- Home
-
Learn, develop, connect
Foundations first: reconstructing quality
Book this year's International QA Conference now.
More information
20% off today!
Good Clinical Practice Inspection Preparation - Navigating a Rapidly Changing Environment, 9th-10th October 2024
More information -
Membership
RQA Community Hub
Join the community - networking, discussion and more. Open to all.
More information -
Knowledge Hub
Contribute to Quasar Magazine
Could you write an interesting article for the RQA community?
More information -
About us
Recent News
If you are aware of any news items that would be of interest to the RQA membership, please contact the RQA office.
-
MHRA - Wholesalers and manufacturers guidance following agreement of the Windsor Framework
13th September 2024Actions QPs, RPis and RPs need to take following agreement of the Windsor Framework
Read More+ -
EMA - Human Medicines Newsletter
5th September 2024August 2024
Read More+ -
FDA - Bioresearch Monitoring Technical Conformance Guide
5th September 2024Final guidance available
Read More+ -
FDA - New Final Guidances Issued by Center for Veterinary Medicine
5th September 2024CVM GFI #63 (VICH GL1) and CVM GFI #64 (VICH GL2)
Read More+ -
FDA - Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products
5th September 2024Final Guidance Released
Read More+ -
FDA - Roundup, 30th August 2024
5th September 2024An at-a-glance summary of news from around the agency
Read More+ -
FDA - Warning Letter to Italian Company
5th September 2024The warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. 3. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).
Read More+ -
MHRA - Advertising Investigations
5th September 2024Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.
Read More+ -
MHRA - Appointments of four MHRA Non-Executive Directors extended until 31 August 2025
5th September 2024Extended from 1 September 2024 until 31 August 2025.
Read More+ -
MHRA - Consultation on Statutory Fees
5th September 2024Proposals on ongoing cost recovery
Read More+ -
MHRA - Pharmacovigilance following agreement of the Windsor Framework
5th September 2024MHRA have published information on the implementation of changes to pharmacovigilance for medicines authorised in the UK following the agreement of the Windsor Framework.
Read More+ -
WHO - Guidance aims to curb antibiotic pollution from manufacturing
5th September 2024New global guidance released
Read More+ -
MHRA - Performance Metrics Published
16th August 2024MHRA performance metrics for clinical trials and established medicines assessment.
Read More+ -
EMA - Veterinary Scientific Guidance Update - Adopted and Draft Guidance
14th August 2024New adopted and draft guidelines relating to Veterinary Products
Read More+ -
MHRA - Medicines Pipeline data
14th August 2024New Guidance Published
Read More+ -
MHRA - Pre-submission Advice & Support
14th August 2024New Guidance Published
Read More+ -
VICH - Veterinary Scientific Guidance Updates
14th August 2024Updates from 2024
Read More+ -
EMA - CTIS Simplification Force
13th August 2024As part of the work of the CTIS Simplification Force, EMA are proposing some changes to the CTIS roles matrix.
Read More+ -
EMA - Guideline on good pharmacovigilance practices (GVP) Annex I - Definitions (Rev 5)
6th August 2024Released 26th July 2024
Read More+ -
EMA - Real-world evidence framework to support EU regulatory decision-making
1st August 20242nd report on the experience gained with regulator-led studies from February 2023 to February 2024.
Read More+ -
MHRA - Drug Safety Update
1st August 2024Volume 18, 1st August 2024
Read More+ -
HRA - Demographic Survey Report
31st July 2024The HRA community were asked to complete a diversity and inclusion survey. The results help build a picture of who HRA's members are, help them understand who isn’t part of their community, and help them to take action so that members better reflect the diversity of society.
Read More+ -
HMA/EMA - Multi-Stakeholder Workshop on AI
24th July 20245th November 2024
Read More+ -
EMA public launch event on the guideline on good pharmacovigilance practices Module XVI on risk minimisation measures and its Addendum II
22nd July 2024The European Medicines Agency (EMA) is hosting an online event to launch the revised guideline on good pharmacovigilance practices (GVP) Module XVI and its Addendum II. The event will provide an overview of how stakeholder comments from the public consultation on these documents have been addressed. This will be followed by a questions and answers session for answering audience questions.
Read More+ -
EMA - Article on RWE
19th July 2024Co-authored by EMA and published in the Clinical Pharmacology & Therapeutics journal.
Read More+ -
eClinical Forum - New version of eCF Requirements and Webinar
19th July 2024The eClinical Forum is releasing this version (V2023.3PR) as a service to the eClinical Community.
Read More+ -
EMA - ICH reflection paper on pursuing opportunities for harmonisation in using real-world data to generate real-world evidence, with a focus on effectiveness of medicines
9th July 2024This reflection paper was co-developed by the European Medicines Agency, the United States of America's (USA) Food and Drug Administration (FDA), and Health Canada and adopted in June 2024 by the Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Assembly.
Read More+ -
EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024
9th July 202410 new medicines recommended for approval; another 11 medicines recommended for extension of their therapeutic indications
Read More+ -
FDA - Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products
9th July 2024Draft Guidance Released
Read More+ -
FDA - M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines
9th July 2024Draft Guidance Released
Read More+ -
FDA - Updates to Guidance to Further Empower Companies to Address the Spread of Misinformation
9th July 2024The U.S. Food and Drug Administration is advancing its mission of ensuring the public has access to accurate, up-to-date science-based information to inform decisions about FDA-regulated medical products to maintain and improve their health.
Read More+ -
HMA-EMA - 5th HMA/EMA Big Data Stakeholder Forum
9th July 2024Announced for Thursday, 28 November 2024.
Read More+ -
MHRA - Procurement at MHRA
9th July 2024MHRA have released information about procurement at the Agency and how they are improving procurement opportunities for small and medium-sized enterprises.
Read More+ -
WHO - MeDevIS platform announced
9th July 2024The first global open access clearing house for information on medical devices.
Read More+ -
WHO - Updates to laboratory biosecurity guidance
9th July 2024WHO recently issued updated guidance for national authorities and biomedical laboratories to manage biological risks.
Read More+ -
Efpia - Annual Regulatory GMP/GDP Inspection Survey 2023 Data
21st June 2024A report by European Federation of Pharmaceutical Industries and Associations
Read More+ -
FDA-NIH - Glossary for Clinical Research
21st June 2024Open for comment now.
Read More+ -
ICH - M14 Guideline Available for Comment
21st June 2024ICH M14 Guideline on General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines.
Read More+ -
EMA - Faster access to clinical trial information in Europe
18th June 2024The launch of a new version of the Clinical Trials Information System (CTIS) will allow earlier and more efficient access to information about clinical trials in the European Union (EU) for patients, healthcare professionals and other stakeholders. This is due to the revised transparency rules that become applicable today in Europe.
Read More+ -
EMA - Accelerating clinical trials in the EU (ACT EU): transforming the EU clinical trials landscape
17th June 2024Article co-authored by EMA.
Read More+ -
EMA - Generating clinical evidence for treatment and prevention options for long COVID
17th June 2024Article co-authored by EMA
Read More+ -
MHRA - Guidance Released Machine learning medical devices: transparency principles
14th June 202413th June 2024
Read More+ -
MHRA - Updated Guidance Software and artificial intelligence (AI) as a medical device
14th June 2024This guidance provides access to important Software Group outputs that might be of assistance.
Read More+ -
EMA - ACT EU launching two advice pilots
13th June 2024The Accelerating Clinical Trials in the EU (ACT EU) initiative is today (10th June 2024) launching two advice pilots aimed at improving the quality of applications for clinical trials, the foundation for the development of safe and effective medicines in Europe.
Read More+ -
FDA - Research on AI/ML-Based Medical Devices
13th June 2024CDRH’s Office of Science and Engineering Laboratories (OSEL) Information.
Read More+ -
ICH - Assembly Meeting
13th June 2024ICH Assembly Meeting Write Up, Fukuoka, Japan, June 2024 The Assembly of the International Council for Harmonisation (ICH) met in-person on 4 & 5 June 2024, in Fukuoka, Japan in parallel of meetings of 13 Working Groups, and preceded by meetings of the ICH Management Committee and the MedDRA Management Committee. The ICH continues to expand and welcomed ANMAT, Argentina and JFDA, Jordan as new ICH Members, bringing ICH to a total of 23 Members and 35 Observers.
Read More+ -
ICH E6(R3) EWG Work Plan
11th June 2024Published Work Plan
Read More+ -
EMA - Annual Report 2023
6th June 2024Published on 30th May 2024 EMA’s annual report 2023 published today details the Agency’s contributions to public and animal health in the European Union (EU). With a fresh layout and new interactive features, the report offers insights into EMA's strategic initiatives and priority areas that guided its work in 2023.
Read More+ -
EMA - Human Medicines Highlights Newsletter
6th June 2024May 2024 The newsletter for patients, consumers and healthcare professionals
Read More+ -
EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)
6th June 202427-30 May 2024
Read More+ -
EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP)
6th June 202421st - 22nd May 2024
Read More+ -
FDA - Platform Technology Designation Program for Drug Development
6th June 2024Guidance Document available for comment
Read More+ -
FDA - Processes and Practices Applicable to Bioresearch Monitoring Inspections
6th June 2024The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Processes and Practices Applicable to Bioresearch Monitoring Inspections.”
Read More+ -
FDA - Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of BIMO Inspections
6th June 2024Guidance document open for comment.
Read More+ -
FDA Roundup: 4th June 2024
6th June 2024An at-a-glance summary of news from around the agency.
Read More+ -
ICH - M12 Guideline reaches Step 4 of the ICH Process
6th June 2024The ICH M12 Guideline “Drug Interaction Studies” and “Drug Interaction Studies Questions and Answers” reached Step 4 of the ICH Process on 21 May 2024.
Read More+ -
EMA - Horizon scanning on veterinary novel therapies
30th May 2024The European Medicines Agency has launched a horizon scanning survey on veterinary novel therapies.
Read More+ -
EMA - One Health: How EU agencies are tackling environmental and public health together
23rd May 2024On 22nd May 2024, the European Centre for Disease Prevention and Control (ECDC), the European Chemicals Agency (ECHA), the European Environment Agency (EEA), the European Food Safety Authority (EFSA), and the European Medicines Agency (EMA) published a joint framework for action to strengthen cooperation to support the implementation of the One Health agenda in the European Union (EU).
Read More+ -
HMA - Recommendation Paper on Principles of GLP
23rd May 2024New recommendation paper on principles of Good Laboratory Practices (GLP) for clinical trial applications under the EU Clinical Trials Regulation (Regulation (EU) No 536/2014)
Read More+ -
MHRA - MHRA announces consultation on improved safety for high risk in vitro diagnostic devices
23rd May 2024Launch of a a four-week consultation which will support improved safety for certain high risk in vitro diagnostic (IVD) devices. IVD devices are used to examine samples taken from the human body and to diagnose and monitor health conditions. For example, devices can determine blood glucose levels and can identify infectious diseases. Accurate performance and trust in the quality of these products are crucial to healthcare professionals considering their use in treating patients. The new policy we are consulting on would require manufacturers to comply with additional measures for certain high risk IVDs, such as blood tests used to identify blood type before transfusions or tests which identify life-threatening diseases, introducing harmonised requirements for these products. We are also seeking views on the removal of the Coronavirus Test Device Approval (CTDA) process to avoid duplication of regulatory requirements for COVID-19 tests against the Common Specification requirements. The MHRA intends to incorporate updates to IVD common specifications within a draft Statutory Instrument as part of the future core medical device regulations to be published later in 2024. The updated regulations will then come into force in 2025. Dr Laura Squire, MedTech Regulatory Reform Lead and Chief Healthcare Quality and Access Officer, MHRA said: We look forward to feedback on our consultation on common specification of IVDs, as we look to strengthen safety requirements around certain classes of crucial diagnostic devices.
Read More+ -
MHRA - proposed framework for international recognition of medical devices
23rd May 2024MHRA announces a proposed framework for international recognition of medical devices
Read More+ -
MHRA - launches AI Airlock to address challenges for regulating medical devices that use Artificial Intelligence
9th May 2024New regulatory sandbox for AI as a Medical Device (AIaMD).
Read More+ -
EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)
8th May 202422-25 April 2024
Read More+ -
EMA - One Health: a joint framework for action published by five EU agencies
8th May 2024The European Centre for Disease Prevention and Control (ECDC), the European Chemicals Agency (ECHA), the European Environment Agency (EEA), the European Food Safety Authority (EFSA), and the European Medicines Agency (EMA) published a joint framework for action to strengthen cooperation to support the implementation of the One Health agenda in the European Union (EU).
Read More+ -
FDA - Roundup
8th May 20247th May 2024
Read More+ -
MHRA - April MedTech regulatory reform update: international recognition, IVDs and AI
8th May 2024Laura Squire, 25 April 2024
Read More+ -
MHRA - Update on pioneering initiative on regulation and evaluation of digital mental health technologies
8th May 2024An MHRA and NICE partnership, funded by Wellcome, is addressing key challenges for regulating and evaluating digital mental health technologies (DMHTs) with input from patients, the public and mental health professionals.
Read More+ -
EMA - draft reflection paper on the use of real-world data in non-interventional studies to generate real-world evidence
7th May 2024We are pleased to inform you about the publication of a draft reflection paper on the use of real-world data in non-interventional studies to generate real-world evidence, which is now open for public consultation. The reflection paper discusses methodological and data quality aspects of non-interventional studies using real-world data to generate real-world evidence for regulatory purposes.
Read More+ -
FDA - Data Integrity for In Vivo Bioavailability and Bioequivalence Studies
7th May 2024Submit Comments by 03/07/2024
Read More+ -
MHRA - sets out its strategic approach to artificial intelligence (AI)
1st May 2024The Medicines and Healthcare products Regulatory Agency (MHRA) has today (30 April 2024) set out its strategic approach to artificial intelligence (AI).
Read More+ -
EDQM - Public consultation on Traceability of Medicines in Hospital Settings
24th April 2024Share your comments with the EDQM
Read More+ -
EMA - COVID-19 vaccine strain updates
24th April 2024Global regulators agree on timing and data requirements
Read More+ -
EMA - Human Medicines Newsletter 379
24th April 2024April 2024
Read More+ -
EMA - Meeting highlights from the CVMP
24th April 202416-18 April 2024
Read More+ -
EMA - New recommendations to strengthen supply chains of critical medicines
24th April 2024EMA has published a number of recommendations to address vulnerabilities in the production and delivery of medicines included in the Union list of critical medicines and strengthen their supply chain.
Read More+ -
FDA - Data Standards Catalog - Open for Comments
24th April 2024Released April 2024
Read More+ -
FDA Roundup - 23rd April 2024
24th April 2024An at-a-glance summary of news from around the agency.
Read More+ -
MHRA - Notify MHRA about a clinical investigation for a medical device - Guidance Updated
24th April 2024Information for manufacturers added.
Read More+ -
MHRA - RegulatoryConnect
24th April 2024The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
Read More+ -
WHO - launch of first ever Patient Safety Rights Charter
24th April 2024It is the first Charter to outline patients’ rights in the context of safety, and will support stakeholders in formulating the legislation, policies and guidelines needed to ensure patient safety.
Read More+ -
EMA - Revised CTIS transparency rules will become applicable on 18 June 2024
22nd April 2024Launch of a new version of the CTIS public portal.
Read More+ -
EMA - Draft guideline on VICH GL60 Good manufacturing practice for active ingredients used in veterinary medicinal products
18th April 2024Consultation ended 25MAR2024
Read More+ -
EMA - Draft guideline on data requirements for veterinary medicinal products for zootechnical purposes - Revision 1
18th April 2024Consultation end: 31MAY2024
Read More+ -
EMA - Guideline on Quality Aspects of Pharmaceutical Veterinary Medicines for administration via drinking water
18th April 2024Annex on compatibility studies between veterinary medicinal products and biocidal products.
Read More+ -
EMA - Live recombinant vector vaccines for veterinary use - Scientific guideline
18th April 2024Consultation end: 31MAY2024
Read More+ -
VICH - GMP for API: Good Manufacturing Practive for Active Pharmaceutical Ingredient used in Veterinary Medicinal Products
18th April 2024Consultation end: March 2024
Read More+ -
VICH - Pharmaceutical development: pharmaceutical development for veterinary medicinal products
18th April 2024Consultation end: 15AUG2024
Read More+ -
VICH - Reproduction: Studies to evaluate the safety of residues of veterinary drug in human food: reproduction studies
18th April 2024Consultation end: 31JUL2024
Read More+ -
EMA - PRAC Meeting Highlights 8-11 April 2024
16th April 2024Pharmacovigilance Risk Assessment Committee
Read More+ -
FDA - Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards
16th April 2024Open for comments
Read More+ -
MHRA - DSUR Submissions and Fees are Changing
16th April 2024From 1st June 2024
Read More+ -
NHS - AI and Digital Regulations Service (AIDRS)
15th April 2024Building the AI and Digital Regulations Service
Read More+ -
EMA - EMA Management Board: highlights of March 2024 meeting
28th March 2024Outcomes of the EMA Management Board meeting.
Read More+ -
EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)
28th March 202418-21 March 2024
Read More+ -
EMA - adjusted fees for applications to EMA from 1 April 2024
28th March 2024The European Medicines Agency (EMA) reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on 1 April 2024.
Read More+ -
FDA - Guidance Documents for Consultation
28th March 2024Guidance Documents open for public consultation.
Read More+ -
FDA Roundup, 26th March 2024
28th March 2024An at-a-glance summary of news from around the agency:
Read More+ -
MHRA - Drug Safety Update, March 2024
28th March 2024The monthly newsletter from the Medicines and Healthcare products Regulatory Agency and its independent advisor the Commission on Human Medicines
Read More+ -
MHRA - warning of unsafe counterfeit anti-choking devices
28th March 2024Thousands of counterfeit or unbranded copies of LifeVac anti-choking devices are being sold across the UK. The public is reminded to check their product carefully against the images in MHRA guidance to identify whether it is a counterfeit.
Read More+ -
Veterinary Scientific Guidance Update
28th March 2024EMA and VICH Adopted and Draft Guidance.
Read More+ -
WHO - Second Week of Quality Training Announced
28th March 2024WHO is pleased to announce the second edition of its Week of Quality training program, focusing on In Vitro Diagnostics (IVDs) in 2024. Week of Quality for In Vitro Diagnostics (IVDs): April 15-18, 2024 Week of Quality for Medicines: May 13-16, 2024 Week of Quality for Vaccines & Biotherapeutics: June 10-13, 2024
Read More+ -
Gov UK - Disgraced company director convicted of falsifying medicine quality data
22nd March 2024A company director and his pharmaceutical manufacturing company were sentenced in court today after pleading guilty to two charges of falsifying data that supported the shelf life of a medicine, adversely affecting its quality in order to obtain a licence to sell the medicine in the UK.
Read More+
