If you are aware of any news items that would be of interest to the RQA membership, please contact the RQA office.
5th November 2024
The 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.
Co-authored by EMA and published in the Clinical Pharmacology & Therapeutics journal.
The eClinical Forum is releasing this version (V2023.3PR) as a service to the eClinical Community.
This 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.
10 new medicines recommended for approval; another 11 medicines recommended for extension of their therapeutic indications
Draft Guidance Released
Draft Guidance Released
The 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.
Announced for Thursday, 28 November 2024.
MHRA have released information about procurement at the Agency and how they are improving procurement opportunities for small and medium-sized enterprises.
The first global open access clearing house for information on medical devices.
WHO recently issued updated guidance for national authorities and biomedical laboratories to manage biological risks.
A report by European Federation of Pharmaceutical Industries and Associations
Open for comment now.
ICH M14 Guideline on General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines.
The 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.
Article co-authored by EMA.
Article co-authored by EMA
13th June 2024
This guidance provides access to important Software Group outputs that might be of assistance.
The 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.
CDRH’s Office of Science and Engineering Laboratories (OSEL) Information.
ICH 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.
Published Work Plan
Published 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.
May 2024 The newsletter for patients, consumers and healthcare professionals
27-30 May 2024
21st - 22nd May 2024
Guidance Document available for comment
The 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.”
Guidance document open for comment.
An at-a-glance summary of news from around the agency.
The ICH M12 Guideline “Drug Interaction Studies” and “Drug Interaction Studies Questions and Answers” reached Step 4 of the ICH Process on 21 May 2024.
The European Medicines Agency has launched a horizon scanning survey on veterinary novel therapies.
On 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).
New recommendation paper on principles of Good Laboratory Practices (GLP) for clinical trial applications under the EU Clinical Trials Regulation (Regulation (EU) No 536/2014)
Launch 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.
MHRA announces a proposed framework for international recognition of medical devices
New regulatory sandbox for AI as a Medical Device (AIaMD).
22-25 April 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).
7th May 2024
Laura Squire, 25 April 2024
An 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.
We 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.
Submit Comments by 03/07/2024
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (30 April 2024) set out its strategic approach to artificial intelligence (AI).
Share your comments with the EDQM
Global regulators agree on timing and data requirements
April 2024
16-18 April 2024
EMA 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.
Released April 2024
An at-a-glance summary of news from around the agency.
Information for manufacturers added.
The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
It 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.
Launch of a new version of the CTIS public portal.
Consultation ended 25MAR2024
Consultation end: 31MAY2024
Annex on compatibility studies between veterinary medicinal products and biocidal products.
Consultation end: 31MAY2024
Consultation end: March 2024
Consultation end: 15AUG2024
Consultation end: 31JUL2024
Pharmacovigilance Risk Assessment Committee
Open for comments
From 1st June 2024
Building the AI and Digital Regulations Service
Outcomes of the EMA Management Board meeting.
18-21 March 2024
The 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.
Guidance Documents open for public consultation.
An at-a-glance summary of news from around the agency:
The monthly newsletter from the Medicines and Healthcare products Regulatory Agency and its independent advisor the Commission on Human Medicines
Thousands 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.
EMA and VICH Adopted and Draft Guidance.
WHO 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
A 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.
Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation
The Data Analysis and Real World Interrogation Network DARWIN EU seeks ten new data partners in 2024.
Edition 178, March 2024
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC)
Released March 2024
An at-a-glance summary of news from around the agency.
The MHRA welcomes the publication of Dame Margaret Whitehead’s Equity in Medical Devices: Independent Review
March Edition
EMA and the Heads of Medicines Agencies (HMA) have launched two public electronic catalogues: one for real-world data (RWD) sources and one for RWD studies.
Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2024
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-14 February 2024
Countries that have decreased their consumption of antibiotics in both animals and humans have seen a reduction in antibiotic-resistant bacteria.
View the streams from last week's FDA, MHRA, Health Canada Symposium
Available now on the ICH website The ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs)” reached Step 2b of the ICH Process in February 2024 and entered the consultation period.
Dame June Raine, MHRA's Chief Executive, will be stepping down in the Autumn following five years in the role
Process changes from 1 March 2024 build on measures already implemented by the agency
EMA consultations open for comment now.
GMP for API
Draft guidance, Released January 2024.
Draft guidance, Feb 2024.
Med Tech Regulatory Reform: The first steps towards a new framework for medical devices in the UK
28 February 2024
Phase I period for public consultation now open.
EMA will harness its unique experience in coordinating intra-regional medicines regulation to support the strengthening of the African regulatory network. EMA has received a grant of ten million euros from the European Commission to support regulatory systems at national and regional level in Africa, and in particular for the setting up of the African Medicines Agency (AMA), in collaboration with African, European and international actors.
EMA has just launched the new Antimicrobial Sales and Use (ASU) Platform to support the collection of data by Member States on the sales and use of antimicrobials in animals.
All ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025.
On 24 January 2024 EMA published an overview of its key recommendations of 2023 regarding the authorisation and safety monitoring of veterinary medicines.
CVM GFI #286 (VICH GL60) - Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products Draft released and open for comments.
An at-a-glance summary of news from around the agency
Guidance updates on to how to notify the MHRA of changes to the PV System
The revised Schedule M prescribes the Good Manufacturing Practices (GMP) and requirements of premises, plant, and equipment for pharmaceutical products; official says this will ensure Indian guidelines are at par with global standards.
Annex 1: Manufacture of sterile medicinal products
MHRA announces two new UK Approved Bodies to certify medical devices