (EC) and Heads of Medicines Agencies (HMA) published a press release and held a joint press briefing to provide an update on the application of the Clinical Trial Regulation, and the go-live of the Clinical Trials Information System (CTIS) on 31st January 2022.
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EC - Safety Assessment of Clinical Trials
25th January 2022To ensure effective and efficient safety assessment of clinical trials, the EU Commission published rules and procedures for the cooperation of the Member States. A risk-based approach should define the frequency of screening of safety information, the extent of its assessment and the timelines of assessment and reporting.
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EMA - Accelerating Clinical Trials in the EU (ACT EU): for better clinical trials that address patients’ needs - Joint Press Release
25th January 2022The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) are coming together to optimise the environment for clinical research in Europe by launching Accelerating Clinical Trials in the EU (ACT EU).
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EMA - CTIS - New Version of the Sponsor Handbook
25th January 2022Ahead of the go-live date of 31st January 2022, EMA have published a Sponsor Handbook.
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EMA - Global regulators discuss path towards regulatory alignment on response to Omicron variant
25th January 2022Global regulators discuss path towards regulatory alignment on response to Omicron variant
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EMA - Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 18-19 January 2022
25th January 2022Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 18-19 January 2022
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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 13 January 2022
25th January 2022Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 13 January 2022
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EMA - Open for Comments Guideline on the acceptability of names for human medicinal products processed through the centralised procedure
25th January 2022In December 2021, the European Medicines Agency (EMA) published the draft of the "Guideline on the acceptability of names for human medicinal products processed through the centralised procedure" for public comment on their website.
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EMA - Regulatory harmonisation of clinical trials in the EU: Clinical Trials Regulation to enter into application and new Clinical Trials Information System to be launched
25th January 2022Regulatory harmonisation of clinical trials in the EU: Clinical Trials Regulation to enter into application and new Clinical Trials Information System to be launched
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FDA - FDA publishes 2021 Year in Review
25th January 2022FDA Year in Review 2021
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MHRA Consultation on proposals for legislative changes for clinical trials
17th January 2022The MHRA are consulting on a set of proposals to improve and strengthen the UK clinical trials legislation to help make the UK the best place to research and develop safe and innovative medicines.
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REGISTRATION OPEN - EMA - Invitation to the webinar launch event for the Regulatory Science Research needs
12th January 2022Invitation to the webinar launch event for the Regulatory Science Research needs on 18 January 2022
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EMA - EMA public consultation: ICH harmonised guideline on Quality Risk Management Q9 (R1)
22nd December 2021The European Medicines Agency has published for public consultation on the ICH harmonised guideline on Quality Risk Management Q9 (R1).
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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021
21st December 2021EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021
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MHRA - Business Impact Target
21st December 2021The Medicines and Healthcare products Regulatory Agency (MHRA) assesses its regulatory impact on businesses.
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MHRA - GPvP Inspection Metrics report for April 2020 to March 2021
21st December 2021MHRA adds GPvP Inspection Metrics report for April 2020 to March 2021
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MHRA - MHRA draft guidance on randomised controlled trials generating real-world evidence to support regulatory decisions
21st December 2021In October 2020, the MHRA launched a 6-week consultation with stakeholders on the MHRA draft guidance on randomised controlled trials generating real-world evidence to support regulatory decisions. Following the consultation and an analysis of the responses received, the MHRA has published two guidance documents.
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MHRA - RWD Guidance
21st December 2021MHRA's new guidance on using real-world data to support clinical trials could get medicines to patients sooner
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EMA - CTIS Highlights Issue 6
16th December 2021EMA have just released their CTIS Highlights newsletter
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MHRA Blog - Global reflections on international inspection transformation: ICMRA remote inspections
16th December 2021Global reflections on international inspection transformation: ICMRA remote inspections
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EC - Good Lay Summary Practice
7th December 2021The European Commission (EC) has published a guideline on Good Lay Summary Practice"(GLSP). The guideline was adopted by the Clinical Trials Expert Group (CTEG) of the EU Commission, which is composed of representatives of ethics committees and national competent authorities.
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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 November - 2 December 2021
7th December 2021Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 November - 2 December 2021
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MHRA - UK PSMF
7th December 2021Additional guidance on requesting a UK PSMF number was added on 30th November 2021.
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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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