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EU Databases and New Initiatives (Eudra. CT & Pharmacovigilance databases, Paediatric Initiative) Conference B&Cemo, EU Databases and New Initiatives (Eudra. CT & Pharmacovigilance databases, Paediatric Initiative) Conference B&Cemo, Paris 25 January 2006 Dr. Martine Dehlinger-Kremer, VP Regulatory Affairs Int'l Omnicare Clinical Research

EU Databases EU Databases

EU Databases EU Telematics Strategy • IT systems to help implementation of pharmaceutical legislation EU Databases EU Telematics Strategy • IT systems to help implementation of pharmaceutical legislation requirements • Improve networking in the community Marketing Authorisation system – – Paperless operation Reduction in duplicate solutions Improved information flow Improve access to information • Within the regulatory network • To the general public

EU Databases - Eudra. CT database • Established based on Art. 11 of EU EU Databases - Eudra. CT database • Established based on Art. 11 of EU Clinical Trials Directive 2001/20/EC • Released 01 May 2004 • Accessible only to Competent Authorities of Member States, the Agency and the Commission • Eudra. CT database contains: – – – Extracts from the request for authorisation Any amendments made to the request or to the protocol Opinion of the Ethics Committee Declaration of the end of Clinical Trial Reference to inspections • Further extension is planned

EU Databases - Eudra. CT database • Will be updated in phases • Lot EU Databases - Eudra. CT database • Will be updated in phases • Lot 2 A – Version 3. 0. 0. : Was due 18 November 2005. Technical problems at EMEA. Not yet in place. – Version 4. 0. 0. : Due Q 2 2006 • Lot 2 B: Due by 2007. Changes not yet identified • Changes in Version 3. 0. 0. – Alert to concerned CAs at trial refusal or non-approval – Alert to all CAs at interruptions, premature end, temporary halt for reasons of safety, lack of efficacy and suspensions – Search medical products dictionary for authorised active substances – Look-up and populate one Med. DRA code, classification – CA view and compare historical version of CTA forms

EU Databases - Eudra. CT database • Changes in Version 3. 0. 0. - EU Databases - Eudra. CT database • Changes in Version 3. 0. 0. - Section D – – – Organisation of information about marketed IMPs MS where IMP has previously been used in trials Information about Scientific Advice (SA to be declared) Presentation of information on duration and dose Extended list of IMP type (EU Commission drafting a paper to address issue of which products are to be considered as IMP (add on, rescue, challenge agents) ) – Site releasing IMP listed by IMP • Changes in Version 3. 0. 0. – Information on EMEA website and Eudra. CT home page including FAQs and list of key changes to CTA form

EU Databases - Eudra. CT database Lot 2 A • • • Based on EU Databases - Eudra. CT database Lot 2 A • • • Based on stakeholders priorities Enhancing Eudra. CT performance Improving data coding Improving utilities for Member States CAs Providing added utilities for sponsors

EU Databases - Eudra. Vigilance • Safety database for all products marketed in the EU Databases - Eudra. Vigilance • Safety database for all products marketed in the EU and for those under investigation • Full Compliance with ICH specifications • System includes a fully automated safety and message processing mechanism using XML-based messaging and a large reference pharmacovigilance database incorporating an extensive query and tracking/tracing capability • Composed by – Eudra. Vigilance Post Authorisation Module (EV PM) Regulation 726/2004/EC, Directive 2001/83/EC and Vol. 9 “Rules Governing MP in EU” – Eudra. Vigilance Clinical Trial Module (EV CTM) for preauthorisation SUSARs – Directive 2001/20/EC

EU Databases - Eudra. Vigilance - Reporting Rules • Sponsors who are MAH for EU Databases - Eudra. Vigilance - Reporting Rules • Sponsors who are MAH for at least one of IMPs used in protocol report either to EV CTM or EU PM • Sponsors who are not MAH of any of IMPs used in protocol address all reports to the EV CTM • To all sponsors – SUSARs occurring in any interventional trial are sent to EV CTM (including comparator, i. e. , active control or placebo) – To avoid double reporting, SUSARs submitted to CMS will not be forwarded by the CMS to Eudra. Vigilance – For MAH, SUSAR from non EEA country for a product not approved in any EEA-MS and that qualify as spontaneous reporting country of origin will be reported to EU PM (spontaneous reports always in EV PM) – For MAH, SUSAR from organised data collection other than interventional trials for IMP registered in at least one EEA-MS will be submitted to EU PM

EU Databases - Euro. Pharm Database • For authorised medicinal products (Regulation 726/2004) • EU Databases - Euro. Pharm Database • For authorised medicinal products (Regulation 726/2004) • First production version in 2005 initiating a series of ten releases that will culminate in the fully featured version being available • Will include the information contained in SPC, PIL and the one shown on the labelling • Database accessible to general public (information worded in an appropriate and comprehensible manner) • Valid for all products in EU • Name of database will be changed

EU Databases – Eudra. GMP • Community database of manufacturing authorisations and of certificates EU Databases – Eudra. GMP • Community database of manufacturing authorisations and of certificates of Good Manufacturing Practice (Directives 2004/27/EC & 2004/28/EC) • Will be filled by Member States • Is currently in the design phase

EU Databases – Eudra. Net • Supports the networking of the community marketing authorisation EU Databases – Eudra. Net • Supports the networking of the community marketing authorisation system • Allows efficient and safe exchange of information between competent regulatory authorities and EMEA • Has been operational for many years

New Initiative: Paediatric Initiative New Initiative: Paediatric Initiative

Paediatric Initiative • More than 50% of medicines used to treat children are used Paediatric Initiative • More than 50% of medicines used to treat children are used on an unlicensed or „off Label“ basis • Market forces are insufficient. Market is small. Studies in children are judged to be complex • Proposal on legislation on paediatric medicines from Commission (29 September 2004). First draft approved by EU Parliament on 07 September 2005 • Text to be agreed by Ministers, adopted by Council • Regulation to come into force end of 2006 or beginning of 2007

Paediatric Initiative • Paediatric Commitee: 31 Members; 25 Professionals • Paediatric Working Party compiling Paediatric Initiative • Paediatric Commitee: 31 Members; 25 Professionals • Paediatric Working Party compiling a list of needed products – Gastrointestinal tract, HIV, Pain, Rheumatology, Cardiology (Neurology and Asthma to be considered) • List of products, classes of products or conditions for which paediatric medicines are not required to be developed • European database: clinical trials in Paediatrics. All ongoing, prematurely terminated and completed paediatric studies (Community and third countries)

Paediatric Initiative For new medicinal products At the time of marketing authorisation application • Paediatric Initiative For new medicinal products At the time of marketing authorisation application • A reviewed Paediatric Investigation Plan and an approved Development Strategy • Data in children as agreed by the Paediatric Committee, or • Waiver from the requirement, or • Deferral of the timing of studies

Paediatric Initiative Paediatric Investigation Plan • Submit Paediatric Investigation Plan to Paediatric Committee as Paediatric Initiative Paediatric Investigation Plan • Submit Paediatric Investigation Plan to Paediatric Committee as early as possible, at the time of phase II clinical trials in adults. At that time the issue of waivers or deferral are considered • Studies started now should be acceptable, “old” studies not • Committee to review Plan within 60 days • No fee yet planned for the review of the Plan or for SA by Paediatric Committee

Paediatric Initiative Reward for studies conducted • Six (6) months extension of supplementary protection Paediatric Initiative Reward for studies conducted • Six (6) months extension of supplementary protection certificate (i. e. patent extension) • For orphan drugs, 2 years additional market exclusivity (10+2)

Paediatric Initiative For off-patent medicines For new off-patent medicines specifically developed for children: • Paediatric Initiative For off-patent medicines For new off-patent medicines specifically developed for children: • New type of Marketing Authorisation: Paediatric Use Marketing Authorisation (P. U. M. A): - Enabling 10 -years data protection - Use of existing brand name (brand recognition) - Amended data requirements

Paediatric Initiative Community Research Programme • Products/active substances not covered by patent or supplementary Paediatric Initiative Community Research Programme • Products/active substances not covered by patent or supplementary protection certificate • Funds for research to be provided in the Community Budget to support studies (seventh programme from DG Research) • Commission to publish within 18 months of the entry into force of Regulation, a detailed inventory of all incentives provided by the Community and Member States

Paediatric Initiative Conclusions • Better medicines for children • Innovation stimulated Paediatric Initiative Conclusions • Better medicines for children • Innovation stimulated

Thank you very much for your attention Dr. Martine Dehlinger-Kremer Vice President International Regulatory Thank you very much for your attention Dr. Martine Dehlinger-Kremer Vice President International Regulatory Affairs +49 6196 -5228 -350 Martine. Dehlinger-Kremer@Omnicare. CR. com