Global registration and Life Cycle Management for APIs
Im Auftrag der ECA Academy

Global registration and Life Cycle Management for APIs Im Auftrag der ECA Academy

Vienna, Austria

Seminar Nr. 17504


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Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail:


Marieke van Dalen, Aspen Oss B.V., The Netherlands
Marta Miquel,  European Directorate for the Quality of Medicines (EDQM & Health Care), France
Dr Wilhelm Schlumbohm, Berlin, Germany
Dr Jan Smeets, Centrient Pharmaceuticals, The Netherlands


This education course is intended to provide guidance on the format, content and submission procedures for the pharmaceutical documentation of the quality of the drug substance for different types of dossiers, the CTD, the CEP and the European ASMF. In this context the consequences of the guidelines on Elemental Impurities (ICH Q3D (R1)) and genotoxic impurities (ICH M7) will be considered. Furthermore, the impact of the variations regulations will be discussed.

Participants will have the opportunity to choose 2 out of 3 parallel workshops:
  •  Stability studies and establishing a retest date
  •  Description of the manufacturing process
  •  Top ten deficiencies in new applications for Certificates of Suitability for chemical purity


In Europe there are several ways to document the quality of the drug substance for the purpose of marketing authorisation:
  •  Certificate of Suitability of the pharmacopoeial monograph (CEP)
  •  Full details of manufacture (according to CTD Module 3 Quality of Drug Substance)
  •  European Active Substance Master File (ASMF; former Drug Master File, DMF)
  •  Other evidence of suitability of the pharmacopoeial monograph
In the US, the quality of the drug substance can be documented as part of the CMC Dossier or in a US-DMF.


The education course is designed for all persons involved in the compilation of pharmaceutical dossiers for marketing authorisations who want to become familiar with the different ways to document the quality of the drug substance for the purpose of marketing authorisation in Europe. Furthermore, the course will be of interest to personnel from Quality Units of the medicinal products and the API industry.


Dossier Requirements for the Drug Substance – An Introduction

  •  Chemical pharmaceutical documentation for active substance(s) – Regulatory requirements in EU and USA
  •  Types of active substances – types of documentation
  •  CTD Module 3, CEP and ASMF (former DMF)
  •  CEP for a substance for TSE risk assessment

Requirements for the Certificate of Suitability to the European Pharmacopoeia

  •  Regulatory basis: Resolution AP-CSP (99)4 of the Council of Europe
  •  CEP Procedure
  •  Content of the CEP dossier with practical examples
  •  Administrative minor and major changes, 5-year’s revision

The European Active Substance Master File Procedure

  •  Regulatory background and scope
  •  The revised European ASMF guideline
  •  Applicant‘s and restricted parts - points to consider
  •  Questions & Answers on the ASMF procedure
  •  Recent European developments: Sharing of assessment reports, data bases ….

Pharmaceutical Impurities: Residual solvents, synthesis-derived and genotoxic and elemental  impurities

  •  CPMP-/ICH-Guidelines on Impurities and Residual Solvents
  •  ICH M7 Guideline on genotoxic impurities
  •  ICH Q3D(R1) Guideline on elemental impurities
  •  Specifying Impurities
  •  Classifying solvents, setting and proving limits
  •  Justification of Specification
  • Stability Data
  •  CPMP/ICH Guidelines
  •  Stability Summary and Conclusions, stability commitment
  •  Documentation of Stability Data
  •  Necessity for documentation of  raw data?

How to read and use a CEP

API Regulatory Starting Materials: how to defend their choice in a submission

  •  Why is this such a hot topic
  •  What guidelines to consider
  •  How to define a suitable starting material
  •  How to defend your choice in the submission
  •  What is different for generics
  • Consequences of a redefinition

Comparison of the CEP and DMF Procedure

  •  Advantages of the CEP procedure
  •  Handling Changes
  •  In which countries is the CEP being accepted?
  •  Cost Considerations
  •  Practical examples

Registration procedures in the US and Japan – what are the differences?

The EDQM inspection program

Registration requirements for APIs in emerging countries

  •  General remarks on API registrations in Emerging Countries
  •  Details of API registration in:
    • China  |  Taiwan  |  India  |  CIS countries: Russia, Belarus, Ukraine  |  Brazil  |  GCC countries
  •  APIC Emerging Countries Interest Group

Variations/Changes and life cycle management: in the EU, US and rest of the world

  •  Types and categories of API changes
  •  EU: the variation regulation and CEP revisions
  •  Handling API changes in the US
  •  Handling API changes in Japan
  •  Handling API changes outside these regions
  •  Initiatives to facilitate changes.

ICH Q3D – how to do in practice for APIs

Stability Studies and Establishing the Retest Date - Dr Jan Smeets

Description of the Manufacturing Process - Dr Wilhelm Schlumbohm

Top ten deficiencies in new applications for Certificates of Suitability for chemical purity - Marta Miquel

In order to prepare the lectures and the workshops in an optimal way, please send your questions to special topics to Ms Anne Günster, She will forward your questions to the responsible speaker. Thank you in advance for your cooperation.


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