Ensuring protection of public health and patients in member states: priorities, constraints, opportunities Dr. Christa Wirthumer-Hoche AGES Austrian Medicines and Medical Devices Agency Vienna, Austria April 15, 2014 Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
AGES - Our Vision Health for Humans, Animals and Plants 2
AGES Structure 1) 2) Division Food Security Food Safety Veterinary Medicine Public Health Austrian Medicine & Medical Devices Agency Radiation Protection Department Data, Statistics & Integrative Risk Assessment Knowledge Transfer & Applied Research 1) Austrian Federal Office for Food Safety 2) Austrian Federal Office for Safety in Healthcare 3
Austrian Medicines & Medical Devices Agency New structure of the Austrian Agency since 1st Dec 2013 - Reorganisation 3 Instituts oreshaping for the future Life Cycle Management MRP/DCP/pure national Analytical and assessment focus on CP & PHV Inspection & Medical Devices - Strengthen communication 4
Austrian Medicines and Medical Devices Agency Vision We strive, within our areas of responsibility, to take a leading role among medicines agencies in Europe Mission We are the national competent authority for medicinal products and medical devices and a partner to competent authorities and agencies throughout Europe. 5
Processes of the AGES MEA in the Life-Cycle of Medicinal Products! therapeutic concept Scientific / Regulatory Advice Manufacturing Authorisation (GMP-Inspections) Assessment of Clinical Trials GLP- & GCP-Inspections Marketing Authorisation Suspension of Marketing Authorisation Variations / Renewals of Marketing Authorisation Variations of Manufacturing Authorisation Safety Signals & Risk Management periodic GMP-Inspections Market Surveillance Official Control Authority Batch Release 6
Scientific Advice AT No 3 in EU ranking ~ 20% of all procedures each year Source: EMA 7
Priorities for the Austrian Medicines Agency We ensure high-quality, safe and effective medicines for patients Availability/Supply of essential medicines Rapid market access for new/innovative medicinal products Pro-active information for patients and healthcare personal Good cooperation with NCAs, EMA, EDQM, Ministry, 8
European Network SK BE UK LT LU LV EMA MT NL GR PL CY PT AT CZ DE EC EE IT DK ES BG FR SI HU FI SE HR IE IT EDQM Christa Wirthumer-Hoche 9
European System We are not working in isolation - We are working within a Network!! Unique system 28 MS + 3 EEA (~ 44 national agencies) EMA EDQM EC Christa Wirthumer-Hoche 10
Authorisation system Licensing of medicinal products is stronlgy regulated Almost all legislation and requirements are based on harmonised EU rules Global harmonisation has advanced dramatically Christa Wirthumer-Hoche 11
EU Network Centralised activities Multinational non-centralised activities National activites The same resources at NCAs underpin all three! Worksharing is essential Christa Wirthumer-Hoche 12
Opportunities We as NCAs have to work together efficiently and use the same language and standards We as NCA cooperate and contribute in further various worksharing projects, e.g. MRP/DCP role of RMS (#7 in EU ranking) CP role of Rapporteur/Co-Rapporteur (#9 in EU ranking) EMA scientific advices (#3 in EU ranking) 13
Participation of AT as Rapporteur/ Co-Rapporteur in CP (source EMA) 14
MRP/DCP New applications 2006-2013 FINALISED Procedures DCP 1600 1452 1381 1400 1304 1198 1200 1052 1000 800 734 600 386 400 200 57 0 2006 2007 2008 2009 2010 2011 2012 2013
New applications 1 Jan 31 Dec 2013 16
Why do we need worksharing? Duplicated assessment Divergent decisions Increased requirements Reduced human resources Increased workload (all parties) 17
An example for Worksharing Quality documentation for the Active Substance for a Medicinal Product Assessment team: Different locations, but mostly same assessors from NCAs Licensing authority ASMF EDQM CEP o ASMF-Worksharing: AT is Rapporteur of European ASMF number 00001, ASMF Worksharing project helps to save ressources on all sides (NCAs, EDQM and industry) and ensures harmonized and rapid assessment o AT- one of the most active EU-MS in the certification procedure
Opportunities We as NCAs have to work together efficiently and use the same language and standards We accept and promote use of CEPs CEP procedure helps to update Ph.Eur. monographs as a result of assessment We cooperate to constantly enhance quality of Ph. Eur. by participating in elaborating monographs 19
Contribution of AT to EDQM work CEP assessment 11 chemical assessors participated in CEP sessions corresponding to 84 assessment days 2 biological assessors participated in CEP sessions corresponding to 2 assessment days 1 chemical assessor is member of the chemical Technical Advisory Board (TAB - deals with technical or scientific questions raised by the assessors and prepares/discusses technical guidance documents) 1 chemical assessor is member of ad Hoc Committee (is involved in decision process regarding suspension/withdrawal/ restoration of CEPs) 20
Constraints Inspections, Q-defects Focus inspection ressources (worldwide), enhance global mutual recognition Increasing number of GMP inspections with negative outcome non-compliance reports (NCRs), suspensions/withdrawals of CEPs Shortages of essential medicinal products Falsification 21
Shortages of medicinal products The number of serious shortages in the EU is increasing Reason: - Manufacturing problems - Poor product quality (eg. impurities) - Lack of production capacity Problem: - National Competent Authorities may not have received all relevant information on time - When no proper alternative treatment is available in short term.
Quality of medicinal products Has to meet international standards of quality (eg. - Ph.Eur.) and to fulfill requirements Only products of good quality ensure proven safety and efficacy High quality ensures protection of public health and patients 23
Thank you for your kind attention! Questions? 24