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© Safeguarding public health Meet the Regulators MHRA, London 13 April, 2011 LRMN/ MHRA MEETING
© ATMPs - the regulatory setting Marketing Authorisation centralised licence (MA) (CAT) EMA Commercial Clinical Trials Phase I, II, III Pre- clinical Safety Clinical Trials national licence (CTA) NCA EUTCD or Blood Directive Donation, procurement & testing (processing) Unlicensed (Hospital Exemption / Specials) Cert. of Quality & non-clinical data EMA GP GMP MIA(IMP) GMP MIA GLP Dossier Transplants or Transfusions Processing, preservation, storage, distribution GP Borderline – classification of product: medicinal product? Dossier Advice and guidance NCA / EMA
© Presentation Outline Abbreviation glossary ATMPs – the regulatory setting Useful links
© Abbreviation Glossary ATMP- Advanced Therapy Medicinal Product (GT, SCT, TEP) CAT- Committee for Advanced Therapy EMA- European Medicines Agency EUTCD- EU Tissue and Cells Directive (2004/23/EC) GP- Good Practice (Quality System under Blood & EUTCD) GT- Gene Therapy NCA- National Competent Authority (e.g. MHRA) SCT- Somatic Cell Therapy TEP- Tissue Engineered Products
© Inspectorate contact with ATMP Industry Regulatory advice on manufacturing : -Verbal -Written -Meetings – GMP only / with CTU / with Licensing Division Inspections: -Hospital Exemption - Manufacturer’s Specials -CT - MIA(IMP)- Full - MIA
© Inspectorate contact with ATMP Industry Formal classification advice: -Available from EMA and via MHRA website -MHRA’s centralised process been in place for 3 years: Year No. ·08/09: 8 ·09/10: 24 ·10/11: 13 -System been well received -Advice requests received on a broad range of product types
© Inspectorate contact with ATMP Industry DH initiatives -Stem Cell Tool Kit Commission / ATMP Regulation : -Article 5 (Annex 2) -Article 25 (Report and review)
© Useful links EMA – What’s new in Inspections: -http://www.emea.europa.eu/Inspections/WhatsNew.html Commission ‘Latest News on Pharmaceuticals’: -http://ec.europa.eu/health/documents/new_en.htm GMP Volume 4: -http://ec.europa.eu/health/documents/eudralex/index_en.htm
© Scientific Advice (National) for ATMP present Safeguarding public healthCTMPGTMP (to Mar) 20
© 1. Characterisation and Impurities 2. Mechanism of Action and Potency Testing 3. Demarcation of Drug Substance and Drug Product Recurring issues for CTMP:
© Safeguarding public health Advanced Therapy Medicinal Products: EU procedures LRMN 13 April 2011 Patrick Celis, PhD CAT Secretariat, EMA, London
© CLASSIFICATION EVALUATION CERTIFICATION Tasks of the CAT Tasks of the Committee for Advanced Therapies (CAT) Scientific Advice Support to PDCO Support to CHMP / COMP Interaction with stakeholders Publications, Guidelines
© ATMP Evaluation procedure ATMPs will follow the Centralised procedure (mandatory scope) single MA (marketing authorisation) for entire EU: 210 Day procedure Evaluation by two independent (Rapp/CoRapp) teams from CAT All scientific discussion and adoption of key documents at CAT ATMP evaluation procedure builds on full transparancy between CAT and CHMP to avoid divergent views. * CHMP = Committee for Human Medicinal products. Responsible for opinion on centralised MAA + post-authorisation follow-up / Pharmacovigilance
© Classification procedure Incentive Open to all applicants Scientific Recommendation from CAT on the Regulatory Classification of their ATMP 60-day procedure (often shorter) Publication of summary information on classification Procedure reviewed (simplified) following experience in 2009
© Classification procedure 44 applications received so far 42 finalised Within 60 days 4 out of 42: 1 month clock stop for clarifications (Status April 2011) GTMP Not ATMP ATMP TEP CTMP
© Certification procedure Only for SMEs Scientific evaluation by CAT of -(early) quality / development data (Module 3) -(early) non-clinical data (Module 4) 90 day procedure Evaluation to the scientific standards of a MAA -The SME applicant will always received the evaluation report (and List of issue for future consideration) -If positive evaluation: Certificate by EMA 1 Certification procedure finalised (May 2010)
© Source: CAT monthly report March 2011
© Thank you for your attention Dr Patrick Celis (CAT Secretariat) Queries: ATMP Microsite: neral/general_content_ jsp&murl=menus/regulations/r egulations.jsp&mid=WC0b01ac e0 neral/general_content_ jsp&murl=menus/regulations/r egulations.jsp&mid=WC0b01ac e0
© CAT workprogramme Useful links Developers CAT MHRA information on ATMPs edicinalproducts/index.htm EMA information on Advanced Therapies ation/general/general_content_ jsp&murl=menus/reg ulations/regulations.jsp&mid=WC0b01ac e0&jsenabl ed=true European Commission’s Directorate for public health and risk assessment therapies/index_en.htm
© Useful links Developers CAT CAT Work programme ork_programme/2010/11/WC pdf CAT Interested Parties and Focus Group Non-Clinical development ation/general/general_content_ jsp&murl=menus/reg ulations/regulations.jsp&mid=WC0b01ac058009a23d&jsenabl ed=true
© Contacts for further information MHRA Dr Gopalan Narayanan - Mr Ian Rees - Dr Elaine Godfrey - EMA CAT Secretariat Dr Lucia D’Apote -
The Advanced Therapy Medicinal Products Regulation from the European Medicines Agency (EMEA)'s perspective Nathalie Rampal Olmedo EMEA – Directorate –
1 6 th European Patients Rights Day The EMA Geriatric Medicines Strategy and the empowered aging patient Francesca Cerreta EMA (European Medicines Agency)
ICORD 2006 Kerstin Westermark Md, PhD, Assoc. prof. COMP Chairperson.
Current trend of regulation, approval and development of advanced therapy medicinal products in Europe Balázs Sarkadi, Hungarian Academy of Sciences, Budapest,
Author: Bente Jessen Chair EFPIA China Regulatory Network * Date: 05/04/2016 * China EU Pharmaceutical Forum EU System for Marketing Authorisation.
DMF Procedures and Communication between API, FP Manufacturers and Regulatory Authorities Jean-Louis ROBERT National Health Laboratory L – 1011 LUXEMBOURG.
Special populations- What makes them so special? AGAH Association for Applied Human Pharmacology Annual meeting 2004 Berlin 29. Februar 2004 Birka Lehmann.
Introduction to PPDs Regulatory requirements and rationale.
DMF Procedures and Communication between API, FFP Manufacturers and Regulatory Authorities Jean-Louis ROBERT National Health Laboratory L – 1011 LUXEMBOURG.
Zoe Whale / Lynette Lane GCP Facilitators, NISCHR CRC Good Clinical Practice in Research Clinical Trial Regulations.
Transatlantic Administrative Simplification Workshop European Preparatory Roundtable Suzette Kox EGA Senior Director Scientific Affairs.
© Safeguarding public health Expert Group on Innovation in the Regulation of Healthcare products Adaptive Licencing workshop at the Wellcome Trust October.
1 Advanced Therapy Medicinal Products April 18, 2012
Catapult is a Technology Strategy Board programme Clinical development of cell based therapies in the UK Natalie Mount PhD Chief Clinical Officer Cell.
© Safeguarding public health UK implementation of the ATMP regulation – and how it impacts on hospital pharmacies Sharon Longhurst Senior Pharmaceutical.
European Parliament Advanced Therapies Hearing May 11, 2006 Advanced Therapies The proposed EU regulation from the viewpoint of a Pharmaceutical company.
International conference Quality of Active Pharmaceutical Ingredients Hyderabad, September 2009 API Inspections: the EDQM experience – 7 September.
EU System for Marketing Authorisation China/EU Pharmaceutical Industry Forum, 16 May 2015, Shanghai Anette Hjelmsmark, EFPIA China Regulatory Network,
The EU Eco-Management and Audit Scheme (EMAS). Voluntary environmental management tool operative since 1995 What is EMAS? Aim Continual improvements in.
An agency of the European Union Presented by: Alexios Skarlatos European Medicines Agency – Head of Product Information Quality Overview of the EU regulatory.
Health and Consumers Health and Consumers Regulation of Food Additives in the EU MeatCoat research programme 27 May 2014 Wim Debeuckelaere European Commission,
Compassionate use programs and the European regulatory system Filip Josephson M.D., Ph.D. Clinical Assessor.
I&EHL: EU Pharmaceutical Law André den Exter
An agency of the European Union Kehittyneen terapian lääkevalmisteiden (ATMP) myyntilupaprosessi ja CAT Fimea GLP-keskustelupäivä Paula Salmikangas.
Update on Transparency Obligations Martin Reisner Junior Adviser, Transparency ENTSOGs Transparency Workshop Brussels – 11 September 2012.
An agency of the European Union Presented by: Emer Cooke and Truus Janse-de Hoog Update on Transparency Progress report from HMA/EMA TF on Transparency.
WHO PROGRAMME FOR STRENGTHENING NATIONAL REGULATORY AUTHORITIES IN THE AREA OF VACCINE WHO Technical Briefing Seminar on Essential Medicines and Health.
Regulatory Framework Leigh Shaw, Director.
Clinical Trial Review and Approval: New Regulations and their implications Siddika Mithani, Ph.D Clinical Trials & Special Access Programme Therapeutic.
European Commission Enterprise and Industry # European Standardisation: Proposal for a Regulation Presentation to IMCO – 5 October 2011 European Commission.
An agency of the European Union Orphan Medicine Designation and development in Rare Diseases Segundo Mariz Scientific Administrator Orphan Medicines Office.
An agency of the European Union Enpr-EMA European Network of Paediatric Research at the European Medicines Agency Background information Irmgard Eichler,
Research Policy & Management RACD Medicines and Healthcare products Regulatory Agency (MHRA) Statutory Good Clinical Practice (GCP) Inspection of Cardiff.
Registration in Europe Current situation and future outlook Thomas K ü rner, M.D. Nippon Boehringer Ingelheim Co., Ltd.
Protecting and promoting the interests of patients and the public in health research 1 MHRA / LRMN event The UK regulatory landscape in 2013 New GTAC arrangements.
The Changing Face of EU Legislation Is the EU moving towards the FDA model of pharmaceutical legislation? By Robert Smith Director.
Development and implementation of Guidance Documents – the role of the European Commission Karin Nienstedt - DG SANTE / E3 ECCA-ECPA Conference,
Paediatric Worksharing CMDh participation Work-sharing in Art 45 and 46 procedures Experiences in Art 29 procedures Presidency meeting 29 September 2011.
I farmaci innovativi in una prospettiva europea Giuseppe M.C. Rosano, MD, PhD Cardiovascular and Cell Sciences Research Institute, St George's University.
December 2005 EuP Directive : A Framework for setting eco-design requirements for energy-using products European Commission.
Slide 1 November 2008 Name Sarah Morgan © Crown copyright 2005 Pharmacovigilance Working Party - Role and future perspective Sarah Morgan Medicines and.
Adaptive study design in early phase research: The regulatory perspective Dr Martin O’Kane April 2013.
EPAA Annual conference November Regulatory acceptance of alternative approaches for pharmaceuticals Jean-Marc Vidal Safety & Efficacy of Human Medicines.
Implementation Activities for QbD: EU PAT Team WCBP CMC Strategy Forum Washington, 19 July 2010 Kowid HO Afssaps, France.
Information outcomes from regulatory processes Regine Lehnert Training workshop: Regulatory requirements for registration of Artemisinin based combined.
1 EU Policy in the field of Organ Donation and Transplantation Media Seminar - EU Health Journalist Prize Brussels, 29 October 2009 Anna Pavlou European.
Advanced Therapy Medicinal Products - ATMPs - A case study in health economics: ChondroCelect 110/17/2015 ATMP - D.Dubois.
An agency of the European Union The SME Office at the European Medicines Agency Constantinos Ziogas SME Office, Stakeholder & Communication Division, European.
The New(ish) European Pharmacovigilance Legislation Jacquelyn Awigena-Cook Associate Director, Head PV Policy ISCT Satellite GRP Workshop 27 January 2013.
Slide 1 Encouraging innovation: the regulators perspective Bringing the best to healthcare through partnership and innovation IPHA, 1 st December 2011.
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