Transcript Registration in Europe Current situation and future outlook

Registration in Europe
Current situation and future outlook
Thomas Kürner, M.D.
Nippon Boehringer Ingelheim Co., Ltd.
Registration in Europe
• Authorities / organisation
• EMEA
European Agency for the Evaluation of Medicinal
Products
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Management Board
Committee for Proprietary Medicinal Products (CPMP)
Committee for Veterinary Medicinal Products (CVMP)
Permanent Secretariat
Registration in Europe
• Authorities / organisation
• 2 scientific Committees (CPMP & CVMP) :
– objective high level scientific advice
– proper co-ordination of work between the Agency and
National Competent Authorities
– Committee for proprietary Medicinal Products (CPMP) 2 representatives from each MS
– Committee for Orphan Medicinal Products (COMP)
Registration in Europe
COMP (Committee for
Orphan Medicinal Products ®
(1 member from each MS
3 members of patient
organisations
3 EMEA Representatives)
CPMP for human products
(2 member from each MS)
Scientific
Committees
Management Board
(2 representatives from
each MS, 2 from the
Commission and 2
appointed by the
European Parliament)
CVMP for veterinary
products
(2 members from each MS)
Executive Direction
EXPERTS
RAPPORTEURS
WORKING PARTIES
PERMANENT SECRETARIAT
Administration
validation of dossiers
EXPERTS
RAPPORTEURS
WORKING PARTIES
AGENCY
COMMISSION
Standing committee
Community decision
COUNCIL
Registration in Europe
• Marketing Authorisation Procedures
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How to market a medicinal product in the EU?
European Centralised Procedure
European Mutual Recognition Procedure
European Community Appeal, Referral / Arbitration
Post-Approval Procedures
Specific Procedures
Registration in Europe
• Marketing Authorisation Procedures
• European Centralised Procedure
– Granted by the European Commission
– Valid in the 15 Members States of the EU
– Mandatory for biotechnological products,
» developed using the recombinant DNA technology
» developed using hybridoma and monoclonal
antibody methods
– Optional for innovative medicinal products
Registration in Europe
• Marketing Authorisation Procedures
• European Mutual Recognition Procedure
– Pre-requisite = Medicinal Product not falling under the
scope of the Centralised Procedure
– National Procedure => product will only be placed on the
market of one Member State
– As soon as more than one Member State, the Mutual
Recognition Procedure must be used
Registration in Europe
• Marketing Authorisation Procedures
• European Mutual Recognition Procedure (Cont’n)
– application submitted in one MS (Reference Member State
= RMS)
– once Marketing Authorisation has been granted:
– identical applications submitted in the other Member States
(Concerned Member States = CMS)
– request to the CMS to mutually recognise the Marketing
Authorisation already granted
Registration in Europe
• Marketing Authorisation Procedures
• European Mutual Recognition Procedure (Cont’n)
– The RMS has an important role!
» At the choice of the applicant
» First marketing Authorisation in EU
» Preparation of an assessment report
» Co-ordination of the MRP between applicant and
CMSs
» Chair the Mutual Recognition Facilitation Group
(MRFG)
Registration in Europe
• Marketing Authorisation Procedures
• European Mutual Recognition Procedure (Cont’n)
– The CMS is highly involved in the MRP!
» Initiation of the MRP as soon as the 1st MA is
granted
» Recognition of the 1st MA within 90 days
» Consultation of the Assessment Report prepared by
the RMS
» Member in the MRFG
» National MA to be granted
Registration in Europe
• Marketing Authorisation Procedures
• European Centralised Procedure
• European Mutual Recognition Procedure
Comparison - Pros & Cons
Registration in Europe
• Centralised Procedure
• 1 Health Authority
• 1 Application / 1
dossier
• 1 Assessment
• 1 Marketing
Authorisation
in
15 European countries
+ Norway
+ Iceland
• Mutual Recognition Procedure
• 1 harmonised dossier
• 1 harmonised Approval decision
simultaneously up to
17 applications
17 national Authorities
17 marketing authorisations in
single countries
Registration in Europe
• Centralised Procedure
• Proposal for rapporteur
• 1 Tradename
• 1 presentation
• Negative opinion of one
MS influences EU wide
decision
• 1 MA for the EU wide
market
• procedure rather fast
• transparent process
• only one authority (EMEA)
• maintenance = 1 variation
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Mutual Recognition Procedure
free choice of the RMS
different tradenames possible
national presentation possible
possibility to withdraw a
submission in specific countries
if negative opinion
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up to 17 single MAs
sometimes delay / national level
decision process +/- transparent
up to 17 authorities
maintenance = up to 17
variations
Registration in Europe
• Marketing Authorisation Procedures
• Post-Approval Procedures (Cont’n):
– Renewal
» in Europe, the MA is valid for 5 years
Specific situation of all new approved Products for the first
5 years:
Periodic Safety Update Report (PSUR)
6 monthly - 2 years after authorisation
Annually for the subsequent 2 years
At the first renewal
5 yearly renewals
» renewal mainly based on the pharmacovigilance data and the
benefit to risk ratio
» to be applied at least 3 months before expiry date
Registration in Europe
Future outlook
Revision proposed July 2001
• To complete the single market
• To increase transparency
• To favour competitiveness of the industry
• To prepare EU enlargement
Registration in Europe
Future outlook
Revision proposed July 2001
• Scientific expertise to be reinforced
• Increased scientific advice to companies
(in particular for small sized companies & biotech companies)
• Faster access to highly innovative medicines
– Fast track registration procedure
– Conditional marketing authorisations
Registration in Europe
Future outlook
Innovation for the benefit of the patients
Timeframes
• Centralised procedure: EMEA: from 210 days (normal
authorization) to 150 days (fast-track); Decision-making:
Member States consultation: reduced from 30 to 15 days;
streamlined Commission procedure (new comitology);
Expected total: +/- 270 days (currently +/- 1year)
• National procedures: from 210 days (now) to 150 days;
• Decentralised procedure: from 300 days (now) to 210 days.
• Target: all procedures below 1 year (International best
average standard)
Registration in Europe
Future outlook
Promoting Industry competitiveness
and competition
• Administrative Data protection periods to be harmonised
between Member States (10 years)
• Possible one year extension in case of additional
innovative indications bringing important clinical benefit
for the patients
• Possibility for generic companies to perform trials before
patent(s) expiry (“Bolar” type provision)
Registration in Europe
Future outlook
Cutting the red-tape reduction paper flow
• Removal of the five year renewal rule for marketing
authorisations
• Strengthening pharmacovigilance in particular through
systematic electronic exchange of data
• Accelerated and simplified decision-making process