EU

1
EU ??? ??? ??

• ? 1? QC/QA Workshop
• (2003? 8? 25? )
• ? ? ?
• MJ Pharma

2
Terminology

• ASM Active Substance Manufacturer
• CEP Certificate of Suitability to the
  Monographs
• of the European Pharmacopoeia,
• called sometimes as COS
• CTD Common Technical Document
• EDMF European Drug Master File
• ICH International Conference on
  Harmonization
• MA Marketing Authorization
• MRP Mutual Recognition Procedures
• NTA Notice To Applicants

3
EU ??? ? ????? ??

• ? EU ??? ? ????? ??? ?? ????? ?? ??????
  ?????? ? ????? ???? ?? ?? ????? ????(MA) ?? ?
  ??? ??? ?? ?? ????? ?? ??? ??? ?? ???? ????? ??
  ??.
• ?, ??????? ?? ? ????? ??.

4
EU ??? ? ????

• 1. National Authorization (Decentralized
  Procedure)
• - ???? ???? ??
• - EU ? ?? ??? ????
• - ??????(MRP)? ??? ?
• 2. Community Authorization (Centralized
  Procedure)
• - ?????? ? ???? ??? ??? ???? ??
• - EMEA (European Agency for the Evaluation of
  
• Medicinal Product)? ????? CPMP ?? ????
• - Single MA in EU

5

????? ??????(MRP)

• 1. 1998? 1? 1??? ??? ??
• 2. Centralized Procedure? ??? ?? ???? ???
• ?????? ??? ??
• 3. ???? EU? ?? ??? ????? ? ?? ?? ?
• ???? ? ??? ????? ???? EU?????
• ???? ?? ??
• 4. ??? 5?? ??

6

MA ????? ??

• 1. Centralized Procedure? ?? ???, Mutual
• Recognition? ??? National Procedure? ?? ???
• MA Application Dossier? ?? ??? ???.
• 2. MA ???? Format Change
• From 1st July 2003,
• All new applications should be made in accordance
• with the EU-CTD Format
• NTA Format ? CTD Format

7


MA ????? ??

• NTA Format
• Table of Contents 4 Parts
• Part 1. Summary of the Dossier
• Part 2. Chemical, Pharmaceutical and Biological
  
• Documentation
• Part 3. Pharmaco-Toxicological Documentation
• Part 4. Clinical Documentation

8


MA ????? ??

• CTD Format
• Table of Contents 5 Modules
• Module 1. Administrative Information and
  Prescribing
• Information
• Module 2. Common Technical Document Summaries
• Module 3. Quality
• Module 4. Non-clinical Study Reports
• Module 5. Clinical Study Reports

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CTD Format
Diagrammatic Representation of the Organization
of the CTD

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CTD Format (Introduction)

1. What is the CTD? The CTD is an
internationally agreed upon format for the
preparation of a well structured presentation for
applications to be submitted to regulatory
authorities in the three ICH regions of
Europe, USA and Japan. 2. Purpose of Format
Change It is intended to save time and
resources and to facilitate regulatory
review and communication.
11

CTD Format (Introduction)

• 3. Preparing and Organizing the CTD
• Text and Tables
• A4 Paper, Sufficient margin in the
  left-hand,
• 12-point Font of Times New Roman
• Abbreviations
• Define in the first time used in each
  module

12

CTD Format (Module 1)
Module 1. Administrative Information and
Prescribing Information Module 1.1
Comprehensive Table of Contents Module 1.2
Application Form Module 1.3 Summary of Product
Characteristics, Labeling
and Package Leaflet, etc Module 1.4 Information
about the Experts Module 1.5 Specific
Requirements for Different
Types of Application Annex
Environmental Risk Assessment
13

CTD Format (Module 2)
Module 2. Common Technical Document
Summaries Module 2.1 Overall CTD
Table of Contents Module 2.2 Introduction
Product profile Module 2.3 Quality Overall
Summary Expert report Module 2.4 Non clinical
Overview Expert report Module 2.5 Clinical
Overview Expert report Module 2.6 Nonclinical
Written and Tabulated
Summary Module 2.7 Clinical Summary
14

CTD Format (Module 3 4)
Module 3. Quality Module 3.1 Table of
Contents Module 3.2 Body of Data Module 3.3
Literature References Module 4 . Nonclinical
Study Reports Module 4.1 Table of
Contents Module 4.2 Study Reports Module 4.3
Literature References
15

CTD Format (Module 5)
Module 5. Clinical Study Reports Module
5.1 Table of Contents Module 5.2 Tabular
Listing of All Clinical Studies Module 5.3
Clinical Study Reports Module 5.4 Literature
References
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Body of Data (Module 3.2)

• 3.2.S Drug Substance
• 3.2.S.1 General Information
• 3.2.S.2 Manufacture
• 3.2.S.3 Characterization
• 3.2.S.4 Control of Drug Substance
• 3.2.S.5 Reference Standards or Materials
• 3.2.S.6 Container Closure System
• 3.2.S.7 Stability

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Body of Data (Module 3.2)

• 3.2.P Drug Product
• 3.2.P.1 Description and Composition of the
  Product
• 3.2.P.2 Pharmaceutical Development
• 3.2.P.3 Manufacture
• 3.2.P.4 Control of Excipients
• 3.2.P.5 Control of Drug Product
• 3.2.P.6 Reference Standards or Materials
• 3.2.P.7 Container Closure System
• 3.2.P.8 Stability

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????? ???? ??? 3?? ??

• 1. CEP
• Data 3.2.S? ???? ??? CEP Copy ? ??,
• (CEP ??? ?? ??? Application ??)
• EP????? ??? ?????? ?? ???? ??
• 2. EDMF
• Data 3.2.S? ???? ??? EDMF ??? ??,
• ????? ???? ????? ?????? ?? ??
• 3. Full Details of Manufacture
• Data 3.2.S? ???? ??? MA??? ????,
• ????? ???? ????? ?????? ??

19

CEP

• 1. 1993?? ??? ??
• 2. ?????? ?????? ??? ? ??? ?? ?????
• ?????? ? ??? ??? ??? ?? ??? Control ?
• ? ???? ???? ??
• 3. ????
• EDQM (European Directorate for the Quality of
  Medicines)
• Strasbourg, France

20

CEP
21

EDMF

• 1. Applicant Part (Open Part)
• ????? ???(ASM)? ?? ????? ?????
• (Applicant)?? ???? ???? MA??? ??? ?.
• Applicant? ??? ?????? ??? ????? ???
• ???? ?? ??.
• 2. ASM Restricted Part (Closed Part)
• ASM? ?? ??????? ???? ??. ????? ??
• ?? know-how? ?? ??.

22

EDMF
23

Scheduling for EU Registration
? CEP Procedure ?? ?
Product Launching (Patent Expiry)
???? ????? ??? ?? ?? ? ??? ???? ??? ? ??.
24

Scheduling for EU Registration
? EDMF Procedure ?? ?
???? ????? ??? ?? ?? ? ??? ???? ??? ? ??.
25

References

• 1. http//pharmacos.eudra.org/F2/eudralex/vol-2/ho
  me.htm.
• 2. Note for Guidance on Summary of Requirements
  for Active
• Substances in Part? of the Dossier
  (CPMP/QWP/297/97)
• 3. Certification of suitability of the monographs
  of the
• European Pharmacopoeia Resolution AP-CSP
  (99)4
• 4. The Rules Governing Medicinal Products in the
  European
• Union, 1998Ed. Vol. 3A Quality Guidelines
  European Drug
• Master File Procedure for Active Substances
• 5. http//www.suregmp.com/academy/academyform.asp

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Questions?

• MJ Pharma, ?? ???
• ????? ??? ??? 837-17 ????? 713?
• Tel. [phone]
• Fax [phone]
• E-Mail kscho_at_mjpharma.pe.kr