FACTS Federal Office for Safety in Health Care 1
BASG / AGES MEA Federal Office for Safety in Health Care (BASG) and Austrian Medicines and Medical Devices Agency (AGES MEA) The Federal Office for Safety in Health Care (BASG) and the Austrian Medicines and Medical Devices Agency (AGES MEA) were both set up in January 2006. The BASG is directly subordinated to the Austrian Federal Ministry of Health and Women (BMGF), carrying out sovereign tasks, including authorisation and control of medicinal products and vigilance of devices. BASG consists of three members appointed by the Federal Minister of Health, one member from BMG and from AGES MEA each. The third member is the head of the AGES MEA. AGES MEA is therefore closely linked to the BASG, constituting two of its members, providing BASG with necessary resources, staff and infrastructure. When carrying out sovereign activities, the employees of AGES MEA are acting on behalf of BASG. Responsibilities of AGES MEA include providing Scientific Advice, inspecting according to GMP, GLP and GCP, assessing dossiers for new marketing authorisations of medicinal products, as well as European surveillance of medicinal products and medical devices already marketed, in terms of efficacy and possible side effects, i.e. pharmacovigilance, and all processes related to Lifecycle-Management. AGES MEA is also monitoring blood-and tissue-vigilance issues. SCIENTIFIC ADVICE Scientific advice for applicants When developing medicines, pharmaceutical companies have the possibility of obtaining scientific advice from AGES MEA. Both types of procedures (EMA Scientific Advice/National Scientific Advice) represent specified focus areas. In the case of enquiries from the field of new substances (chemical and bio), but also from the development of biosimilars and generics, AGES MEA ranks consistantly amongst the leading medicines agencies within the EU. With regard to the number of scientific advice procedures it occupied the 1st placetop-position among all EU agencies. This achievement illustrates impressively the extensive know-how available for applicants and customers of AGES MEA to benefit from. VALUES OF AGES MEA WE ARE RESPONSIBLE WE ARE OBJECTIVE WE ARE COMPETENT WE ARE EUROPEAN Number of EMA Scientific Advice Procedures 104 119 2015 2014 Processes of the Austrian Medicines and Medical Devices Agency in the Life-Cycle of Medicinal Products Adaptive Pathways Suspension of Marketing Scientific / Regulatory Advice Variations/ Renewals of Marketing Variations of Manufacturing Manufacturing (GMP- Inspections) Safety Signals & Risk Management periodic GMP-Inspections PV-Inspections Market Surveillance Authority Batch Release Assessment of Clinical Trials GLP- & GCP- Inspections Marketing SAWP - Scientific Advice in 2015 Procedures 12% 11% 11% 41 109 29 107 105 80% 9% 9% 9% 86 86 83 AT Coordinator AT Peer Review 7% 65 6% 6% 57 54 4% 4% 4% 42 41 39 3% 3% 31 29 1% 9 AT 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Member States 2 3
CLINICAL TRIALS MARKETING AUTHORISATION of clinical trials Approval procedure - Main areas of focus Core competences of AGES MEA 2016 2015 2014 2013 2012 2011 2010 36 83 113 27 259 39 70 151 45 305 23 71 115 39 248 31 87 145 55 318 33 85 139 43 292 41 107 150 46 327 46 99 158 46 336 Phases of submitted clinical trials Phase I Phase II Phase III Phase IV AGES MEA conducts a scientific assessment of the chemical, pre-clinical and clinical data of the application for marketing authorisation. This assessment determines the outcome of the decision regarding the approval of a medicine. In recent years emphasis has been placed on these features both with regard to the approval of generics (more than 90 % of all national authorisation applications), as well as in the field of biotechnology. Blood- and plasma products, vaccines, monoclonal antibodies (MAbs), biosimilars and the field of immunology are all core competencies of the AGES MEA. BLOOD- AND PLASMA PRODUCTS VACCINES BIOSIMILAR PRODUCTS Commercial Trials in AT Academic Trials in AT 150 40 30 Phase I Phase II 20 Phase I Phase II 50 Phase III Phase IV 10 Phase III Phase IV Numbers 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Numbers 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Year Year 4 5
AUTHORISATION AND LIFECYCLE- MANAGEMENT OF MEDICINAL PRODUCTS MRP/DCP Procedure AGES MEA plays a sustained and leading role as Rapporteur in the centralised procedure (CP) and as Reference Member State (RMS) in the evaluation of mutual recognition and de-centralised authorisation procedures (MRP/ DCP). For years now, Austria has been in the EU Top 10 in MRP/DCP procedures. Since 2009 Austria has constantly occupied a top ten place in the overall European comparison. Recently Austria also entered Top ten in centralised procedures. This achievement clearly underlines the obvious commitment on the part of the Austrian medical authority to be at the forefront of helping to shape matters at a European level - both in the interest of applicants and of public health. Centralised Procedure 39 40 Top ten place in European comparison since 2009 293 273 173 133 131 89 38 36 34 22 19 15 13 10 10 8 8 7 7 6 6 5 5 3 0 0 0 0 0 NL DE UK DK PT SE HU AT ES CZ FI FR NO IS MT IE PL SI SK BE IT EE LV HR LT BG CY EL LU 21 78 36 32 64 68 MRP 50 50 DCP 65 59 35 41 2010 2011 2012 2013 2014 2015 300 200 59% early finalised, 41% timely finalised Overview on finalised human MR- and DC-procedures per RMS 2016 Fast processing, time kept as short as possible, many DCP procedures can be finalised before day 210 33 timely finalised early finalised ) 25 21 16 14 11 10 9 8 7 7 7 7 7 7 6 6 5 3 3 2 2 30 20 10 0 0 0 0 0 0 0 Austria in comparison to other agencies per number of Rapporteur and Co-rapporteurships in the centralised procedure 542 477 329 196 1.260 1.196 1.077 989 1.002 941 850 748 693 646 667 595 1.000 691 465 482 533 606 435 471 375 281 213 228 271 227 164 194 193 134 124 60 85 2004 2004 2005 2005 2006 2006 2007 2007 2008 2008 2009 2009 2010 20102011201120122012 2013 20132014201420152015 Marketing authorisations issued over the last years national vs MRP/DCP MS 1 MS 2 MS 3 MS 4 MS 5 Austria MS 7 MS 8 MS 9 MS 10 MS 11 MS 12 MS 13 MS 14 MS 15 MS 16 MS 17 MS 18 MS 19 MS 20 MS 21 MS 22 MS 23 MS 24 MS 25 MS 26 MS 27 MS 28 MS 29 MS 30 Proced. nat. nat. Proced. MRP&DCP Sum of of procedures finalised 6 7
s and Variations OMCL 1.750 1.500 1.250 1.000 750 500 250 1.196 15.416 26.885 1.260 25.793 941 27.031 595 28.949 435 30.751 691 35.000 30.000 25.000 20.000 15.000 10.000 5.000 30.751 Variations 691 New Market s Batch release 2.000 1.961 1.613 1.512 2.068 1.980 2.292 2.473 2.683 3.005 3.368 Approval of plasma pools 2006-2015 0 2010 2011 2012 2013 2014 2015 0 New Marketing s Variations (single applications) New Marketing s vs. Variations 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 SURVEILLANCE Market surveillance Inspections Market surveillance: sample structure 2015 Numbers of domestic and foreign countries inspections 166 196 175 Samples from: legal market 92 227 33 illegal market 169 300 300 90 272 231 240 214 200 200 174 pharmacopoe development 21 QMM (reports of quality defects) Routine quality control national Routine quality control international 59 49 55 53 2011 2012 2013 2014 2015 domestic inspections foreign inspections 73 88 126 88 2007 2008 2009 2010 2011 2012 2013 2014 2015 TBE Others Total number of human vaccines 109 146 Influenza Meningococcal group C vaccines Veterinary vaccines Batch Release of vaccines 2007-2015 8 9
CONTACT BASG & AGES MEA BASG - Federal Office for Safety in Health Care AGES MEA - Austrian Medicines and Medical Devices Agency Traisengasse 5, 1200 Vienna Head of AGES MEA, Procedural Member BASG Dipl.-Ing. Dr. Christa Wirthumer-Hoche basg_anfragen@ages.at +43 (0) 50 555-36111 10 11
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