Transcript Document

EU Databases and New Initiatives
(EudraCT & 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 Telematics Strategy
• IT systems to help implementation of
pharmaceutical legislation requirements
• Improve networking in the community
Marketing Authorisation system
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Paperless operation
Reduction in duplicate solutions
Improved information flow
Improve access to information
• Within the regulatory network
• To the general public
EU Databases - EudraCT
EudraCT 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
• EudraCT database contains:
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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 - EudraCT
EudraCT database
• Will be updated in phases
• Lot 2A
– Version 3.0.0.: Was due 18 November 2005. Technical problems at EMEA. Not
yet in place.
– Version 4.0.0.: Due Q2 2006
• Lot 2B: 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 MedDRA code, classification
– CA view and compare historical version of CTA forms
EU Databases - EudraCT
EudraCT database
• Changes in Version 3.0.0. - Section D
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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 EudraCT home page including
FAQs and list of key changes to CTA form
EU Databases - EudraCT
EudraCT database Lot 2A
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Based on stakeholders priorities
Enhancing EudraCT performance
Improving data coding
Improving utilities for Member States CAs
Providing added utilities for sponsors
EU Databases - EudraVigilance
EudraVigilance
• 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
– EudraVigilance Post Authorisation Module (EV PM)
Regulation 726/2004/EC, Directive 2001/83/EC and Vol.9 “Rules Governing MP in EU”
– EudraVigilance Clinical Trial Module (EV CTM) for pre-authorisation
SUSARs – Directive 2001/20/EC
EU Databases - EudraVigilance
EudraVigilance - 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 EudraVigilance
– For MAH, SUSAR from non EEA country for a product not approved in any EEAMS 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 - EuroPharm
EuroPharm 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 – EudraGMP
EudraGMP
• 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 – EudraNet
EudraNet
• 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
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 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
• 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 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 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:
• 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 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
Thank you very much for your
attention
Dr. Martine Dehlinger-Kremer
Vice President International Regulatory Affairs
+49 6196-5228-350
[email protected]