Page 340 - Chiral Separation Techniques

13.5 Guidelines from the International Conference on Harmonization 333

13.5 Guidelines from the International Conference
on Harmonization

13.5.1 Introduction

The International Conference on Harmonization of Technical Requirements for the
Registration of Pharmaceuticals for Human Use (ICH) is a tripartite body sponsored
by regulatory authorities and research-based industry representatives from the three
regions discussed above: the European Union, Japan and the United States. In addi-
tion, the ICH Steering Committee includes observers from the World Health Orga-
nization (WHO), the Canadian Drugs Directorate and the European Free Trade
Association (EFTA). It is the aim of ICH to promote international harmonization of
regulatory requirements. Such harmonization avoids the duplication of the develop-
ment work required for registering new medicinal products and is of importance to
the pharmaceutical industry which is becoming increasingly globalized.
The Steering Committee is responsible for identifying topics for which harmo-
nized guidelines are then developed. These guidelines can be obtained from the ICH
Internet web-site which is maintained by the International Federation of Pharma-
ceutical Manufacturers Associations (IFPMA) who provide the secretariat support
for ICH (http://www.ifpma.org). ICH also holds biennial conferences and work-
shops. There are five stages in the ICH process for developing a guideline, repre-
sented in Fig. 13-1, which starts with consideration of the topic and development of
a consensus by the relevant Expert Working Group (EWG). The EWG members are
nominated from the regulatory and industrial bodies in the three regions. The draft
consensus resulting from the EWG is then released by the ICH Steering Committee
for wider consultation in the three sponsor regions. Comments from other geo-
graphical areas are received through IFPMA and WHO contacts. The comments
received are consolidated and the final guideline is issued for adoption and imple-
mentation in the three regions.
Some internationally harmonized guidelines regarding specifications and tests,
impurities and validation of analytical methods have particular relevance to the
development of chiral drugs and are discussed below. In addition, the impact of work
on the common technical document is considered.

13.5.2 Specifications and Tests

ICH Topic Q6A Specifications: Test Procedures and Acceptance Criteria for new
drug substances and new drug products: Chemical Substances reached Step 4 in
October 1999 and was approved by the CPMP in November 1999 with a date of May
2000 (Step 5) for coming into operation in the EU [CPMP/ICH/367/96]. It provides
guidance on the selection of test procedures and the setting and justification of
acceptance criteria for new drug substances of synthetic chemical origin, and drug
products produced from them, that have not been previously registered in the EU,