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EDQM - Public consultation on Traceability of Medicines in Hospital Settings
24th April 2024Share your comments with the EDQM
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EMA - COVID-19 vaccine strain updates
24th April 2024Global regulators agree on timing and data requirements
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EMA - Human Medicines Newsletter 379
24th April 2024April 2024
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EMA - Meeting highlights from the CVMP
24th April 202416-18 April 2024
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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.
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FDA - Data Standards Catalog - Open for Comments
24th April 2024Released April 2024
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FDA Roundup - 23rd April 2024
24th April 2024An at-a-glance summary of news from around the agency.
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MHRA - Notify MHRA about a clinical investigation for a medical device - Guidance Updated
24th April 2024Information for manufacturers added.
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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.
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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.
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EMA - Revised CTIS transparency rules will become applicable on 18 June 2024
22nd April 2024Launch of a new version of the CTIS public portal.
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EMA - Draft guideline on VICH GL60 Good manufacturing practice for active ingredients used in veterinary medicinal products
18th April 2024Consultation ended 25MAR2024
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EMA - Draft guideline on data requirements for veterinary medicinal products for zootechnical purposes - Revision 1
18th April 2024Consultation end: 31MAY2024
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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.
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EMA - Live recombinant vector vaccines for veterinary use - Scientific guideline
18th April 2024Consultation end: 31MAY2024
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VICH - GMP for API: Good Manufacturing Practive for Active Pharmaceutical Ingredient used in Veterinary Medicinal Products
18th April 2024Consultation end: March 2024
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VICH - Pharmaceutical development: pharmaceutical development for veterinary medicinal products
18th April 2024Consultation end: 15AUG2024
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VICH - Reproduction: Studies to evaluate the safety of residues of veterinary drug in human food: reproduction studies
18th April 2024Consultation end: 31JUL2024
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EMA - PRAC Meeting Highlights 8-11 April 2024
16th April 2024Pharmacovigilance Risk Assessment Committee
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FDA - Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards
16th April 2024Open for comments
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MHRA - DSUR Submissions and Fees are Changing
16th April 2024From 1st June 2024
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NHS - AI and Digital Regulations Service (AIDRS)
15th April 2024Building the AI and Digital Regulations Service
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EMA - EMA Management Board: highlights of March 2024 meeting
28th March 2024Outcomes of the EMA Management Board meeting.
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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)
28th March 202418-21 March 2024
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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.
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FDA - Guidance Documents for Consultation
28th March 2024Guidance Documents open for public consultation.
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FDA Roundup, 26th March 2024
28th March 2024An at-a-glance summary of news from around the agency:
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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
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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.
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Veterinary Scientific Guidance Update
28th March 2024EMA and VICH Adopted and Draft Guidance.
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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
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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.
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EC - CTD to CTR Guidance
13th March 2024Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation
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EMA - DARWIN EU® continues expanding its capacity to deliver real-world data studies
13th March 2024The Data Analysis and Real World Interrogation Network DARWIN EU seeks ten new data partners in 2024.
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EMA - Human Medicines Newsletter 178
13th March 2024Edition 178, March 2024
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EMA - Meeting highlights from the PRAC 4-7 March 2024
13th March 2024Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC)
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FDA - Final Guideline: Q14 Analytical Procedure Development AND Q2(R2) Validation of Analytical Procedures
13th March 2024Released March 2024
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FDA - Roundup 12th March 2024
13th March 2024An at-a-glance summary of news from around the agency.
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MHRA - Equity in Medical Devices
13th March 2024The MHRA welcomes the publication of Dame Margaret Whitehead’s Equity in Medical Devices: Independent Review
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MHRA - Med Tech Regulatory Reform blog
13th March 2024March Edition
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EMA - Launch of new HMA-EMA catalogues of real-world data sources and studies
29th February 2024EMA 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.
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EMA - Meeting highlights from the CHMP 19-22 February 2024
29th February 2024Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2024
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EMA - Meeting highlights from the CVMP 13-14 February 2024
29th February 2024Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-14 February 2024
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EMA - Multi-agency report highlights importance of reducing antibiotic use
29th February 2024Countries that have decreased their consumption of antibiotics in both animals and humans have seen a reduction in antibiotic-resistant bacteria.
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FDA, MHRA, Health Canada Joint Symposium Videos
29th February 2024View the streams from last week's FDA, MHRA, Health Canada Symposium
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ICH - ICH E2D(R1) draft Guideline presentation
29th February 2024Available 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.
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MHRA - Chief Executive Dame June Raine to step down later this year
29th February 2024Dame June Raine, MHRA's Chief Executive, will be stepping down in the Autumn following five years in the role
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MHRA new guidance to help applicants and shorten timeframes for assessment of established medicines
29th February 2024Process changes from 1 March 2024 build on measures already implemented by the agency
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Animal and Veterinary - Consultations Open Now
26th February 2024EMA consultations open for comment now.
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VICH - GMP for API GL60 open for consultation
26th February 2024GMP for API
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FDA - Conducting Remote Regulatory Assessments Q&A
14th February 2024Draft guidance, Released January 2024.
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FDA - Use of Data Monitoring Committees in Clinical Trials
14th February 2024Draft guidance, Feb 2024.
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MHRA - The first steps towards a new framework for medical devices in the UK
14th February 2024Med Tech Regulatory Reform: The first steps towards a new framework for medical devices in the UK
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MHRA Pharmacovigilance Symposium 2024
14th February 202428 February 2024
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Public Consultation - Declaration of Helsinki
8th February 2024Phase I period for public consultation now open.
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EMA - EMA to support establishment of the African Medicines Agency
7th February 2024EMA 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.
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EMA - New platform for collection of sales and use data of antimicrobials in animals
7th February 2024EMA 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.
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EMA - Transition to the Clinical Trials Information System (CTIS) by 31 January 2025
7th February 2024All ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025.
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EMA - Veterinary medicines: Highlights of 2023
7th February 2024On 24 January 2024 EMA published an overview of its key recommendations of 2023 regarding the authorisation and safety monitoring of veterinary medicines.
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FDA - GMP for APIs Used in Veterinary Medicinal Products
7th February 2024CVM GFI #286 (VICH GL60) - Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products Draft released and open for comments.
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FDA - Roundup, 6th February 2024
7th February 2024An at-a-glance summary of news from around the agency
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MHRA - updates on to how to notify the MHRA of changes to the PV System
7th February 2024Guidance updates on to how to notify the MHRA of changes to the PV System
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Union Health Ministry (India) notified revised rules under Schedule M of the Drugs and Cosmetics Rules, 1945
7th February 2024The 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.
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EMA - New Q&As on EU GMP Guide Annexe
2nd February 2024Annex 1: Manufacture of sterile medicinal products
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MHRA - two new UK Approved Bodies to certify medical devices
2nd February 2024MHRA announces two new UK Approved Bodies to certify medical devices
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EMA - Major update of the SME user guide
24th January 2024The European Medicines Agency (EMA) has released a major revision of its user guide for micro, small, and medium-sized enterprises (SMEs) in the pharmaceutical sector.
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EMA - Highlights CVMP 16-17 Jan 2024
24th January 2024Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-17 January 2024
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FDA - Roundup 23rd Jan 2024
24th January 2024An at-a-glance summary of news from around the agency.
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EMA - Human medicines: highlights of 2023
18th January 2024In 2023, EMA recommended 77 medicines for marketing authorisation. Of these, 39 had a new active substance which had never been authorised in the European Union (EU) before. Among these are a number of medicines that stand out due to their contribution to address public health needs or the innovation they represent.
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EMA - Meeting Highlights PRAC 8th - 11th Jan 2024
18th January 2024Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 January 2024
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FDA Roundup: 16th January, 2024
18th January 2024An at-a-glance summary of news from around the agency.
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MHRA - Roadmap towards the future regulatory framework for medical devices
18th January 2024Released 9th January 2024
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SFDA - PV Inspections Report 2023
18th January 20241st Jan 2023 to 31st Dec 2023
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A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium
9th January 202413th - 15th February 2024
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FDA - FDA Authorises Florida’s Drug Importation Programme
9th January 2024U.S. Food and Drug Administration have authorised Florida’s Agency for Health Care Administration’s drug importation programme under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
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MHRA - Regulatory Roadmap points the way ahead for new measures to support safe access to medical technology including AI and diagnostics
9th January 2024MHRA sets out new plans to protect patient safety and enable access without delay for UK patients to innovative medical technologies.
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EMA/FDA - Joint Q&A on quality development and good manufacturing practice for Priority Medicines (PRIME) and Breakthrough therapy (BT) designation applications
20th December 2023This Q&A provides medicine developers with guidance on how to address challenges associated with expedited product development, so that robust quality and manufacturing data packages will be available to support their application.
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EMA - Final version of HMA-EMA Big Data Steering Group's Multi-annual Artificial Intelligence Workplan 2023-2028
19th December 2023EMA are pleased to inform you that the final version of the HMA-EMA Big Data Steering Group's Multi-annual Artificial Intelligence Workplan 2023-2028 has been published.
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EMA - CTIS newsflash – 8 December 2023
15th December 2023This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
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EMA - Human Medicines Newsletter 175
15th December 2023Nov-Dec 23
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MHRA: GMP & GDP Certificates
15th December 2023Validity Period Extended
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MHRA: MHRA supports launch of Innovate UK’s first-of-its-kind initiative to fund new Regulatory Science and Innovation Networks
15th December 2023Applications are now open for academic institutions wishing to bid for funding to collaborate with others to establish new Regulatory Science and Innovation Networks (RSINs) in innovative sectors.
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EMA - Data Quality Framework for EU medicines regulation
14th December 2023EMA releases first version of their Data Quality Framework for EU Medicines Regulation.
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EMA - EU medicines agencies reflect on lessons learned from COVID-19
6th December 2023A joint report issued by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) reviews the Network’s response and highlights the main learnings for any future health crises.
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EMA - Implementation strategy for ICH M10
6th December 2023The EMA has issued their implementation strategy for ICH M10 – public consultation is open until until 31 January 2024.
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FDA - FDA Roundup, 5th December 2023
6th December 2023An at-a-glance summary of news from around the agency,.
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EMA - Consumption of antimicrobials in animals reaches lowest level ever in Europe
22nd November 2023European countries have substantially reduced sales of veterinary antibiotics, which translates into a lower risk of bacteria becoming resistant in people and animals.
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EMA - Small and Medium-Sized Enterprises Newsletter
22nd November 2023Issue 60
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FDA - FDA Roundup: 21 November, 2023
22nd November 2023An at-a-glance summary of news from around the agency
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MHRA - International Recognition Procedure Updates
22nd November 2023MHRA added guidance on the Eligibility Checker and submitting your Marketing Authorisation application, IRP Product Lifecycle & eCTD guidance for MAs and Lifecycle to the International Recognition Procedure pages of it's website.
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MHRA - MHRA launches online Eligibility Checker tool for applications via the new International Recognition Procedure (IRP)
22nd November 2023IRP is expected to further help bringing life-saving new medicines to UK patients from 1 January 2024
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MHRA - Performance Metrics
22nd November 2023Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments
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MHRA - Performance Metrics January 2023 – October 2023: Assessment of New Marketing Authorisation Applications and Variations
22nd November 2023MHRA performance - Assessment of New Marketing Authorisation Applications and Variations
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MHRA Blog - Antimicrobial resistance: How we’re supporting innovative solutions to a looming global health emergency
22nd November 2023World AMR Awareness Week (WAAW) is an annual global campaign from 18-24 November that raises awareness and understanding of antimicrobial resistance (AMR), a global health issue worsened by the misuse of antimicrobial agents such as antibiotics.
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Swissmedic - Interpretation of Annex 1
22nd November 2023This technical interpretation focuses on some of the most important main changes of the revision 2022 of Annex 1 and also covers aspects that were already included in the previous version of this guideline and that repeatedly gave rise to questions.
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EMA - Veterinary Papers Released for Public Consultation
16th November 2023Comments by 31st January 2024
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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2023
13th November 2023Meeting highlights
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EMA - CTIS newsflash
13th November 202310th November 2023
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EMA - Call for expression of interest for independent scientific experts to participate in the work of EMA’s Safety Committee
13th November 2023The European Commission is launching a selection procedure to appoint independent scientific experts to EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). Six experts will be appointed for a three-year mandate starting on 2 July 2024.
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EMA - Global regulators celebrate 10 years of strategic leadership and cooperation
13th November 2023This year marks the 10th anniversary of the International Coalition of Medicines Regulatory Authorities (ICMRA).
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EMA - Human Medicines Highlights Oct 2023
13th November 2023Issue 174
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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)
13th November 20236-9 November 2023
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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP)
13th November 20237-9 November 2023
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FDA - Benefit-Risk Assessment for New Drug and Biological Products
13th November 2023The FDA has published its final guidance on Benefit-Risk Assessment (BRA), which clarifies how these considerations factor into FDA's regulatory decisions.
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ICH - Assembly Meeting, Prague, Czech Republic, October/November 2023
13th November 2023The Assembly of the International Council for Harmonisation (ICH) met in-person on 31 October & 1 November 2023, in Prague, Czech Republic in parallel of meetings of 16 Working Groups, and preceded by meetings of the ICH Management Committee and the MedDRA Management Committee.
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MHRA Blog - The role of genetics in medicine safety
13th November 2023Dr Alison Cave, Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency (MHRA) highlights how genetics could play an important role in minimising the risk of adverse drug reactions (ADRs), and how the MHRA are working with partners across the system to make this a reality with their new Yellow Card biobank.
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