Common Technical Document implementation

Readers may also be aware that under the auspices of the ICH a document is being developed on the organization of the Common Technical Document. It is intended that this will result in a common format (and, to at least some extent, content) of marketing authorization applications in the jurisdictions of those party to the ICH process (Japan, the EEA, and the United States). At the time of writing, a draft document had been circulated for comment. When adopted and implemented, this will result in a considerable amendment to the format and sequencing of information in a marketing authorization application. 

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. 

Common Technical Document (CTD). The meeting discussed the implementation of both the paper and electronic versions of the CTD with particular relevance to biotech products and new chemical entities. 

The common technical document (CTD) is a method of submitting an NDA. It is a very useful outcome of ICH discussions regarding the creation and implementation of standardized document formats. While individual regulatory agencies still have different requirements of specific content of various documents, this standardized format is a considerable step forward in the harmonization of submissions to multiple agencies. This guideline, adopted by the ICH regions (Europe, Japan, and the United States) in 2000, has subsequently been implemented, and other countries may continue to adopt it. 

Thus far, 37 guidelines aimed at both traditional and biotechnology-based products have been produced and are being implemented (Table 5). One of the ICHs most ambitious initiatives to date has been the development of the common technical document. This provides a harmonized format and content for new product authorization applications within the European Union, the United States, and Japan. When this and the other guidelines are fully implemented, considerable streamlining of the drug development and, in particular, registration process will be evident. This... 

If management decides to reject, modify, or delay implementation of a recommendation, it is a good practice to document the reasons for not accepting or implementing the recommendation as submitted by the investigation team. A common and avoidable mistake is to provide inadequate documentation for this decision. An example of inadequate documentation would be a brief entry in the record to the effect that this recommendation is not considered justifiable, with no further explanation. Examples of more adequate reasons for not accepting a recommendation may be the recommendation did not specifically address a root cause, or the recommendation is not technically feasible. In either case, an alternate recommendation should be presented. 

European Communities, 2009. Common implementation strategy for the Water Framework Directive (2000/60/EC). Guidance Document No. 19. Guidance on surface water chemical monitoring under the Water Framework Directive. Office for Official Publications of the European Communities, Technical Report 2009-25, Luxembourg, 222 pp. 

Systems engineering is a structured multidisciplinary approach to defining concepts and requirements for complex multifaceted problems that include conception, implementation, and validation. This is an ideal approach to developing solutions to clinical problems because they often involve more than one technical and clinical specialty. A concepts and requirements definition document creates a common interface that allows engineers and... 

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