Accession preparation - Phasing-in Reinforcing patient safety in - PowerPoint PPT Presentation

Accession preparation - Phasing-in Reinforcing patient safety in Europe 14-15 June 2011 Zagreb, Croatia Presented by: Tony Humphreys Head of Regulatory, Procedural and Scientific Committee Support An agency of the European Union

EMA London European Commission Brussels 1 Accession preparation - Phasing-In

 Operational roles and responsibilities within an enlarged EU  Impact on National MAs as of Accession  Expected Contribution to the Network  Facilitating Operation of the Network 2 Accession preparation - Phasing-In

10. Health Technology 1. Animal Testing Assessment GLP 1 10 9. HCPs Prescribing Re-imbursement 2. Clinical Trials Pricing GCP 2 9 substitution 3. Compassionate NCA 8. Independent Use Programme 8 3 Information Sources 4. Production Facilities 7 4 7. Advertising Controls Active Substance • Rx and Non Rx Finished Product • GMP 6 5 6. Distribution Wholesalers/pharmacies Parallel imports, Inspections 5. National MA +ve risk/benefit / SPC label +leaflet 3 Accession preparation - Phasing-In

Health Technology Animal Testing Assessment GLP HCPs Prescribing EPARs GLP WP Re-imbursement Clinical Trials CHMP SAWP pricing ARs GCP EudrACT substitution GCP WP SAWP PhVig WP, Eu.vig DB EudraVig CHMP Compassionate Independent EudrACT Use Programme CU Op EudraPharm Information Sources GMP IWG, Eudra GMP CP DB GMP IWG Production Facilities CMD(h) Advertising Controls GDP IWG QSE WP Active Substance • Referrals Rx and Non Rx Finished Product • GMP Distribution Wholesalers/pharmacies National MA Parallel imports, Inspections +ve risk/benefit / SPC label +leaflet 4 Accession preparation - Phasing-In

Impact on National MAs as of Accession Nature of medicinal product concerned = vast majority stay national = “update in compliance with Acquis” exercise  Certain product types suitable for MR/ DCP = will lead to National MA = but linked and harmonised  Certain product types obligatory CP 5 Accession preparation - Phasing-In

Access to Medicines NAS Mandatory Scope Auto-im m une disease and Other immune dysfunctions Cancer Neurodegenerative AI DS disorder Viral - Recom binant DNA technology diseases Diabetes - Controlled gene expression - Monoclonal AB Orphan Med Prod NAS / “know n” AS Reg. 2 3 0 9 / 9 3 Reg. 7 2 6 / 2 0 0 4 6 Accession preparation - Phasing-In

Access to Medicines Optional Scope Art. 3(2) of Regulation (EC) No 726/2004 Art. 3(2)(a) Art. 3(2)(b) Significant Innovation Interest of New Active Patients at Substances -Therapeutic Community &/or OR Level Scientific &/or Technical “known” AS 7 Accession preparation - Phasing-In

Impact on National MAs as of Accession ATMPs Food Supple- Hom eo- Trad Chem ical Biologicals Biologicals Medical m ents pathics Herbals ( trad) ( high tech) Devices Active Substances National National National National National National National National MRP / DCP MRP / DCP MRP / DCP - - - - - -- - - - - - - - -- - CP CP CP CP 2 0 1 1 HMPC Hom eopathic 2 0 1 2 Med prod W P “hospital HMA exem ption” 8 Accession preparation - Phasing-In

Levels of harmonisation drive impact A. Centralised Medicinal Product = No national equivalent MA allowed = Central MA effective as of Accession B. Community Referral Procedure with partial / complete SPC harmonisation = “expected” to be implemented into National MA C. MRP / DCP Medicinal Products = “invited” to be implemented into National MA (repeat use procedure) 9 Accession preparation - Phasing-In

National MAs: Continued Independence of action? It depends… . • MRP / DCP fully linked for all regulatory actions • Quality defects; Emerging safety issues rapid communication through network NuI / Rapid Alert System (RAS) • Pharmacovigilance safety actions ; suspension triggers Art. 107 Procedure takes issue to EU level • Community Interest Art. 31 referrals impacts on national MA • NCA can take interim suspension of use action for all products regardless legal basis approval 10 Accession preparation - Phasing-In

National MAs Continued Independence of Action? Case studies Art. 107 – Ketoprofen gel = phototoxicity Nimesulide = Hepatotoxicity Art. 31 – Dextropropoxyphene = risk of accidental overdose and death 11 Accession preparation - Phasing-In

Expected Contribution to the Network Legislatively Mandated One Member / Managem ent Board Managem ent Board One Alternate per Member State Role: Rapporteur/ Com m ittee for Herbal Com m ittee for Veterinary Com m ittee for Herbal Com m ittee for Veterinary Medicinal Products Medicinal Products Peer Reviewer/ Voting Member Medicinal Products Medicinal Products ( HMPC) ( CVMP) ( HMPC) ( CVMP) EMEA EMEA Members of the committees and experts Secretariat Secretariat responsible for evaluating medicinal Com m ittee for Orphan Com m ittee for Orphan Paediatric Com m ittee products shall rely on the scientific Medicinal Products Paediatric Com m ittee Medicinal Products ( PDCO) ( COMP) ( PDCO) evaluation and resources available to ( COMP) national marketing authorisation bodies. Each competent national authority shall Pharm acovigilance Com m ittee for Hum an Com m ittee for Pharm acovigilance monitor the scientific level and Com m ittee for Hum an Com m ittee for Risk Assessm ent Medicinal Products Advanced Therapies Risk Assessm ent Medicinal Products Advanced Therapies independence of the evaluation carried Com m ittee ( CHMP) ( CAT) Com m ittee ( CHMP) ( CAT) ( PRAC) out and facilitate the activities of ( PRAC) nominated committee members and experts. Member States shall refrain from giving committee members and experts any instruction which is incompatible with their own individual tasks or with the CMDh CMDv HMA tasks and responsibilities of the Agency. CMDh CMDv HMA 12 Accession preparation - Phasing-In

Working Party Constellation QSE standards Evaluation of Pharmacogenomics Biosimilars SAG Medicines Urology diagnostics Biostatistics SAG Radiopharmaceuticals CVS Blood Prod SAG Respiratory SAG QWP * CVS Patients & Neurology Gastroenterology Consumers Cardiovascular SAG HIV / SWP * CHMP Vaccines Antiviral CNS PhVig * SAG Cardiovascular Rheumatology Psychiatry BWP * Immunology Sci Adv Geriatrics SAG Infectious Diabetes Pharmacokinetics * 1 / MS Diseases representation Oncology SAG 13 Accession preparation - Phasing-In Oncology

MS Co-ordination structures Mutual Recognition and De-centralised Procedures MRFG CMDh < 1 9 9 5 > < 2 0 0 5 > ( h/ v) ( h/ v) Inspections Clinical Trials GMP I W G CTFG GCP I W G GDP I W G 14 Accession preparation - Phasing-In

Communication system EudraData Warehouse EudraNet EudraLink ESubm issions Com m unication P S Eudra- H U A vigilance R B M M A EURS EU Telem atics C I European O Review S V System I S EudraCT G I I L Databases o A N N EUTCT C S Controlled E EudraPharm EudraGMP term s 15 Accession preparation - Phasing-In

Financing the system 2 3 .1 % EU Subsidy ( 2 0 0 9 ) PDCO SAWP COMP CHMP PRAC HMPC CAT CMD( h/ v) • Staff • Meeting facilities FEES • Members National / Experts MR / DCP travel exp 50% 50% • EU Rapporteurs telematics (NCAs) 16 Accession preparation - Phasing-In

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