M4, common technical

Committee for Proprietary Medicinal Products. ICH M4. Common Technical Document for the Registration of Pharmaceuticals for Human Use - Organisation CTD, CPMPIICHI2887I99. London CPMP, 1999. 

Guidance on the content of the Nonclinical Overview (NCO) is given in ICH M4S, Common Technical Document for the Registration of Pharmaceuticals for Human Use—Safety, CHMP/ ICH/2887/99 Rev 1 Safety. This guideline also gives information on the structure and content of the narrative and tabular summaries that contain the more detailed information. 

FIGURE 10 Schematic illustration of the ICH M4 common technical document (CTD) the contents of the Quality Overall Summary (2.3) and Quality (3) modules are most relative to PAT. 

ICH Multidisciplinary Guidelines M3 (Timing) and M4 (Common Technical Document)... 

Figure 6.1 Diagrammatic representation of the organization of the Common Technical Document (CTD) (from ICH M4 Guide).

M4(R3) Common Technical Document Superstructure document granularity... 

The common technical document (CTD) (ICH M4) is now a requirement. The CTD is the agreed common format for the preparation of a well-structured application to the regulatory authorities and has had an impact on all organisations as database integration and electronic submissions become more common. 

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... 

The ICH Q8 guidance is currently being developed and is expected to reach the ICH Step 2 in November 2004. It is intended to provide guidance on the contents of Section State-of-the-the-Art Pharmaceutical Science. P.2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH topic M4). 

International Conference on Harmonization (ICH) (2004), M4 Organisation of the common technical document for the registration of pharmaceuticals for human use, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH, Geneva. 

International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH). Topic M4 Organisation of Common Technical Document for the Registration of Pharmaceuticals for Human Use CPMP/ICH/2887/99. London European Agency for the Evaluation of Medicinal Products, 2000. International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH). Topic Ml Medical Terminology (Draft). Available at hllp //www.ifpma.org/ich5e.html. Accessed July 21, 2001. 

Box 16.1 Extract from the Organisation of the Common Technical Document (M4)... 

The ICH M4 guideline provides the agreed-upon common format for the preparation of a well-constructed Common Technical Document (CTD) for applications that will be submitted to regulatory authorities for marketing approval. The goals of using a common... 

This chapter has described and discussed the various modules of a Common Technical Document (CTD) as presented in ICH M4. A sponsor preparing a marketing application for submission to any of the three ICH regions and to most other regulatory authorities around the world can, and probably should, utilize the recommend orders of presentation outlined in the ICH CTD guideline for quality, nonclinical, and clinical results generated to support the characterization and development of a drug candidate. 

Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD) ICH, 2001) The CTD provides for a harmonized structure, content, and format for new product applications. The document is divided into four separate sections. The four sections address the application organization (M4 organize), the quality section (M4Q), the safety section (M4S) and the efficacy section (M4E) of the harmonized application. Drug metabolism and pharmacokinetic data should be summarized in the safety section that includes the nonclinical overview, nonclinical written summaries, and nonclinical tabulated summaries. More specifically, in Section 2.6.4.S metabolism (interspecies comparison) of the written summaries, the following data should be included ... 

It should be noted that one of the ICH topics (M4) currently under discussion is a common technical document suitable for registration of medicinal products in the EC, USA and Japan. The draft requirements are at an early stage, and any harmonisation of requirements is likely to be an involved procedure given the currently differing regulatory practices in the three participating regions. 

---