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Phasing-in CP - how to handle existing, ongoing and - ARPharM

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Phasing-in CP - how to handle existing,
ongoing and future Community Marketing
Authorisations
Innovative Industry Perspective
Anu Tummavuori
Manager EU Regulatory Affairs and Liaison
F.Hoffmann-La Roche Ltd
Anu Tummavuori
1
Overview
• EU Regulatory Environment
• Enlargement and NML
• CP licenses and PALC
• Practical issues
• Learning’s from 2004
Anu Tummavuori
2
The „Pharma“ Landscape in Europe
> 40 Years of Significant Achievements
EU 12
EU 15
Candidate Countries
CADREAC
ACCESSION EU 25
NEW WAVES
PERF III
PERF II
Phasing-in
Implementation
of the New Law
PERF I
Part of the Acquis Communautaire
Reg/Directives+++++
Codification Dir./Regul.
1965
Slide: Jacques Mascaro, Roche
New EU Pharma Law
Oct-Nov �05
Anu Tummavuori
3
The „Pharma“ Lanscape: Future
More Prominent Centralised System
EU 12
EU
Candidate Countries
Law
Guides
EMEA Road Map clear objectives
EU HMA�s
15
ACCESSION EU 25
PERF III
EMEA
EMEA
EMEA
PERF II
CADREAC
RoadMap
RoadMap
RoadMap
NEW WAVES
Position of HMAs
Balancing EUImplementation
versus other Regions
Phasing-in
of the New Law
EU
PERF
I within global environment (WHO, ICH7)
More Competition within EU for CP
Part Strategy
of the Acquis Communautaire
of response
faster and
Newfaster
EU Pharma Law
Reg/Directives+++Capacity
Codification
Dir./Regul.
1965
1965
Slide: Jacques Mascaro, Roche
> 2006
Anu Tummavuori
Oct-Nov
�05�05
Oct-Nov
4
Enlargement 2004 vs 2007
2004: EU 15 was very different from EU25
- 10 New Member States
- New Medicines Legislation
- Clinical Trials Directive
- EMEA Roadmap
2007: Changes implemented/implementation
ongoing in EU27
- Paediatric regulation
Anu Tummavuori
5
NML CP Key Procedures and
Co-marketing & coProcesses
promotion allowed
Revised Exceptional
Circumstances
New Conditional
Approval
Accelerated
Assessment
Revised & new:
Annexes
Braille
User testing
Shortened
DMP
Revised EMEA function
and structure
Renewals
NML
Revised
Reg 76/2004 (20 Nov 05)
Extended scope
of Centralised Procedure
Revised
Dir 2004/27/EC (30 Oct 05)
Data Protection
New
Increased
Sunset Clause
Transparency
Strenghtened
New EMEA Roadmap 2010
Pharmacovigilance
Anu Tummavuori
6
CP Licenses
What happens between 31.12.2006 and
1.1.2007?
31.12.2006
1.1.2007
Commission Decision
25 + 2 countries
20 (21) +2 languages
BG
Commission Decision
27 + 2 countries
22 (23) + 2 languages
RO
HR
Originals & Generics
HR
Anu Tummavuori
7
Phasing-in of products with regulatory
activities
1.1.2007
CHMP Opinion
Oct/Nov 06
Decision Making Process
Translation of 2 new languages
with the opinion (Annexes)
2 new languages part of opinion
2 new CHMP members included in voting
CHMP evaluation and opinion
DMP
CHMP evaluation
and opinion
Anu Tummavuori
DMP
8
Phasing-in of CP licenses
- PALC and opinions
• Voluntary pre-linguistic checking process (PALC)
80-day procedure
EMEA coordinating
20 products/submission slot, last scheduled for 1.10.06
Increase of # products or slots needed to handle
products with late opinions
• Submission of translations for ongoing procedures
Need to bring PALC and opinion together – take care
with timelines
Need to identify differences
Anu Tummavuori
9
CP Products: How did we work
in practice to integrate 10 NMs?
Voluntary
PALC
Process for
New Languages
Jan 06
New Languages
Part of CHMP
Opinion
1 Jan 07
Anu Tummavuori
2007
10
Phasing-in of CP licenses
- documentation
• Submission of documentation for ongoing procedures
Details needed from the EMEA for
applicant/MAH – are members known?
MAH is not informed on sending of AR’s – need
to know as of when to coordinate
• Submission of certain variations needed until accession
e.g. safety related
Anu Tummavuori
11
Phasing-in of CP licenses
- address list
•Addresses need to change for all packs (EU27)
EMEA guidance published July
name & tel # (address & e-mail optional)
ISO codes; countries can be combined
list only once
pack sizes & strengths can be combined
• EU 27 list needed for nMS packs
• To be done either
a) with ongoing variation
b) art 61(3) notification
Anu Tummavuori
12
Phasing-in of CP licenses
- supply of products
• After Accession it is no longer possible to
release product on the market according
to national approval
• Careful planning and stockpiling of products
needed to guarantee availability
• 12 months needed for the implementation of EU packs
for New Member states
Anu Tummavuori
13
Annexes
• Applies to EU27
• New languages to be included in opinions for all
procedures with 67-day DMP as of October
MAA/Annex 2
Renewal/Annual Re-assessment
Referral
• New languages to be included in opinions for all
procedures with 44-day DMP as of November
Variations Type II
• Type I variations – as of December?
• Accelerated Assessment DMP – to be discussed
individually
Anu Tummavuori
14
CP Learnings from 2004
• No Commission Communication
Some issues as no language version available fro P&R (no
national
approval anymore)
Communication would have provided clarification
• Maltese
Derogation for 3 years
What will happen after?
Anu Tummavuori
15
CP practicalities
How did we adapt for the changes?
• More workload on the Annexes translations but same
timeline for the post.-opinion translation phase
Updated our internal pre/post opinion translation
process
• Training of affiliates + product responsibles
• Affiliates network changed
• Updated our dispatch requirement for documentation as
new organisation at the CHMP level
• All functions, especially business, needed to understand
the impact of EU25: EU as a stronger partner
• Effective launch in EUAnu
25Tummavuori
16
New CHMP post-2004 accession and
NML
• Rapporteurship stayed with the same delegation
• Pool of 59 (30 +25+4) for rapporteurship
Industry choice will disappear
• Less predictable – will consensus be possible?
• Sci Adv more important
• What is the impact of SAGs?
• What will be the impact of peer review?
Anu Tummavuori
17
CP Learnings
• Working together was essential
Positive experience!
• Pragmatic approach needed with
collaboration and communication
• No need to re-invent the wheel
Anu Tummavuori
18
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