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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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EDQM - Contribute to shaping the future EDQM strategy – Stakeholder survey
30th November 2022EDQM - Contribute to shaping the future EDQM strategy – Stakeholder survey
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EMA - New Quality Innovation Expert Group (QIG) supports medicine innovation
30th November 2022EMA has established a Quality Innovation Expert Group (QIG) to support innovative approaches for the development, manufacture, and quality control of medicines for the benefit of patients in the European Union (EU). These include, but are not limited to, new technologies, digitalisation, novel materials and novel devices, in line with the priorities highlighted in EMA’s Regulatory Science Strategy to 2025.
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ICH - Press Release: ICH Assembly Meeting, Incheon, Republic of Korea, November 2022
30th November 2022ICH - Press Release: ICH Assembly Meeting, Incheon, Republic of Korea, November 2022
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MHRA - Consultation to help influence how MHRA communicate with you
30th November 2022Consultation with healthcare professionals: please complete our consultation to help influence how MHRA communicate with you
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MHRA - Drug Safety Update November 22
30th November 2022MHRA - Drug Safety Update for Nov 2022 updated.
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MHRA Blog - Increasing the efficiency of your clinical trial authorisation (CTA) application and reducing the need for subsequent substantial amendments
30th November 2022MHRA Blog Post - Increasing the efficiency of your clinical trial authorisation (CTA) application and reducing the need for subsequent substantial amendments
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UKRI - launch a new opportunity for Centres for Doctoral Training (CDTs) in artificial intelligence (AI)
30th November 2022UKRI to launch AI CDT call.
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EMA - Consultation - concept Paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice for medicinal products – Computerised Systems
28th November 2022EMA Consultation Concept Paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice for medicinal products – Computerised Systems.
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EMA - Consultation - draft guideline on the development and data requirements of potency tests for veterinary cell-based therapy products and the relation to clinical efficacy
28th November 2022EMA Consultation Draft guideline on the development and data requirements of potency tests for veterinary cell-based therapy products and the relation to clinical efficacy.
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EMA - Consultation - reflection paper on criteria to be considered for the evaluation of new active substance (NAS) status of biological substances.
28th November 2022EMA Consultation The European Medicines Agency has published for public consultation a reflection paper on criteria to be considered for the evaluation of new active substance (NAS) status of biological substances.
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ICH - The ICH E19 Introductory Training Presentation is now available on the ICH website
16th November 2022The ICH E19 Introductory Training Presentation is now available on the ICH website
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MHRA - Process for approving Manufacturing Authorisations or API Registrations in relation to unlicensed Cannabis-Based Products for Medicinal Use
16th November 2022Several companies have contacted the MHRA regarding cannabis-based products for medicinal use. This blog provides information on what authorisations are required in order to MHRA Manufacturing Licence Application manufacture within this sector of the pharmaceutical industry.
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WHO - WHO releases first data on global vaccine market since COVID-19
16th November 2022This is the first report to capture the implications of COVID-19 for vaccine markets.
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Access Consortium Good Manufacturing Practice (GMP) Statement
15th November 2022MHRA Notice Access Consortium Good Manufacturing Practice (GMP) Statement Published 15 November 2022
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EMA - Human Medicines Highlights Newsletter
15th November 2022EMA - Human Medicines Highlights Newsletter, Issue 163 (Nov 22) released.
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EMA - ICH Guideline and Template for Consultation
15th November 2022ICH M11 guideline (Step 2b), ICH M11 technical specification (Step 2b) and ICH M11 template (Step 2b) - open for consultation.
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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2022
15th November 2022EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2022
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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-10 November 2022
15th November 2022EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-10 November 2022
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MHRA - Information about procurement at the Agency
15th November 2022Procurement at MHRA - Information about procurement at the Agency and how they are improving procurement opportunities for small and medium-sized enterprises.
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MHRA - Return to International GMP Inspections
15th November 2022MHRA - Return to International GMP Inspections
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EDQM - All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 34.4 is 31 December 2022.
19th October 2022All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 34.4 is 31 December 2022.
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EMA - High-quality data to empower data-driven medicines regulation in the European Union
19th October 2022High-quality data to empower data-driven medicines regulation in the European Union.
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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2022
19th October 2022Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2022
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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 4-6 October 2022
19th October 2022Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 4-6 October 2022
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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 September 2022
19th October 2022Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 September 2022
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ICH - Q5A(R2) draft Guideline on Viral Safety Evaluation of Biotechnology Products reached Step 2
19th October 2022The ICH Q5A(R2) draft Guideline on Viral Safety Evaluation of Biotechnology Products reached Step 2 of the ICH process on 29 September 2022.
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MHRA - Consultation on how MHRA communicate with healthcare professionals to improve medicines and medical devices’ safety
19th October 2022Consultation on how MHRA communicate with healthcare professionals to improve medicines and medical devices’ safety. Consultation description The MHRA is reviewing its approach to engagement with healthcare professionals to improve the safety of medicines and medical devices. We want to ensure that healthcare professionals are receiving actionable information and guidance on safe use of medicines and medical devices that they can take into their working practice, providing timely advice to patients. We need to improve the way we communicate with healthcare professionals. We want to hear from you to enable us to transform how we communicate with you and how we work together on our common goal of greater patient safety. Your Participation You can participate in this consultation anonymously but if you choose to provide your email address, we will add you to our mailing list to offer you future opportunities to hear about or get involved in our work. This questionnaire will take approximately 20 minutes to complete, or longer if you wish to offer additional comments. Please note that you do not have to answer every question and compulsory questions are clearly marked. Ways to respond Respond online
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MHRA - MORE Registrations - user reference guide A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents.
19th October 2022MORE Registrations - A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents.
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MHRA - Mental health funding of £1.8m welcomed by MHRA and NICE to explore regulation of digital mental health tools
19th October 2022Mental health funding of £1.8m welcomed by MHRA and NICE to explore regulation of digital mental health tools
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MHRA - Software and AI as a Medical Device Change Programme
19th October 2022Software and AI as a Medical Device Change Programme
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MHRA - Unique opportunity for healthcare professionals to influence future MHRA safety communications and safety reporting systems
19th October 2022Unique opportunity for healthcare professionals to influence future MHRA safety communications and safety reporting systems
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MHRA - annual accountability review minutes
19th October 2022The minutes of the ministerial annual accountability review of the Medicines and Healthcare products Regulatory Agency (MHRA).
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MHRA - Quarterly Summary Reports added to Medical Device Guidance
29th September 2022Quarterly Summary Reports added to Medical Device Guidance
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MHRA - Advertising and Promotion Section added to NIMAR
29th September 2022MHRA have added an 'Advertising and Promotion' Section added to NIMAR
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MHRA - first new UK Approved Body to certify medical devices since Brexit appointed
29th September 2022MHRA appoints first new UK Approved Body to certify medical devices since Brexit
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EC - Adoption of revised Annex VI to Regulation (EU) No 536/2014 (Clinical Trials Regulation, CTR)
28th September 2022The European Commission (EC) have adopted the revised Annex VI to Regulation (EU) No 536/2014 (Clinical Trials Regulation, CTR)
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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2022
28th September 2022EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2022
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EMA - Veterinary Medicines Regulation Highlights.
28th September 2022The latest edition of the Veterinary Medicines Regulation Highlights.
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EMA - biosimilar medicines approved in the European Union (EU) are interchangeable
28th September 2022EMA and the Heads of Medicines Agencies (HMA) have issued a joint statement confirming that biosimilar medicines approved in the European Union (EU) are interchangeable with their reference medicine or with an equivalent biosimilar.
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FDA - Answers to GCP Questions
28th September 2022FDA have published an Excel sheet of answers to some GCP questions.
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MHRA - Updated CAPA Guidance
28th September 2022MHRA have updated the CAPA guidance PDF on 27th September.
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PIC/S - Publication of revised PIC/S Annex 1
28th September 2022Publication of revised PIC/S Annex 1 The revised Annex 1 to the PIC/S GMP Guide on the manufacture of sterile products has been published and will enter into force on 25 August 2023, except for point 8.123 which is postponed until 25 August 2024. The date of entry into operation is aligned with that of the revised EU Annex 1, which is identical to PIC/S Annex 1 (with some very minor editorial differences).
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EDQM - Call for experts: join the Ph. Eur. network
14th September 2022EDQM - Call for experts: join the Ph. Eur. network
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EMA - Event Summary
14th September 2022EMA - Event Summary on Workshop on the guidance on the protection of personal data and commercially confidential information (CCI) in documents submitted or uploaded via CTIS
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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 September 2022
14th September 2022EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 September 2022
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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August – 1 September 2022
14th September 2022EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August – 1 September 2022
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FDA - Computer Software Assurance for Production and Quality System Software
14th September 2022Draft Guidance has been released on Computer Software Assurance for Production and Quality System Software.
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MHRA - new conflicts of interest code of practice for independent advisors
14th September 2022MHRA - new conflicts of interest code of practice for independent advisors
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MHRA - Guidance on Medical devices: software applications (apps)
14th September 2022MHRA - Guidance on Medical devices: software applications (apps). Added - 'Appendix 4 – Field Safety Warnings and End-of-Life notification'
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MHRA - Summary of responses to consultation - new Code of Practice for the Expert Advisory Committees
14th September 2022MHRA - Summary of responses to consultation - new Code of Practice for the Expert Advisory Committees
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EMA - Comments received on ICH guideline Q14 on analytical procedure development
8th September 2022EMA have published an overview of comments received on ICH guideline Q14 on analytical procedure development
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EMA - Comments received on ICH guideline on Q2(R2) Validation of analytical procedures
8th September 2022The EMA have published an overview of the comments received for on ICH guideline on Q2(R2) Validation of analytical procedures.
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EMA - Key performance indicators (KPIs) to monitor the European clinical trials environment
31st August 2022This report provides an overview of Key Performance Indicators (KPIs) related to the implementation of the CTR. The Clinical Trials Regulation Metrics report is published on a monthly basis starting in May 2022.
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FDA - Draft Guidance on Charging for Investigational Drugs Under an IND
31st August 2022Charging for Investigational Drugs Under an IND Questions and Answers - Guidance for Industry DRAFT GUIDANCE
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EMA - Accelerating Clinical Trials in the EU: publication of 2022-2026 workplan
30th August 2022The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the PDF icon 2022-2026 workplan of the initiative Accelerating Clinical Trials in the EU (ACT EU).
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FDA - Q9(R1) Quality Risk Management (Draft Guidance Document)
30th August 2022Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries. In the pharmaceutical sector, the principles and framework of ICH Q9, coupled with the official ICH training material that supports this guideline, are instrumental in enhancing the application of effective quality risk management by industry and regulators. The importance of quality systems has been recognized in the pharmaceutical industry, and it is evident that quality risk management is a valuable component of an effective quality system.
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MHRA Blog - Innovation, Quality & Transparency – a Compliance Team 1 Perspective
30th August 2022There has been much discussion of late between regulators and industry on how we can ensure that patients and the public get new medicines as quickly as possible - all the way from development to regulatory approval - while still ensuring they are safe, effective and of the required quality.
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OECD - Advisory Document of the Working Party on Good Laboratory Practice on Quality Assurance and GLP
30th August 2022OECD - July 2022 Advisory Document of the Working Party on Good Laboratory Practice on Quality Assurance and GLP
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OECD - Position Paper on Quality Improvement Tools and GLP
30th August 2022OECD - July 2022 Position Paper on Quality Improvement Tools and GLP
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MHRA - Decommission of eSUSAR
5th August 2022The MHRA is retiring the eSUSAR website in favour for Individual Case Safety Reports (ICSR) Submissions - providing users a more robust, stringent, and transparent way of expediting suspected unexpected serious adverse drug reactions (SUSARs) from Clinical Trials of Investigational Medicinal Products.
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