Clinical Trials in Portugal. Wellcome!

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1 CMC Strategy Forum Europe 2009 Clinical Trials in Portugal. Wellcome! R&D Coordination PT delegate at BWP/CHMP, CPWP/CHMP and alternate member of CAT - EMEA (margarida.menezes@infarmed.pt)

2 Clinical Trials in Portugal Inicial PT regulation of CT PT adoption of EU CT Regulation Legal: DL n.º 97/95, May 10 hospital ethical committees Systematic Data collection national database transition Legal series: National ethical committee - CEIC DL 97/94, April 9 Lei 46/04, Aug 19 Progressive regulation harmonization EU CE GCP Directive 2001/20/EC (Transposed in Lei 46/04, Aug 19 ) IMP GMP Directive 2003/94/EC (Transposed in DL n.º 176/06, Aug 30 ) GCP & GMP Directive n.º 2005/28/EC) (Transp. in DL 102/07, Abr 2) Increase subjects protection / scientific credibility of the results

3 CT S S ASSESSMENT CEIC Ethical Committee Subjects Protection Information and Consent, Recrutment procedures Compensation / liability INFARMED, I.P. Competent Authority IMP Quality and Safety Pharmaceutical quality data Preclinical / toxicological data Clinical data / previous human exposure Trial Scientific relevance Benefit / risk Assessment Protocol Objectives and means Investigators Qualification Safety of subjects Trial information Protocol (population, intervention, time of exposure, etc) Human and structural resources / research hospital facilities

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5 Consulted in April 20, 2009 EU MS nº trials population trials/100,000 DK BE AU FI SE ND FR IR UK DE LUX PT IT

6 Consulted in April 20, 2009

7 Consulted in April 20, 2009 PHASE I PT = 7 3 cancer 2 ophthalmology 2 neurology

8 CLINICAL TRIALS INFARMED 2009 T1 APPLICATION TYPE Clinical trial (legal <60 days) variation (<35 days) Total Applications completed estimate performed Applications completed on time conclusion days (mean) estimate performed estimate performed

9 CLINICAL TRIALS INFARMED 2009 T1 COD ATC 2008 T1 ANO 2009 T T T T4 L N J B C S A R H M G D V Antineoplasic and Imunomodulators Central Nerve System Anti-Infeccious diseases Blood e Haematopoiesis Cardiovascular System Sensory Organs Gastro, intestinal metabolic Respiratory System Endocrine System 0 Skeletal Muscle Genito. Urinary. Sexual Dermathologics 0 Outros

10 IMP Type in CT: Portugal vs EU Portugal RadioFarm UE Terapia Génica OGMs Terapia Celular Herbal RadioFarm Homeopáticos 2% Origem Biológica 44% 56% Químicos Origem Biológica 42% 56% Químicos Bio.OGMs; Bio.D.-Plasma; Terapia Celular; Terapia Génica; OGMs; MBPantas Homeopáticos = 0 (fonte: EudraCT)

11 Phase and Sponsorship Type: : PT vs EU Trial Phase And Sponsor type 100% 90% EU 12% PT 13% UE 20% Académicos Academy 80% 70% 60% 50% 40% 30% 40% 27% 65% IV III II I Pharma Comerciais Industry PT 80% Academy Académicos 5% 20% 10% 21% 19% 95% 0% Fist in man, 4% 4% Comerciais Pharma (fonte: EudraCT) Industry

12 One Clinical trial on its way through the approval procedure in the EU Time Competent Authorities Ethics Committees Results From comunication of Dr. Hartmut Kraft, "the Importance of clinical trials shared assessment" in Conference "Intervention Strategy of Health Product Agencies: Streghtening of Cooperation and Information on Work Sharing" 12 December 2008, Paris -

13 Voluntary Harmonisation Procedure (VHP) Supported by Heads of Medicines Agencies Volunteer sponsor volunteer NCAs Pilot phase to start in Feb Pre submission to CTFG and common assessment by participating NCAs, then the national step (formal CTA to NCA) Tools : Common objectives : subjects safety ; IMP quality safety; best time frames, A common CTA core data set, a single repository, an electronic submission, From comunication of Dr. Hartmut Kraft, "the Importance of clinical trials shared assessment" in Conference "Intervention Strategy of Health Product Agencies: Streghtening of Cooperation and Information on Work Sharing" 12 December 2008, Paris

14 Criteria for application/selection for VHP pilot phase -only MN-CTswithout MA in the EU with the following criteria would undergo the VHP: FIH MN-CTs and particularly with investigational medicinal products with known or anticipated risk factors as described in EMEA/CHMP/SWP/294648/2007. MN-CTs with Critical investigational medicinal products (limited community expertise e.g. IMP with novel modes of action, novel manufacturing process, novel administration and storage requirements, links to a class of medicinal product with recognised safety concerns, unresolved pre-clinical abnormal findings, for instance monoclonal antibodies, advanced therapies) or Critical MN-CTs (e.g. for limited trial populations e.g. orphan diseases, less common types of cancer, paediatrics diseases with small numbers, adult diseases with small numbers or unmet medical needs), based on NCA s judgement, endorsed by the CTFG MN-CTs with very large population and where the sponsor indicates a need for harmonisation (e.g. large phase III CTs and many MS concerned) CTA decisions in VHP- Phase III remain on a national level. From comunication of Dr. Hartmut Kraft, "the Importance of clinical trials shared assessment" in Conference "Intervention Strategy of Health Product Agencies: Streghtening of Cooperation and Information on Work Sharing" 12 December 2008, Paris

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