German Competent Authorities as Part of the Network of European Drug Regulators. PD Dr. Walter Schwerdtfeger

Transcription

1 German Competent Authorities as Part of the Network of European Drug Regulators PD Dr. Walter Schwerdtfeger

2 BfArM and PEI: General duties (on the basis of the Federal Health Office Succession Act, June 994 (BfArM); Establishment Act, July 97 (PEI); and successive development of legislation) performing legally specified tasks and tasks assigned to the authorities by the respective responsible Ministry supporting the Federal Government performing scientific research within own areas of responsibility informing stakeholders and the general public

3 Federal Drug Authorities - scope of responsibility PEI sera, vaccines (human and veterinary) blood preparations, blood components (genetically engineered), bone marrow preparations tissues and tissue preparations, allergens advanced therapy and xenogeneic medicinal products in vitro diagnostics (BVL medicinal products for veterinary use, except vaccines) BfArM any medicinal product not regulated by PEI or BVL narcotic drugs, psychotropic substances, precursors medical devices except in vitro diagnostics

4 PEI and BfArM: specific duties scientific advice approval of clinical studies participation in approval of clinical trials (veterinary vaccines) authorisation of medicinal products registration of homeopathic/anthroposophic and traditional herbal medicinal products batch release post-marketing activities including pharmacovigilance inspections monographs for EU- and national pharmacopoeias surveillance of legal commerce of narcotics medical devices: assessment of the medical and technical safety, vigilance

5 BfArM Federal Insitute for Drugs and Medical Devices (BfArM) Kurt-Georg-Kiesinger-Allee 7 Bonn Telefon: (08) 07 0 Telefax: (08) Research Council Communication, Press Office, Ombudswoman Project Management general aspects Acting Head Deputy EU, International Affairs Strategy and Planning QM/CM Controlling Sci. QA Administration Licensing Licensing Licensing Licensing 4 Licensing Scientific Services Pharmacovigilance Federal Narcotics Office Medical Devices Human Resources Validation Project Management Project Management Project Management Project Management Clinical Trials Risk Registration, Database, Terminology Control of Raw Materials Active Medical Devices Budget, Building Maintanance Facilites Management Simplified Procedures Gastroenterology Antiinfectives Anaesthesiology, Analgesics Herbals and Trad. Med. Products: Pharm. Assessment Scientific Advice Risk Assessment I Trade with Narcotics I and Safety Measures Non-Active Medical Devices Library Legal Affairs/ Fees Recording and Archiving Parallel Imports Endocrinology Oncology, Immunology, Hematology Genetic and Reproductive Toxicology Cardiolovascular System Dermatology, Otorhinolaryngology Ophtalmology Respiratory Tract Biometrics, Biostatistics. BE, BW, BA Neurology, Psychiatry Rheumatology, Radiology Pharm. Biotechnology, Biologicals, Quality Inspections Herbals and Trad. Med. Products: Clinical Assess. Homoepathics, Anthroposophics: Pharm. Assess. Homoepathics, Anthroposophics: Clin.Assess. Commissions Legal Affairs Pharmacopoeia Standard Registration Risk Assessment II Pharmacoepidemiology, Pharmacovigilance Centres Risk Assessment III OTC/POM Risk Communication Risk Assessment Procedures, Pharmacovigilance Inspections Trade with Narcotics II Narcotics Affairs for Pharmacists and Medical Doctors In-Vitro Diagnostics Quality Management and General Affairs Organisa-tional Issues Information Technology Internal Services Equal Opportunity Commissioner Chair of the Staff Committee Representatative for Disabled Employees Social Advice

6 PEI Research Co-ordinator President s Research Group Section Pr Retroelements President s Research Group Section Pr Transmissible Spongiform Encephalopathies President and Professor Vice President and Professor Unit L Management Support, Language Services Unit L Major Policy Issues Unit L Press and Information Office Unit L4 Quality Management Data Protection Representative Equal Opportunities Representative PEI-IVD Testing Laboratory for IVD Division Z Administration Division S Safety of Medicinal Products and Medical Devices Division EU Co-operation / Microbiology Division Virology Division Immunology Division 4 Veterinary Medicine Division Allergology Division 6 Medical Biotechnology Division 7 Haematology/ Transfusion Medicine Unit Z Personnel Unit S Pharmacovigilance I Section / EU Co-operation Biological Medicinal Products Section / Viral Vaccines Section / Immunochemistry Section 4/ Bacterial Vaccines and Immune Sera Section / Test Allergens Section 6/ Advanced Therapy Medicinal Products, Tissue Preparations Section 7/ Coagulation Products I Unit Z Finance and Procurement Unit S Pharmacovigilance II Section / Microbiological Vaccines Section / AIDS, New and Emerging Pathogens Section / Monoclonal and Polyclonal Antibodies Section 4/ Viral Vaccines I Section / Therapy Allergens Section 6/ Non-viral Gene Transfer Medicinal Products Section 7/ Coagulation Products II Unit Z PEI Gateway, Document Management Unit S Pharmacovigilance of Veterinary Immunological Products and Animal Welfare Section / Microbial Safety Section / Viral Safety Section / Morphology Section 4/ Viral Vaccines II Section / Clinical Allergology Section 6/ Tissue Engineering, Somatic Cell Therapeutics Section 7/ Batch Release Blood Products, Logistics Unit Z4 Technical Services Unit S4 Legal Affairs Section /4 Biostatistics Section /4 Molecular Virology Section /4 Therapeutic Vaccines Section ZT Animal Facilities Section /4 Recombinant Allergen Therapeutics Section 6/4 Non-vital Tissue Preparations, Xenogeneic Cell Therapeutics Section 7/4 Transfusion Medicine Unit Z Organisation and Information Technology Unit S Clinical Trials Section / Inspection Services for Biological Medicinal Products Section 6/ Viral Gene Transfer Medicinal Products Unit Z6 Occupational Safety & Health, Permits Unit Z7 Fee Collection Staff Representatives Council Chairperson Disabled Employees Representative Youth and Apprentice Representation Temporary Research Groups (NG) NG Experimental Allergy Models NG New Vaccination Strategies and Early Immune Responses NG Cellular Aspects of Pathogen Host Interactions

7 Basic budget figures (M ; official MoH budget 00) BfArM PEI revenue - fees - other total expenditure - staff - other total percentage revenue of expenditure 8 8

8 BfArM: Expenditures 00 expected total: 66. M

9 Staff BfArM scientists others VÄ = full-time equivalents

10 Staff PEI (scientists 40, others 400) Employees Positions

11 Salaries - how to attract qualified staff Marburger Bund TVÖD physician st year th year st year 6th year medical specialist st year 4.90 th year 600 st year. 0th year 4.70 senior physician st year th year 6.0 st year.68 th year.80

12 What is expected fulfill duties correctly and within legal timeframes decide using consistent, transparent and plausible criteria provide state of the art scientific advice communicate openly charge fair fees give drug safety highest priority monitor standards of own performance, participate in benchmarking strive towards improving regulatory fundament participate in official and scientific networks perform task-related scientific research

13 What is necessary build up clear operative structures assign unequivocal responsibilities have concise SOPs for all relevant tasks and procedures establish high-performance IT systems motivate staff think twice when selecting senior staff keep in mind that patients, doctors, industry and authorities have closely related interests

14 What is fatal being unaware of current safety issues neglecting safety-related findings when taking decisions ignoring the need of continuous performance controlling thinking you are the best anyway

15 CHMP (co-)rapporteurships, BfArM DK ES FR NL SE UK DE

16 RMS in DCP/MRP-procedures, BfArM DCP/MRP RMS-ships DE NL UK 000 DK AT BE BG CY CZ DE DK EE EL ES FI FR HU IE IS IT LI LT LU LV MT NL NO PL PT RO SE SI SK UK

17 CHMP (co-)rapporteurships, PEI-regulated products [hum.] PEI = (Co) Rapp ca. 0 % advanced therapeutics C. advanced therapeutics R. antibodies+ig R. antibodies + IG C.G blood products R. blood products C. vaccine R. vaccine C DE (=PEI) BE DK ES FI FR IE IT NL NO SE UK HU AT PL

18 CVMP (co-) rapporteurships, PEI-regulated products [vet.] Co-Rapporteur Rapporteur DE (PEI) 0 BE DK 7 ES 0 FI 4 FR IE 6 IT 0 NL NO UK HU PT EL SE AT

19 RMS in MRP/DCP-procedures, PEI-regulated products [hum.] allergene immunoglobulins (polykonale AK) monoclonal antibodies 0 blood products combination vaccine 40 viral vaccine 0 bacterial vaccine DE (=PEI) BE DK FR IT NL SE UK AT

20 RMS in MRP/DCP, PEI-regulated products [vet.] MRP DCP DE (PEI) BE CZ DK ES FR 6 HU IE IT NL 7 SK UK

21 Participation of NCAs in EMA activities, 009 Number of meeting days total EMA 6.6 Belgium FAMHP: France AFFSAPS: 70 AFFSA: Germany BfArM: PEI: BVL: 6 88 Sweden MPA: UK MHRA: 74 VMD: 4 848

22 Commitments to NCAs (total, M ) Germany France UK

23 PEI: Goals keep research focussed to task-related topics keep position in regulation speed up licensing procedures increase efforts to improve IT systems request external evaluation provide to development of advanced therapies

24 BfArM: Goals further improve position in regulation speed up licensing procedures improve quality of assessment reports increase efforts to improve IT systems strive towards improving tools and procedures of pharmacovigilance improve position in research focus on neurodegenerative diseases expand cooperation with academic environment increase number of research-active senior staff generally: apply any available option to attract highly qualified staff