Product registration, technical guidelines

The aim of the ICH is to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration and reduce or eliminate duplicate testing. This should result in better use of resources and eliminate unnecessary delay in the global development and availability of new medicines while maintaining safety guards on quality, safety and efficacy. 

As more than 95% of new medicines are worked out in the ICH regions the technical requirements for the safety, efficacy and quality of new medicines is determined at large by ICH technical guidelines. The application format for registration (marketing authorization) of new medicines in ICH and associated countries (such as Canada, Switzerland and Australia) has to follow The Common Technical Document (CTD) which provides harmonized structure and format for new product applications. This Common Technical Document is divided into four separate sections and 5 modules (see Fig. 1). The four sections address the application organization (M4 Organization), the Quality section (M4Q), the... 

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Stability Testing Photostability Testing of New Drug Substances and Products. ICH Tripartite Guideline Recommended for Adoption at Step 4... 

International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (2005) ICH harmonised tripartite guideline. Detection of toxicity to reproduction for medicinal products 8c toxicity to male fertility, S5(r2) current step 4 version parent guideline dated 24 June 1993 (addendum dated 9 November 2000 incorporated in November 2005)... 

This section mainly addresses the purpose and technical aspects of preclinical studies which are described and recommended in the registration guidelines of the EEC, Japan and the USA. The following brief descriptions of commonly used test procedures cannot replace the detailed study of guidelines by those who conduct these trials. They are intended to give the less experienced an idea about the safety standards, which have to be fulfilled by a medicinal product and about the purpose and conduct of these tests. This enables scientists in research and development to judge essential parts of a project for themselves and to make better and informed decisions. It also assists in planning time and cost of a project. 

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