Federal Agency for Medicines and Health Products

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1 Federal Agency for Medicines and Health Products FAMHP Active partner in the EU regulatory framework Supporting innovative drug development Greet Musch BRUSSELS, 9 September 2017

2 1. Strategy of the FAMHP (1/2) The FAMHP: mid-size agency with full competencies (scientific advice, clinical trials, marketing authorisations, vigilance, inspections of medicines for human and veterinary use) Significant investment in the EU regulatory framework at the regulatory, scientific, policy-making level - 35 delegates at EMA/the HMA - 70 scientific internal experts: multidisciplinary, international - expanded database of 800 external experts Special focus on access to innovation - Unmet Medical Need (UMN) and link with Health Technology Assessment (HTA) - medical devices, cells and tissues 2

3 1. Strategy of the FAMHP (2/2) UMN EU Commission HMA working group Access to innovation) Clinical trials - EU CTR coordination group (EU Commission, EMA, the HMA) - the CTFG, Expert group on clinical trials - EU Network training Centre National Innovation Office SAWP (multinational assessment teams) CHMP (Prime), the PDCO, CAT and PRAC Spearheads - Vaccines - Early Phase Development 3

4 2. Focus on early access to innovation: clinical trials Approved Trials ( ) per therapeutic area: # trials BE, EU 12% of the trials in EU are performed in BE 2500 Therapeutic area - BE, EU total (# clinical trials) 22% Phase I trials 2000 Oncology, CNS, viral diseases Anesthesia and Analgesia [E03] Dentistry [E06] Diagnosis [E01] Equipment and Supplies [E07] Investigative Techniques [E05] Surgical Procedures, Operative [E04] Therapeutic techniques [E02] Biological Phenomena [G16] Bones and nerves physological processes [G11] Cell Physiological Phenomena [G04] Chemical Phenomena [G02] Circulatory and Respiratory Physiological Phenomena Digestive System and Oral Physiological Phenomena Genetic Phenomena [G05] Immune system processes [G12] Mathematical Concepts [G17] Metabolic Phenomena [G03] Microbiological Phenomena [G06] Ocular Physiological Phenomena [G14] Physical Phenomena [G01] Physiological processes [G07] Reproductive physiologi cal processes [G08] Bacterial Infections and Mycoses [C01] Blood and lymphatic diseases [C15] Cancer [C04] Cardiovascular Diseases [C14] Congenital, Hereditary, and Neonatal Diseases and Digestive System Diseases [C06] Ear, nose and throat diseases [C09] Eye Diseases [C11] Female diseases of the urinary and reproductive Hormonal diseases [C19] Immune System Diseases [C20] Injuries, poisonings, and occupational diseases [C21] Male diseases of the urinary and reproductive Mouth and tooth diseases [C07] Musculoskeletal Diseases [C05] Nervous System Diseases [C10] Nutritional and Metabolic Diseases [C18] Parasitic Diseases [C03] Respiratory Tract Diseases [C08] Skin and Connective Tissue Diseases [C17] Symptoms and general pathology [C23] Virus Diseases [C02] Environment and Public Health [N06] Health Care Economics and Organizations [N03] Health Care Facilities, Manpower, and Services [N02] Health Care Quality, Access, and Evaluation [N05] Health Services Administration [N04] Not Specified Behavioral Disciplines and Activities [F04] Behaviours [F01] Mental Disorders [F03] Psychological processes [F02] (leeg) BE EU total 4

5 Ratio of approved trials ( ) per therapeutic area, BE vs. EU and per capita Ratio approved trials, taking into account that Be represents 2.2 % of the EU population (red line) 50,0 45,0 40,0 35,0 30,0 25,0 20,0 15,0 10,0 5,0 0,0 Trials above the red line are better than the EU average 5

6 Belgium vs. Europe Amount of vaccine CT: Belgium vs. Europe % Amount % 15% 10% 5% Relative % Belgium vs. Europe Belgium Total EU (vaccine) %Be (/Total EU vaccine) Year 0% 6

7 EU landscape 25% Total EU (vaccine) 20% Relative amount to EU 15% 10% 5% 0% Absolute EU amount %UK (/Total EU vaccine) %Belgium (/Total EU vaccine) %Germany (/Total EU vaccine) %Netherlands (/Total EU vaccine) %France (/Total EU vaccine) Year 7

8 Profile of trials and populations Absolute Relative Belgium 88 NA Therapeutic 16 18% Prophylactic 53 60% EU 670 NA Therapeutic % Prophylactic % Age profile Amount In utero 1 Preterm born 0 Newborns 2 Infants 5 Children 5 Adolescents 5 Adults 76 Elderly 36 Individual profile Amount Male 76 Female 86 Pregnant 3 8

9 Commercial vs. noncommercial 100% Relative % of Commercial & Noncommercial 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% UK Belgium Germany Netherlands France EU non commercial commercial Country 9

3. Focus on early access to innovation: scientific advice 3 main pillars of future activities Scientific & technical/regulatory advice: optimising current services + staggered scope expansion to

10 3. Focus on early access to innovation: scientific advice 3 main pillars of future activities Scientific & technical/regulatory advice: optimising current services + staggered scope expansion to borderline & DDCPs, IVDs (CoDx), medical devices & Blood, cells & tissues implementing new services (eg. iterative, fast-track advice) Specific support to SMEs, start-ups and academic research centers/hospitals General innovation support & knowledge management EU-IN activities open to all innovators involved in R&D integrated life-cycle approach 10

11 3. Focus on early access to innovation: national scientific advice Spearheads Oncology 14,29% Vaccines 27,27% Early phase development 54,55% 0% 10% 20% 30% 40% 50% 60% 11

12 3. Focus on early access to innovation: national scientific advice (applications validated ) 12

13 3. Focus on early access to innovation: scientific advice at SAWP : 45 SAWP advices provided by the BE team (30%) 13

14 3. Focus on early access to innovation: PRIME The FAMHP in the top 5 14

15 4. Marketing authorisation: BE rapporteurships CHMP PRAC Hexavalent pediatric vaccine Pneumococcal vaccine Rotavirus vaccine Human papilloma virus vaccine Influenza vaccines Hepatitis B vaccine Meningococcal ACWY (RMS) Measles Mumps Rubella vaccine (co-rapp) Hexavalent pediatric vaccine Hepatitis B vaccine Malaria vaccine Meningococcal group B vaccine Rotavirus vaccine HPV vaccine Flu vaccine Pneumoccocal vaccine (co-rapp) Measles Mumps Rubella vaccine (co-rapp) : 17 applications for vaccines via the centralised procedure EMA: CHMP: 7 rapporteurships, 3 co-rapporteurships, 5 peer reviews PRAC: 7 rapporteurships, 2 co-rapporteurships 15

16 5. Spearhead Early Phase Development Regulatory and scientific advice concerning early phase trials Clinical Trial attractiveness: network of well known phase I centers, recruiting healthy volunteers Stable number of phase I and FIH clinical trials Phase I centers all inspected for GCP and if producing IMP s also for GMP 16

17 5. Spearhead Early Phase Development Accreditation of Phase I centers on voluntary basis Also recognised clinical centers recruiting patients into early phase clinical trials Exploratory clinical trials Participation at national and EU level in advices, drafting and training (SAWP, drafting group FIH GL at EMA, the ANSM CSST Rennes, EU NTC) 17

18 5. Spearhead Vaccines A Belgian network of four core expert activities, each embedded within an national and international network GMP-GCP- Pharmacovigilance inspections (including third countries) Batch release: Close collaboration with Belgian OMLC Active vaccine-vigilance projet Postlicencing surveillance Scientific - regulatory advice A point of reference at national and EU level Advice on quality nonclinical-clinical aspects Network of in-house and external experts (universities and research centers, government institutions: PHI- INAMI) Leading role at EMA, the CHMP and PRAC for rapporteurship, including first PRIME vaccine Internal regulatory network : presence in national and international committees (EMA Vaccine Working Party, FDA, WHO SAGE, CEPI) Marketing authorisation Clinical trials Network of well known vaccine clinical trial centers, including phase I and challenge trial unit. Ongoing research project to keep Belgium s attractiveness 18

19 5. Spearhead Vaccines Point of reference for regulatory and scientific advice at European and national level Clinical Trial attractiveness: network of well known vaccine clinical trial centers, including human challenge unit Leading role at EMA CHMP and PRAC for rapporteurship of new marketing authorisation (including first PRIME vaccine evaluation) Point of reference for GxP inspections (including third countries inspection) Representation in national and internal committees and working groups (EMA Vaccines working party, FDA, WHO Sage, CEPI ) Scientific and regulatory expertise: network of internal and external expertise (universities and research centers, government institutions) 19

20 6. Conclusions - Solid EU regulatory network HMA-EMA is key. - The FAMHP is fully engaged in this structure and philosophy. - The FAMHP fully subscribes the necessity to strongly interact with universities and research centers and the pharmaceutical industry (national and global). - The FAMHP recognises the strengths of the different agencies (i.e. spearheads and multinational teams). - The FAMHP will consolidate the impact of the Brexit (additional workload/opportunities). 20

21 Contact Federal Agency for Medicines and Health Products FAMHP Place Victor Horta 40/ BRUXELLES tel fax welcome@fagg-afmps.be 21

22 Your medicines and health products, our concern

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