Common Technical Document harmonisation

The main feature of the harmonisation is guidelines and Common Technical Documents (CTD). The CTD gives a harmonised format and content for new product applications and in 2003 there was an agreement on implementation, in USA, Europe and Japan. 

Figure 7.1 Common technical documentation. (Source ICH Harmonised Tripartite Guideline. Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use, M4, Step 4 Version (2004).)...

It was generally assumed that following the ICH 4 meeting in 1997 that International Harmonisation had reached an interim conclusion and that the future would focus on developing a Common Technical Document (CTD), to improve efficiency in documenting new medicines for regulatory purposes. However, the ICH process... 

Prior to the Conference, during which the ICH Expert Working Group and Steering Committee met, the ultimate objective of ICH 5 was achieved. The Common Technical Document (CTD) was agreed (see Table 19.6 for finalised CTD), setting out a harmonised format (see below) for regulatory submissions. 

In June 2004 the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) were issued by the TGA to replace the AGRDl. Under the ARGPM the format for registration applications in Australia is the Common Technical Document (CTD) developed through the International Conference on Harmonisation (ICH). 

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. 

International Conferences on Harmonisation. URL http // www.ich.org. The ICH Web site provides information on the structure and purpose of this consensus-building initiative, as well as the process for evolving recommendations regarding technical requirements for human drug registration worldwide. Separate sections address existing Guidelines, the Common Technical Document, and MedDRA. 

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. 

A regulatoiy submission will typically take the form of the Common Technical Document (CTD), which was developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Established in 1990, the ICH is a collaboration between the regulatory authorities and pharmaceutical industries of Europe, Japan and the USA their mission is to achieve greater harmonisation to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. ... 

Several steps have been taken towards a more harmonised methodology within the more general area of risk assessment of chemicals. The EU has proposed a number of principles for assessment of risks to man and the environment in directive 93/67/EEC (EC 1993) as well in the Technical guidance documents in support of directive 96/67/EEC on risk assessment (EC 2003), to further common practices in risk assessment. A harmonisation of national exposure limits is to be expected, since the EU sets both binding and indicative OELs for each member state to consider in its national regulations. However as noted by Vincent (1998) a full international harmonisation of OELs is unlikely and may not even be the most... 

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