Common Technical Document acceptance

Directive 75/318/EEC required that the dossier be presented in four highly structured parts Parts I, II, III, and IV. Directive 83/570/EEC was the amending Directive, which introduced the requirements for a draft SPC to be produced by the applicant. Volume 2B of The Rules Governing Medicinal Products in the European Union gave a detailed breakdown of the structure of a European regulatory dossier. This format was accepted until the end of June 2003 when a new format known as the Common Technical Document (CTD) became mandatory (see later). 

If harmonization can be achieved, as it has been, across sufficiently broad areas of quality, safety and efficacy, there is no logical reason why a common technical document (CTD) or dossier cannot be prepared that would be acceptable to all dmg regulatory authorities. Movement to a CTD would appear to be the next step toward further internationalization. 

The anticipated benefits to industry of this harmonized approach are straightforward. The need for duplicate studies in many clinical and biological areas is minimized. The common technical document will enable companies to prepare submissions more quickly, since a single technical dossier will be accepted by all authorities in the ICH areas. Overall, the drug development process will be streamlined, facilitating the process by which raw research is transformed into marketable drugs. 

Analytical scientists have welcomed ICH M4 Q—Common Technical Documentation (CTD) as a globally accepted format to provide information and scientific data in drug application submission. Recently, FDA and EU regulatory agencies have encouraged and allowed applicants for the electronic submission of the common technical documentations using ICH eCTD specification. 

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. 

This paper has attempted to be complete on the TLC of nucleic acids. We have reviewed historical documents, and demonstrated numerous contributions that have advanced the field. Critically, we have asked for a uniform approach this is important in all TLC, and is particularly helpful in making data comparisons. We have collated, and synopsized information that has been quite scattered in the TLC literature on nucleic acids. Our approach affords all chromatographers a seminal source to start with, not only in the literature, but also at the bench. We have included the most up-to-date material by searching common data banks over the last thirty years. We have also included new technical material that we have used successfully in our laboratory, and will enhance nucleic acid TLC, and characterization of unknowns, especially where expensive equipment is not available. We have also suggested a greater use of quantification of data by well-accepted methods. 

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