the marketing authorisation holder (mah)
TRANSCRIPT
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For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
EMEA- Regulatory up-to-date topics -
Approval Procedure for Pharmaceutical Products
Dr. Nikolaus Mueller, V.MD, Ph.DHead of R&D OperationsNihon Schering K.K.
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2For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Contents
Expansion of EU- Legal Basis for EU Drug Approval Procedures
Revision 2001; Regulatory Bodies involved in EU Procedures
Submission Documents/ Centralized- vs Mututal Recognition Procedure
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3For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Expansion of EU -Legal Basis for EU Drug Approval Procedures
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4For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
The European Union
25 Member States21 LanguagesAbout 450 Mio citizensCouncil of MinistersEuropean ParliamentEU Commission
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5For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
The EU Member States
- Austria- Italy- Germany- UK- Netherlands- Belgium- Finland- Luxembourg- Denmark- Sweden- Spain- Portugal- Greece- France- Ireland
As of 1st Jan., 2004
- Slovakia- Slovenia- Malta- Cyprus- Czech Republic- Poland- Estonia- Lithuania- Latvia- Hungary
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6For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Background- History
EU a common market without any Trade- borders
Free Trade (including Drugs) among the Member States
New Drug- Approval- Procedure implemented in 1995- Central Procedure (highly innovative products)
- Mutual Recognition (general products)
2001 Revision; Review of Provisions of 1995 suggested
- Part of the new Revision accommodating accession of new EU Member States implemented in May 2004; remaining part in Sept./Oct. ‘05
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7For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Revision 2001;What are the new Regulatory Bodies?
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8For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Regulatory Bodies (1/3)
CPMP Committee for Proprietary Medicinal Products renamed to
CHMP Committee for Human Medicinal Products- Scientific Body of EMEA responsible for the evaluation of
medicinal products, both new and marketed products
- Consists of 1 representative of each EU member state plus Norway, Iceland and Liechtenstein (Before May 1, 2 representatives per country)
- Monthly meetings for 3 days
- Chairman: Daniel Brasseur from Belgium
- Co-Chairman: Eric Abadie from France
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9For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Regulatory Bodies (2/3)
CHMP working parties and ad hoc groups, e.g.- Biotechnology Working Party
- Efficacy Working Party
- Pharmacovigilance Working Part
- Joint CHMP/CVMP Quality Working Party
- Safety Working Party
- Scientific Advice Review Group
- Ad hoc Working Group on Blood products
- Herbal Medicinal Products Working Party
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10For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Regulatory Bodies (3/3)
MRFG Mutual Recognition Facilitation GroupMRCG Mutual Recognition Coordination Group
- Representatives from EU member states, Norway, Iceland, CADREAC observers
- Chairmanship by EU Presidency - Meets once a month in CHMP week
Task: - Coordination and facilitation of mutual recognition
procedure- provide a forum to reach common understanding of the
procedure and develop SOPs- Translate legal interpretations into practical
recommendations- Hold break-out sessions on individual applications in
order to facilitate agreement
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11For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Revision 2001;- Submission Documents- Submission Procedures
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12For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Submission Documentation
So far:- USA: New Drug Application
- Europe: Notice to Applicants
- Japan: Gaiyo
Common Technical Document
Mandatory for EU (centralized submissions) and Japan since July 2003
Mandatory for national submissions in EU from November 2003
US, highly recommended but yet not mandatory
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13For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
The Structure of the Common Technical Document (CTD)
Not part of the CTD
CTD
Dossier presented in a modularfashion
Logical order of documents, reflecting sequential pathway of drug development
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14For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Revision 2001;- Submission Documents- Submission Procedures
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15For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Possible procedures for approval in EU
Centralized Procedures- Mandatory for:
Biotech Products,Oncology, Diabetes, AIDS, Neurodegenerative diseases Orphan Drugs also open for NCEs
- Decentralized Procedure
Mutual Recognition Procedure- Possible for NCEs containing small molecules and known
chemical entities- National submissions
For products that will only be marketed in one EU Member State and line extensions to nationally approved products
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For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
The Centralised Procedure
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17For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
The Products Eligible
List A Products(mandatory)
List B Products(optional)
Products developed by:• Recombinant DNA
Technology• Gene-Technology• Antibody Methods
• Innovative Products Processes, Manufacturing Methods, delivery systems
• Therapeutic Interest• Products from human
blood or plasma• New Active Substance
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18For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Centralised Procedure (1/2)
day 70 day 120 day 121
Procedure start after CHMP (Committee on Human Medicinal Products) Meeting
Submission of responses and restart of
the clock
Preliminary assessment
report
Consolidated list of
questionsClock stop
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19For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Centralised Procedure (2/2)
Restart of clock and
oral explanation
Adoption of CHMP
Opinion
Trans-mission of opinion to
EU Commission
EU Commission decision and
final approval
Clock stop if oral
explanation is needed
For appeal to this decision
day 181 day 210 day 240 ~90 days laterday 180 15 days
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20For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Commission Decision
CHMP opinion and annexes
Sent to Commission
Sent to Member States and applicant
30 days
Draft Decision
Standing CommitteeWritten Procedure
30 days
No objectionsCommission Decision
30 days
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21For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
The Outcome
Marketing Authorization Granted by the EU-Commission
Results in one European Approval
Harmonized SPC (Summary of Product Characteristics) and PIL (Packaging Insert Label)
Variations Regulated by Regulation 542/95
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For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
De-centralised Procedure;modification of the Centralized Procedure
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23For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
New Decentralized Procedure
Similar Process as for Centralized Procedure but
Choice of Rapporteur possible
Selection of participating countries possible
No possibility to withdraw application after process was started
MRCG to coordinate process in case of differing opinions
- arbitration last resort.
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For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
The Mutual Recognition Procedure (MRP)
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25For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Relevant aspects of the MRP
MRP can be initiated by the Applicant or the Member States
Concerned Member States and Reference Member State can be selected by the Applicant
Based on the Assessment Report and the Marketing Authorisation of the Reference Member State (RMS)
Marketing in RMS possible after Marketing Authorization (before and during the MRP)
Can also be used for elder products
Withdrawal (from selected countries) possible
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26For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Mutual Recognition Procedure - National Phase
Submission to Reference Member State (RMS)Assessment Phase
210 days + ~150 days ~90 days? ~60 days 90 daysclock stop
Clock Stop for reply
preparation
Assessment Report
Assessment of reply
Deficiency Letter Approval
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27For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Mutual Recognition Procedure - MR Phase
Submission by affiliates to CMS (Start day scheduled with CHMP meeting plan)
Validation Period by
CMSObjections Submit reply
MRFG (Mutual
Recognition Facilitation
Group)
Final Decision
National decisions
10 days day 50 day 60 day 75~7 days day 90 ~30 days later
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28For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
If Mutual Recognition cannot be achieved and no decision for withdrawal!
Serious Public Health Concern
remains
Serious Public Health Concern
remains
Within 90 daysReferral to CHMP
Within 90 daysReferral to CHMP
Within 60 days CHMP opinionWithin 60 days CHMP opinion
Company Appealpossible
Company Appealpossible
Within 60 daysFinal CHMP
Opinion
Within 60 daysFinal CHMP
Opinion
Commission decision
Commission decision
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29For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Submission Procedures
National Submissions:
- Initial phase same as MRP- Difference:
the Procedure stops with the approval of the RMS which is the only State where the applicant does want to market the Product
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30For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Summary and Conclusion (1/2)
Expansion of the EU into a Free-Trade-Community of 25 States has triggered the revision of the Marketing Authorization Procedure of Medicinal Products
Regulatory Bodies involved in EU Procedures have been newly set up
The National-, the MR-Route and the new Decentralised procedure result in National Approvals, while the Centralised Procedure ends with a Community Marketing Authorisation
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31For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Summary and Conclusion (2/2)
The community procedures (i.e. MRP, the Decentralised- and the Centralised Procedure) do result into a harmonized Summary of Product Characteristics (SPCs) and Package Insert Labels (PILs)
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32For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Aspects to be assessed during evaluation
Back-up
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33For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Revision 2001;What is new: Terms/ Procedures?
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34For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Definitions for medicinal products
Medicinal product is defined by the mode of action- pharmacological
- immunological
- metabolic
Borderline products are medicinal products by definition
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35For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Data protection
Rules harmonised all over the EU (8+2+1 rule)- Data protection for 10 years Europe-wide after first
marketing authorization
- Submission of data for generic application possible after 8 years (but not marketing)
- 1 year extension of data protection for originator, if during first 8 years after marketing authorisation an authorization for one or more therapeutic indication, withsignificant clinical benefit has been obtained
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36For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Support of generic industry
Bolar provision
EU reference product
Choice of procedure for centrally approved originator products (Centralised or MRP)
Bio-similar products, still to be accompanied by major data, however discussion about feasibilityhas begun
Derivatives can be considered to be the same
Most of line extensions are now included in a marketing authorization
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37For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Procedures
Centralised procedure: mandatory also for some indications (accelerated decision process, fast track procedures, conditional licence)
Mutual Recognition Procedure for products with an existing MA, Decentralised Procedure for products without MA
Both procedures result in mandatory arbitration in case of serious public health concern
Public Assessment Report for all procedures
Package insert now included in all procedures
Legal power for MRCG
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38For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Pharmacovigilance
More frequent safety reports- every 6 months for the first 2 years
- once a year for the following 2 years
- every 3 years thereafter
Increased co-ordination between MS
Use of MedDRA for safety reporting
Any regulatory action has to be reported immediately
Notification to competent authority if marketing of product is ceased
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39For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
GMP
GMP requirements for active substances and certain excipients (list for latter to be established by a directive)
Increased co-ordination and communication of inspection results via a community database
GMP certificates to be issued within 90 days after a successful inspection
Regular, unannounced and repeated and outside of the EC regulated
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40For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Other Provisions
Obligation of continous supply
Compulsory licensing possible
Compassionate use implemented
Sunset clause
Renewal only once after 5 years (submission 6 month before expiry the latest)
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41For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Important to know
Initiated by the Applicant
Reserved to certain kind of Products
Application made to the EMEA (all of the Member States)
Assessment made by the Rapporteur and Co-Rapporteur
Opinion (Majority Decision) by the CPMP
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42For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
MRP Flow Chart (1/2)
Continued to next page
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43For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
MRP Flow Chart (2/2)Continued from previous page
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For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
RenewalsVariations
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45For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Renewals
Currently:
Marketing authorizations (MAs) valid for 5 years, renewals to be filed 3 - 6 months before expiration
Future:
MAs have to undergo only one renewal after the first 5 years then valid indefinitely
and
„Sunset clause“: Products not marketed within 3 years after MA has been granted lose their MA
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46For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
Variations
All textual changes in SmPC, PIL and PackagingMaterial need to be approved prior to implementation. (Except Urgent Safety Restrictions)
Relevant Changes to the manufacturing of drug substance or drug product and/or release testing that impact the approved documents need to be approved prior to implementation.
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47For the 5th Kitasato University-Harvard School of Business Health Symposium / Oct.26, 2004Dr. Nikolaus Mueller, Head of R&D Operations, Nihon Schering K.K.
3 Variation categories
No Assessment- notification Type IA
- validity check
- implementation („tell and do“)
Assessment- short assessment Type IB
(as in current Type I) („tell, wait and do“)
- full assessment Type II