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EMA - Progress with EU-US mutual recognition agreement for inspections for veterinary medicines
7th June 2023On 31 May 2023, the European Union and the United States have made important progress towards enabling mutual recognition of inspections of manufacturing facilities of certain veterinary products.
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EMA - Veterinary Medicines Highlights Newsletter
7th June 2023News, activities and interviews from the Veterinary Medicines Division. Published quarterly by the European Medicines Agency.
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EMA - CTIS Newsflash -26 May 23
31st May 2023This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
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MHRA - New regulatory pathway set to support safe patient access to innovative medical technologies
31st May 2023Set for launch later in 2023, the Innovative Devices Access Pathway (IDAP) will be run by the MHRA, NICE, and other partners, including the devolved administrations.
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MHRA - new recognition routes
31st May 2023MHRA announces new recognition routes to facilitate safe access to new medicines with seven international partners
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MHRA - changes to the ICH E6 GCP Guideline
29th May 2023Andrew Fisher, Lead Senior GCP Inspector, writes a blog about the recent changes.
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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16 May 2023
25th May 2023CVMP opinions on veterinary medicinal products
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FDA - Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products Guidance for Industry
25th May 2023This guidance describes FDA’s current recommendations regarding adjusting for covariates in the statistical analysis of randomized clinical trials in drug2 development programs. This guidance provides recommendations for the use of covariates in the analysis of randomized, parallel group clinical trials that are applicable to both superiority trials and noninferiority trials.
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FDA - Discussion Paper: Artificial Intelligence in Drug Manufacturing
25th May 2023As FDA considers the application of its risk-based regulatory framework to the use of AI technologies in drug manufacturing, the Agency has identified in this discussion paper areas for which public feedback would be valuable.
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FDA - Guidance Snapshots/Podcasts highlight the agency’s commitment to improve the diversity of participants in clinical trials
25th May 2023The FDA have published two Guidance Snapshots accompanied by two Guidance Recap Podcasts to highlight the agency’s commitment to improve the diversity of participants in clinical trials, and to increase awareness of the agency’s 2020 guidance, Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs, which presents recommendations sponsors can apply to diversify participation in clinical trials.
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WHO - WHO issues urgent call for global climate action to create resilient and sustainable health systems
25th May 2023Today (24th May) at the World Health Organization (WHO), panelists made an impassioned plea for urgent climate action as it hosted a Strategic Roundtable on the Role of the Health Communities in Climate Action: taking stock and moving forward at the World Health Assembly.
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ICH - ICH E6(R3) Principles, Annex 1 and Annex 2
23rd May 2023ICH-E6(R3): An Important Global Good Clinical Practice Standards - Available for Public Input.
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EMA - Annual report 2022 published
17th May 2023EMA published its annual report 2022 on 15th May 2023. The report provides an overview of the Agency’s activities to protect and promote public and animal health in the European Union (EU).
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EMA - 3-year work plan for the Quality domain
17th May 2023The GMDP IWG 3-year workplan is developed with a focus on the Network Strategy and Regulatory Science Strategy (RSS) goals, with a particular emphasis on supply chain integrity and resilience, product quality and the impact of new manufacturing technologies on the supply chain.
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EMA - CTIS newsflash – 12 May 2023
17th May 2023This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
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EMA - Human Medicines Highlights Newsletter 169
17th May 2023Edition 169
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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 12 May 2023
17th May 2023Highlights from 10 - 12 May 2023 meeting
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EMA - eAF-PMS NEWSLETTER 3
17th May 2023News, views and interviews for the informed stakeholder. Published four times a year by the European Medicines Agency
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EMA - recommendations for industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact
17th May 2023EMA has published recommendations for industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact. Medicine shortages are a global health problem and are increasingly affecting European countries. Shortages can lead to medicine rationing and delay in critical treatments, with a significant impact on patient care. In addition, patients may need to use less effective alternatives and face an increased risk of medication errors. Ensuring the availability of authorised medicines in the European Union (EU) is a key priority for EMA and the European medicines regulatory network.
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MHRA - Medical device stand-alone software including apps
17th May 2023MHRA have updated 'Medical device stand-alone software including apps' to include information on the implementation of new regulations, updates to various links including MORE and new software vigilance guidance.
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WHO - calling for caution to be exercised in using artificial intelligence (AI) generated large language model tools (LLMs)
17th May 2023The World Health Organization (WHO) is calling for caution to be exercised in using artificial intelligence (AI) generated large language model tools (LLMs) to protect and promote human well-being, human safety, and autonomy, and preserve public health.
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EMA - CTIS newsflash
10th May 20235 May 2023
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EMA - Questions and Answers about the raw data proof-of-concept pilot for industry
10th May 2023Scope, terms of participation and data submission process
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EMA - Review of transparency rules for the EU Clinical Trials Information System (CTIS)
10th May 2023EMA has opened a public consultation to review the transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS) in the European Union (EU). Stakeholders are invited to send their comments via an online form by midnight (CET) on 28 June 2023.
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EMA - SME Office Newsletter 58
10th May 2023The newsletter for micro-, small- and medium-sized enterprises (SMEs),
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EMA - Statement from Emer Cooke on the end of the COVID-19 public health emergency
10th May 2023On Friday, the WHO Director General declared an end to the Public Health Emergency of International Concern (PHEIC) for the disease caused by the coronavirus SARS-CoV-2. I welcome this important milestone and would like to share some thoughts about what this means for EMA.
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FDA - Additional Steps to Advance Decentralised Clinical Trials
10th May 2023The agency released a new draft guidance that provides recommendations for sponsors, investigators and other stakeholders regarding the implementation of DCTs to advance medical product development and research.
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FDA - Q9(R1) Quality Risk Management
10th May 2023The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Q9(R1) Quality Risk Management.”
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MHRA - Good Manufacturing Practice Symposium 2023
10th May 2023A write up of the event by Graham Carroll
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MHRA - ICH E6(R3) Good Clinical Practice guidance - Step 2 Public Consultation
10th May 2023The E6(R3) overarching principles, Annex 1, Glossary and 3 Appendices will replace the current E6(R2). These are anticipated to reach Step 2 soon and will be available for public consultation.
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MHRA - Implementation of the Future Regulations
10th May 2023The government intends to introduce regulations in future that will implement a substantial reform of the current regulatory framework for medical devices in the UK.
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MHRA - Publication Scheme
10th May 2023The Medicines and Healthcare products Regulatory Agency (MHRA) is committed to making transparency and accountability to the public a fundamental principle of how we do business.
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MHRA Blog - Ensuring Child Vaccine Safety at Every Step
10th May 2023Shiva Ramroop, discusses how we ensure the safety of vaccines for children in the UK.
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Swissmedic - Changes to the guidance document GMP compliance by foreign manufacturers and the form Declaration by the Responsible Person for foreign manufacturers
10th May 2023Clarification of the requirements for the submission of audit reports
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MHRA - Good Distribution Practice Symposium 2023
2nd May 2023Held on 21-22 February 2023 - here is write up of the event.
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EMA - CHMP Highlights 24 - 26 April 2023
27th April 2023Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 - 26 April 2023
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EMA - CVMP Meeting Highlights 18-20 April 2023
26th April 2023Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 18-20 April 2023
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EMA - CTIS newsflash – 21 April 2023
26th April 2023This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
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EMA - Clinical Trials Highlights 14
26th April 2023April 2023 issue of Clinical Trials Highlights.
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EMA - Human Medicines Highlights Newsletter 168
26th April 2023Key information for patients, consumers and healthcare professionals.
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EMA - PRAC 11-14 April 2023
26th April 2023Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 April 2023
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EMA - Reducing risks to human and animal health from exposure to N-methyl pyrrolidone in veterinary medicines
26th April 2023On 8 December 2022, EMA’s veterinary medicines committee, the CVMP, recommended new measures to reduce the risks from exposure to the excipient N-methyl pyrrolidone (NMP) for women who may handle NMP-containing veterinary medicines and animals that are given these medicines.
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EMA - Single-arm trials as pivotal evidence for the authorisation of medicines in the EU
26th April 2023EMA has opened a public consultation on a PDF icon reflection paper that discusses key concepts for single-arm clinical trials that are submitted as pivotal evidence in support of marketing authorisation applications for medicines in the European Union (EU).
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FDA - A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers
26th April 2023This guidance provides information on risk-based approaches to monitoring the conduct of clinical investigations of human drug and biological products, medical devices, and combination products.
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FDA - Final Guidance on Animal Drug User Fees and Fee Waivers and Reductions
26th April 2023This version of the guidance replaces the version made available in July 2017. This revision of the guidance document updates hyperlinks, mailing, and contact information.
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FDA - The Office of New Drugs' Efforts to Expand Regulatory Science Research
26th April 2023CDER’s Office of New Drugs (OND) developed a research program in 2018 to centralise and enhance its regulatory science research activities. Recently, the OND Research Program (OND-RP) published its first two fiscal year annual reports
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MHRA - Access Consortium: joint pipeline meetings
26th April 2023The Access Consortium is offering joint pipeline meetings to pharmaceutical and biotechnology companies.
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MHRA - Chair Stephen Lightfoot Standing Down
26th April 2023After almost 8 years as a Board Member, Stephen has decided to step down on 11 July 2023.
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MHRA - MORE platform API (Application Programming Interface) set up - user reference guide
26th April 2023Instructions for integrating with the new production MORE platform API.
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WHO - Key leadership appointments made to drive WHO strategic direction and initiatives
26th April 2023The World Health Organization (WHO) has appointed five new senior figures to its headquarters leadership team in Geneva.
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APIC - Data Integrity FAQs
19th April 2023A collection of frequently asked questions that have been submitted by the industry to the DI taskforce.
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EMA - Interview with Peter Arlett
19th April 2023LinkedIn Live interview with Peter Arlett: Real-world evidence in medicines regulation, 20 April at 14:00-14:30 CET
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EMA - Human Medicines Highlights Issue April 2023
12th April 2023Issue 168
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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27 - 30 March 2023
12th April 2023View the meeting highlights.
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EMA - New features further strengthen PRIority Medicines scheme (PRIME)
12th April 2023EMA is introducing a number of new features to the PRIority Medicines (PRIME) scheme to strengthen its support for the development of medicines in areas of unmet medical needs.
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MHRA Blog - Happy 75th Anniversary to the World Health Organization
12th April 2023On 6th April 1948, the United Nations (UN) came together to establish a global organisation that promotes health, keeps the world safe, and serves the vulnerable. Seven decades later, the World Health Organization (WHO) is celebrating its 75th anniversary.
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ECA - New Guide on GMP Compliant Equipment Design
5th April 2023The purpose of this Guide is to illustrate the generally applicable requirements for the design of equipment and to explain how the connection between design and the statement “produced in compliance with GMP” can be made.
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ICH - Q9 QRM Revision reaches step 4
5th April 2023Since 2005, the ICH Q9 Guideline on Quality Risk Management has represented the state of the art. A revision was announced at the end of 2020. In January, this revision has reached stage 4 and is now moving into implementation.
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EMA - DARWIN EU® has completed its first studies and is calling for new data partners
29th March 2023DARWIN EU®, the Data Analysis and Real-World Interrogation Network, has accomplished its first year of establishment. Following the set-up of the DARWIN EU® Coordination Centre in February 2022, the first ten data partners were onboarded. The network also initiated its first four studies using real-world data (RWD) from across Europe to better understand diseases, populations and the uses and effects of medicines.
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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 March 2023
29th March 2023Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 March 2023
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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13 - 16 March 2023
29th March 2023Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13 - 16 March 2023
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MHRA - MHRA good clinical practice (GCP) metrics reports
29th March 2023MHRA good clinical practice (GCP) metrics reports of compliance issues, 2019-2020
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UKRI - equality, diversity and inclusion strategy
29th March 2023UKRI has published the first edition of its EDI strategy, which outlines our ambition for a thriving research and innovation system, by everyone, for everyone.
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EMA - Mid-point Report Published
27th March 2023EMA has published a report summarising the mid-term achievements of its Regulatory Science Strategy (RSS) to 2025. The report provides an overview of the main deliverables achieved between March 2020 and December 2022 across the human and veterinary areas.
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EDQM - CEP 2.0
23rd March 2023The European Directorate for the Quality of Medicines & HealthCare (EDQM) is seeking input from Certification of suitability (CEP) users for the implementation of the CEP 2.0.
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EMA - Guideline on computerised systems and electronic data in clinical trials
22nd March 2023This guideline replaces the 'Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials' (EMA/INS/GCP/454280/2010).
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MHRA - Consultation on proposals for legislative changes for clinical trials
22nd March 2023The MHRA and the Department of Health in Northern Ireland, working closely with the HRA, consulted on a set of proposals to update, improve and strengthen the UK legislation that underpins the regulation of clinical trials. Having analysed over 2000 responses received, we will now take forward legislation to reform of the UK clinical trials regulatory framework that will: Ensure patients and their safety are at the focus of all clinical trials and bring the benefits of clinical trials to everyone Create a proportionate and flexible regulatory environment Cement the UK as a destination for international trials Provide a framework that is streamlined, agile and responsive to innovation This package of changes will deliver on our vision for a more proportionate, streamlined, flexible and effective clinical research environment, putting patients at the heart and the UK at the forefront of innovative regulation for clinical trials.
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MHRA - to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years
22nd March 2023The legislative changes will help to make the UK one of the best countries in the world to conduct clinical research for patients and researchers.
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NHS HRA - Increasing the diversity of people taking part in research
22nd March 2023The HRA and the MHRA are committed to enabling the highest quality health and social care research which can benefit the whole UK population. We are working together to help researchers increase the diversity of people taking part in research in the UK and we will set out our expectations in future guidance.
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ECA - A Road Map to GMP Compliant Design - The New ECA Guide
15th March 2023The 115 page ECA Guide was launched and first published at the ECA Live Online Conference GMP-compliant Equipment Design in November 2022 - and can now be downloaded free of charge.
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EMA - CTIS Newsflash, March 2023
15th March 2023With the aim to enhance communication with the CTIS user community, this regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
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EMA - Human Medicines Highlights Newsletter, March 23
15th March 2023Key information for patients, consumers and healthcare professionals - Published monthly by the European Medicines Agency
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FDA - Q13 Continuous Manufacturing of Drug Substances and Drug Products
15th March 2023FDA issued final guidance.
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MHRA - Advisory Group Reform Proposals
15th March 2023Update to the Life Sciences Council Joint Statement on Medical Devices Regulatory Reform.
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MHRA - Fees Update
15th March 2023MHRA fees for 2022 - 2023 are remaining the same as 2021 - 2022.
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MHRA - Laboratories that are members of the UK GLP Compliance Monitoring Programme
15th March 2023List updated 14 March 2023
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MHRA - List of Accredited Phase I Units
15th March 2023List updated 15th March 2023
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MHRA - Patient Involvement Strategy: One Year On
15th March 2023The Medicines and Healthcare products Regulatory Agency (MHRA) published its Patient Involvement Strategy in October 2021. This defined how we will engage and involve the public and patients in our work.
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MHRA Blog - Reflections on the shared commitment to public involvement
15th March 2023Blog post by Caroline Barker-Hurden, Posted on 13th March 2023
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MHRA Blog Post - Large Language Models and software as a medical device
6th March 2023Large Language Models (LLMs), including ChatGPT and Bard, offer great potential to mimic human conversation. LLMs only directed toward general purposes and whose developers make no claim that the software can be used for a medical purpose are unlikely to qualify as medical devices.
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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)
1st March 202320 - 23 February 2023
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EMA - CTIS newsflash – 24 February 2023
1st March 2023With the aim to enhance communication with the CTIS user community, this regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
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EMA - Clinical Trials Highlights
1st March 2023February 2023
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EMA - Veterinary medicines: highlights of 2022
1st March 2023EMA has published an PDF icon overview of its key recommendations of 2022 regarding the authorisation and safety monitoring of veterinary medicines.
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MHRA - Drug Safety Update: monthly PDF newsletter
1st March 2023Monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor, the Commission on Human Medicines
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MHRA - Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU
1st March 2023The European Parliament has voted to adopt an extension of the transition period for the EU Medical Device Regulations and to extend the validity of certain device certificates
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MHRA - MHRA Board Meeting held in public
1st March 2023Date: Tuesday 21 March 2023/Location: Webinar
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Meeting highlights from the CVMP 14-16 February 2023
1st March 202314-16 February 2023 Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 February 2023
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HRA - #makeitpublic Week
27th February 2023HRA's Make it Public strategy signals an ambition to transform research transparency in the UK.
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HRA Blog - Patients need access to industry clinical trials
27th February 2023In October 2022, the Association for the British Pharmaceutical Industry reported that the number of clinical trials run by pharmaceutical companies in the UK had declined over recent years. In October 2022, the Association for the British Pharmaceutical Industry reported that the number of clinical trials run by pharmaceutical companies in the UK had declined over recent years. This wasn’t a case of industry just complaining about how hard it is to run their business. More importantly, they explained the impact this is having on the NHS and all of us as patients. And it’s not good news.
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EMA - Human Medicines Highlights 2022
21st February 2023EMA releases highlights from 2022.
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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC)
15th February 20236 - 9 February 2023
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EMA - A new role for EMA in monitoring and mitigating critical medical device shortages during public health emergencies
15th February 2023As of 2 February 2023, EMA’s additional responsibilities regarding the monitoring and mitigation of shortages of critical medical devices during public health emergencies will apply. The new provisions are the last remaining part to be implemented of Regulation (EU) 2022/123, that reinforces EMA’s role in crisis management of critical medicinal products and medical devices during public health emergencies.
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EMA - Actions to support the development of medicines for children
15th February 2023Regulators in the European Union (EU) have taken several initiatives in the past four years to increase the efficiency of paediatric regulatory processes and boost the development of medicines for children.
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EMA - CTIS newsflash – 10 February 2023
15th February 2023Now Released
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EMA - Human Medicines Highlights Issue 166
15th February 2023Now Released
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EMA - Public consultation on a multi-stakeholder platform to improve clinical trials in the EU
15th February 2023On 3 February 2023, EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC) are launching a public consultation on the establishment of a multi-stakeholder platform to improve clinical trials in the European Union (EU). EMA - Public consultation on a multi-stakeholder platform to improve clinical trials in the EU
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MHRA - List of Accredited Phase I Units (Last Updated 01 February 2023)
15th February 2023List of Accredited Phase I Units updated 1 February 2023.
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MHRA - Manufacture of Investigational Medicinal Products – Frequently Asked Questions
15th February 2023A review and update of the 2016 blog.
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MHRA - UK to introduce first-of-its-kind framework to make it easier to manufacture innovative medicines at the point of care
15th February 2023The establishment of a regulatory framework for POC manufacturing would bring a range of benefits to patients, healthcare professionals and innovators.
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SNOMED International and the EDQM collaborate on map development
15th February 2023SNOMED International and the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, have signed an agreement governing the creation, maintenance and distribution of a map between both organisations’ terminologies. The agreement came into effect in September 2022.
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WHO - ICD-11 2023
15th February 2023ICD-11 came into in effect in January 2022 for the national and international recording and reporting of causes of illness, death - and more.
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WHO - WHO launches new roadmap on breast cancer
15th February 2023The World Health Organization (WHO) released a new Global Breast Cancer Initiative Framework today providing a roadmap to attain the targets to save 2.5 million lives from breast cancer by 2040.
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WHO -Understanding our social interactions to improve influenza pandemic preparedness and response
15th February 2023The WHO Regional Office for the Western Pacific has taken steps to explore the role and potential of dark social communication for promoting health messages and reducing the spread of misleading information during and between influenza pandemics.
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Swissmedic - Validity of GMP certificates during the COVID-19 pandemic
8th February 2023Update of the validity period of EMA GMP certificates
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EMA - CTIS newsflash released 27th Jan 2023
2nd February 2023EMA - CTIS newsflash released
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EMA - Joint statement by Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) on shortages of antibiotic medicines
2nd February 2023EMA, the European Commission and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), are closely monitoring and responding to current shortages of antibiotics affecting the EU. Shortages of medicines have been an ongoing public health concern and the situation in the EU has been exacerbated by geopolitical events or trends such as the war in Ukraine, the energy crisis and high inflation rates.
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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2023
2nd February 2023EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2023
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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 17-18 January 2023
2nd February 2023EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 17-18 January 2023
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EMA - Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU
2nd February 2023Use of CTIS becomes mandatory for new clinical trial applications in the EU
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EMA - update on shortages of antibiotics in the EU
2nd February 2023EMA - update on shortages of antibiotics in the EU EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) met on Thursday to discuss the progress made and to agree on the next steps in the coordinated response to the ongoing shortages of antibiotic medicines containing amoxicillin (alone and in combination with clavulanic acid) in the EU. The MSSG is made up of representatives from EMA, the European Commission and the Heads of Medicines Agencies (HMA).
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FDA - Dosage and Administration Section of Labelling for Human Prescription Drug and Biological Products — Content and Format
2nd February 2023Dosage and Administration Section of Labelling for Human Prescription Drug and Biological Products — Content and Format Open for Comment
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FDA - Format and Content of a REMS Document Guidance for Industry for Comment
2nd February 2023Open for Comment
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ICH - ICH E2B(R3) Q&As Version 2.4 for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) has reached Step 4 of the ICH Process.
2nd February 2023The ICH Secretariat is pleased to announce that as of 17 January 2023, the updated ICH E2B(R3) Q&As Version 2.4 for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) has reached Step 4 of the ICH Process.
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ICH - Quality Risk Management Q9(R1) Adopted
2nd February 2023Final version adopted on 18th January 2023.
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ICH - The ICH M13A draft Guideline presentation available now on the ICH website
2nd February 2023The ICH M13A draft Guideline presentation available now on the ICH website
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ICH - Training on Module I - Introduction to E2B(R3): Electronic Transmission of Individual Case Safety Reports
2nd February 2023The ICH Secretariat is pleased to announce the publication of Module I - Introduction to E2B(R3): Electronic Transmission of Individual Case Safety Reports Training Video.
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ICH - Training on Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Product
2nd February 2023The ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 4 of the ICH Process on 16 November 2022. Following the adoption of this Guideline, a Step 4 Introductory Training Presentation has been developed by the Q13 Expert Working Group.
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MHRA - Changes to completed paediatric studies guidance text
2nd February 2023MHRA have made changes made to the Completed paediatric studies guidance text and suggested a new cover letter on their website.
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MHRA - Fees Consultation Outcome
2nd February 2023MHRA - Fees Consultation Outcome
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MHRA - Innovation Office Guidance
2nd February 2023MHRA Innovation Office: guidance and support - can provide access to world-class regulatory knowledge, expertise and experience from within the MHRA.
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MRC - Motion capture tech could predict disease progression
2nd February 2023MRC - Motion capture tech could predict disease progression
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PIC/S - Adoption and Entry into force of New GDP Guidance Documents
2nd February 2023Adoption and Entry into force of New GDP Guidance Documents
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WHO - OpenWHO courses
2nd February 2023Three years of pandemic learning response: reaching learners across the world with life-saving health knowledge
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ICH - ICH M10 on bioanalytical method validation - Scientific guideline
30th January 2023ICH M10 on bioanalytical method validation - Scientific guideline
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PharmaTechnica - Free Annex 1 Presentation
30th January 2023A presentations on Annex 1 presented by GMP Inspector Dr Rainer Gnibl is now available (sign up required).
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ANSM - The implementation of the Clinical Trial Regulation State of play at EU and national level Future initiatives
25th January 2023ANSM have released their webinar presentation regarding The implementation of the Clinical Trial Regulation State of play at EU and national level - Future initiatives
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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 - 12 January 2023
19th January 2023EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 - 12 January 2023
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EMA - CTIS newsflash – 13 January 2023
19th January 2023CTIS newsflash – 13 January 2023
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EMA - Clinical Trials Information System (CTIS) - Sponsor Handbook
19th January 2023EMA - Clinical Trials Information System (CTIS) - Sponsor Handbook
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EMA - Human Medicines Newsletter, Jan 23
19th January 2023EMA - Human Medicines Newsletter, January 23
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EMA - SME Newsletter Jan 2023
19th January 2023EMA - SME Newsletter Jan 2023
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FDA - Draft Guidance for Industry on Statistical Approaches for Assessing Bioequivalence
19th January 2023FDA Draft Guidance for Industry on Statistical Approaches for Assessing Bioequivalence
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FDA - FDA Agreement on Mutual Recognition between the Swiss Confederation and the United States of America Relating to Pharmaceutical GMP
19th January 2023FDA have signed an Agreement on Mutual Recognition between the Swiss Confederation and the United States of America Relating to Pharmaceutical Good Manufacturing Practice.
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MHRA - Horizon Scanning Case Study
19th January 2023MHRA - Horizon Scanning Case Study
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MHRA - MHRA increases UK assessment capacity for in-vitro diagnostic devices
19th January 2023MHRA increases UK assessment capacity for in-vitro diagnostic devices
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MHRA - Professor Tom Clutton-Brock MBE new Chair of the Interim Devices Working Group
19th January 2023MHRA - Professor Tom Clutton-Brock MBE new Chair of the Interim Devices Working Group
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EMA: Facilitating Decentralised Clinical Trials in the EU
11th January 2023The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published recommendations that aim to facilitate the conduct of decentralised clinical trials (DCTs) while safeguarding the rights and well-being of participants as well as the robustness and reliability of the data collected. This is an outcome of their joint initiative to Accelerate Clinical Trials in the European Union (ACT EU).
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EMA: Virtual Public CTIS Event
11th January 2023The EMA are holding a virtual public CTIS event “CTIS Event on Readiness for mandatory use of the Clinical Trials Regulation from 31 January 2023”.
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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2022
21st December 2022EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2022
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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 December 2022
21st December 2022EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 December 2022
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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November - 1 December 2022
21st December 2022EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November - 1 December 2022
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EMA - Recommendation Paper on Decentralised Elements in Clinical Trials
21st December 2022The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published recommendations that aim to facilitate the conduct of decentralised clinical trials (DCTs) while safeguarding the rights and well-being of participants as well as the robustness and reliability of the data collected. This is an outcome of their joint initiative to Accelerate Clinical Trials in the European Union (ACT EU).
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MHRA - Business Impact Target
21st December 2022MHRA assesses its regulatory impact on businesses. Non-qualifying Regulatory Provisions (NQRP) summary 2021-22 available.
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MHRA Board Meetings in 2023
21st December 2022MHRA Board Meetings in 2023
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MHRA to receive nearly £1m BEIS funding to unlock digital, data and scientific regulatory innovation
21st December 2022MHRA to receive nearly £1m BEIS funding to unlock digital, data and scientific regulatory innovation
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TransCelerate - Considerations for Data Relevance and Reliability
21st December 2022Does your organisation provide or utilise Real-World Evidence / Real-World Data for regulatory-grade research? TransCelerate Biopharma Inc.’s Real-World Data (RWD) Audit Readiness Initiative wants to hear from you!
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EMA - public consultation - Reflection paper on the application of Article 40(5) of Regulation (EU) 2019/6 for certain categories of variations.
15th December 2022This draft reflection paper provides potential criteria to support the demonstration of a reduction in the antimicrobial or antiparasitic resistance, or an improvement of the benefit-risk balance. Comments should be provided using this template and sent to vet-guidelines@ema.europa.eu by 28 February 2023.
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MHRA Blog - When is a clinical trial halt not a clinical trial halt?
15th December 2022As the regulator, the safety of those volunteering to participate in clinical trials is our first priority, and our oversight of trial conduct is informed by trial sponsors efficiently notifying us of safety issues during the conduct of their trial. This blog aims to clarify regulatory expectations for notification of temporary halts via a substantial amendment and requests to restart a trial after a temporary halt has been notified.
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