International regulatory submission

The basic elements and considerations for assay development, validation, and specification assignment are reviewed briefly. Assay development produces a method that requires validation for the analysis and release of materials (bulk or formulated finished product) for use in clinical development. The cumulative analysis of materials and stability considerations is then used to established specifications for internal and regulatory submission. 

The pilot plant and its staff play a critical role in technology evaluation, scale-up, and transfer activities of new products. These activities begin early in the development cycle and include technical aspects of process development and scale-up, organization and responsibilities of technology-transfer teams, documentation of the transfer process, and often preparation for an FDA pre-approval inspection (PAI). A properly designed and operated pilot plant can enhance the collection of scientific data necessary to support internal transfer activities, as well as regulatory submissions and FDA PAIs.P ... 

In 1991, the Commission of European Communities, the FDA, the Japanese Ministry of Heath and Welfare, the International Federation of Pharmaceutical Manufacturers Associations, the European Federation of Pharmaceutical Manufacturers Associations, the U.S. Pharmaceutical Manufacturers Association and the Japanese Pharmaceutical Manufacturers Association organized the first International Conference on Harmonization (ICH). The goal of the conference was to begin to harmonize requirements for regulatory submissions in the United States, Europe and Japan in the areas of quality, safety, and efficacy. One of the quality topics was stability testing. 

Massachusetts is one example). In less developed countries it may prove necessary to pay true fees together with consultation fees to government advisors. Sponsors will, however, need to take into account the costs associated with the effort of their internal regulatory staff in preparing CTX submissions (or their equivalent). 

Safety testing of chemicals is required under several directives of the European Union (EU) and international regulatory environments.1 Each of these legislative mandates requires submission of sound... 

Research reports are also emphasized in early development before regulatory documentation is required. However, recent changes with respect to reductions in the documents and extent of data that must be provided in IND submissions are increasing the importance of internal documentation through early clinical development (i.e., phases 1 and 2). Specifically, FDA guidances on IND CMC requirements have reduced the amount of data required for inclusion in the IND. Summaries are often allowed in lieu of detailed data. However, from both a compliance and historical perspective, it is critical to collect these data in a report for future reference. Thus, the documentation requirements overall have not been reduced but have been removed from the regulatory submissions and added to the in-house archives. 

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