1 No of Selected Activities in the EU 2007 EU new applications - PDF document

Estonia How can non-contributing agencies Population: 1,34 mill be encouraged to participate (65% Estonians) Kristin Raudsepp, MD Director General, Estonian State Agency of Medicines HMA Management Group HMA Resource Planning Working Group The presentation Some useful links • What do we mean with “contributing agency” • http://www.hma.eu • What do we mean with “co-operative company” • Why do they do it • What can be done to encourage wider participation? • Situation with different procedures • Update of the medicinal products market in Estonia. EU procedures needing resources from MS What is new agency • (co)rapporteurs for concept papers/guidelines/documents for CHMP WP-s • (co)rapporteurs for dossier evaluation referred to the WP • 1957: 6 countries in EU • (co) rapporteurs for scientific advice referred to the WP by the CHMP Scientific Advice WP • 1973: 3 new countries in EU • CMDh - Mutual recognition new applications • 1981: 1 new country in EU • CMDh - Decentralised new applications • CMDv - Mutual recognition new applications • 1986: 2 new countries in EU • CMDv - Decentralised new applications • 1995: 3 new countries in EU • (co)rapporteurs at the CHMP • 2004: 10 new countries in EU • CHMP peer review appointments • (co)rapporteurs (incl MRL) at the CVMP • 2007: 2 new countries in EU • coordinators for PMF Certification • 20..... • monographs for HMPC • COMP • EC working groups 1

No of Selected Activities in the EU 2007 EU new applications network in 2006 • New applications MRP started - 396 HMPC, No of monographs, active in 2006 (*the numbers may differ because of the variety of sources) CVMP, No of (co)rapporteurships (incl MRL), active in Dec 2006 CMDv - Decentralised new applications finalised in 2006 • New applications DCP started - 1033 CMDv - Mutual recognition new applications finalised in 2006 200 CMDh - Decentralised new applications finalised in 2006 CMDh - Mutual recognition new applications finalised in 2006 • The total number of new applications for 150 CHMP, No of (co) rapporteurs for scientific advice referred to the WP by the CHMP SA WP CHMP, No of (co)rapporteurs for dossier evaluation referred to the WP, active in 2006 initial evaluation in CHMP - 90 CHMP, No of (co)rapporteurs for concept papers/guidelines in WP-s, active in 2006 100 CHMP, No of peer review appointments in 2006 CHMP, No of (co)rapporteurships, new appointments in 2006 50 0 DE NL UK SE DK FI FR E S IE IT BE PT NO HU CZ E E SI AT LU PL LT IC MT SK GR LV CY LI No of employees in CA of EEA + EMEA Contributing agencies human+vet, and in some countries cosmetics, devices, reimb, pestic HMA 2008 1200 • Agencies with resources and motivation 1000 • Agencies with no resources, but with motivation 800 • (Agencies with resources, but with no 600 motivation) 400 200 • Estimated MRP/DCP procedures in MS 0 1 1 1 2 K E S 1 E T L 1 T E L O L U I 2 G V 2 T I 2 E E 2 S 2 1 2 U A E R K E O F K O S E R K T T D S E B P P Z A I E N N H B L L Z D I I M Y Y L E range from 2 to 400 per year. D F U D R C U R C F S C C M E Possible view of a MS about motivation • Acting as a RMS or (co)rapporteur does not often mean the product will be put on the market of the MS after the granting of marketing authorisation. • Being active and working diligently in the European market processes, does not help State Agency of Medicines small countries to get products on their own. ESTONIA; e-mail: info@ravimiamet.ee; homepage: www.ravimiamet.ee 2

What is our situation in Estonia What have we done to cope • Priority list of targets and actions • The budget of SAM in 2008 is 2,5 million Euros • Risk analyses which is 40 times less than budget of biggest • Learning from the more experienced CAs in EU agencies • We have 80 people (covering MA, drug • Quality system information, adverse reactions, inspections, lab, clinical trials, veterinary medicines, medical • Benchmarking devices, biological products) • Perfomance indicators • Following the plan, but being flexible The Estonian Medicinal Products Market Patients’ needs in small countries (billion EEK, wholesale data) 3 2,67 +17,9% 2,5 +12,4% +4,8% 2,26 2,01 2 +20,4% 1,92 1,6 1,47 1,5 1,3 1,13 1 0,89 0,5 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 144,5 171 million million EUR EUR Patients’ needs in small countries Patients’ needs in small countries • The same as in bigger and • The same as in bigger and richer ones richer ones –i.e. Access to the medicines which efficacy, quality and safety has been proven and maintained through its cycle 3

Estonia as a RMS The side effects of being small (applications received) • Big opportunity to work as a fireman • 2005 – 3 MRP • The risks are high, as one individual is • 2006 – 1 DCP responsible for too big part of your work • 2007 – 11 DCP + 2 MRP + 1 RU MRP • The limited number of good people • 2008 6k – 30 DCP • The same limited number of good people • First MRP ended 30.06.2005 is attractive for the companies ketoconazole Initial applications per type in Estonia MA applications in Estonia Initial applications 2004-2008 6 month 9000 700 8000 600 7000 17 31 15 6000 9 500 Line extension Variations 5000 Hybrid 16 7105 7323 8 Renewal 400 Fixed combination 4000 5756 Initial 14 0 Generic 5 3000 3984 28 300 448 476 3 4 Bibliographic 2974 280 2000 2301 Informed concent 1985 1000 200 195 Full dossier 319 456 396 279 186 355 458 574 180 376 363 325 448 548 335 0 56 100 20 17 2002 2003 2004 2005 2006 2007 2008- 24 31 75 71 1 53 34 18 6k 9 0 0 2004 2005 2006 2007 2008 6 month Started procedures in EU Dilemmas of the agency • Do we trust each other enough to rely totally on RMS for MA Applications (MRP/DCP) in 2008 mutual recognition 40 • How many centr assessments or RMS is enough 35 • Workload has increased considerably because 30 of the broad range of topics (regulatory, 25 procedural and scientific) 20 • Interest for fees 15 10 • The agency does not have legal way to refuse 5 from EU work 0 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 • The agency does not have legal pressure about how much EU work should be done Source: Feb07 to Jan08 CMD(h) Press Releases 4