Harmonization of data requirements

Harmonization of data requirements for this diverse group of compounds is being undertaken in a stepwise fashion. 

Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, 18 702 International Convention for the Protection of Industrial Property, 25 263, 267 International copyrights, 7 794—795 International Council of Scientific Unions Committee on Data (CODATA),... 

In November 1991, in Brussels, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was held. A new topic was proposed to, and accepted by, the ICH Steering Committee. This was the thorny issue of tripartite mutual acceptance of foreign data. It was assigned the prefix E5 (efficacy, fifth topic approved) but was to be one of the slowest to be resolved - as the reader by now will appreciate, slowly resolved because of its complexity, not... 

In addition to those items previously mentioned, the FDA is also participating in the development and use of international standards to facilitate pharmaceutical development. The goals of the International Conference on Harmonization of Technical Requirement for Registration of Pharmaceuticals for Human Use (ICH) is to facilitate the mutual acceptance of data submitted in support of drug marketing applications by the European Union, Japan, and the United States. The ICH has developed a number of guidelines and standards to harmonize post-marketing surveillance efforts on an international level. 

It might not be immediately apparent that the drive towards harmonization of regulatory requirements had its birth at the first meeting of the CPMP in November 1976. The CPMP at that juncture had been established to operate a mutual recognition procedure, laid out in Directive 75/318, but it had no work to do initially. It was, however, immediately clear to the CPMP that the data re-... 

Annex I inclusion of an a.i. is the result of a harmonized evaluation and decisionmaking procedure, performed on the basis of harmonized data requirements, as detailed in Annexes II and III to the Directive. 

Harmonization of Environmental Chemistry and Fate Data Requirements Under NAFTA, Regulatory Proposal PRO 2001-02, Health Canada, Pesticide Regulatory Management Agency. Also available on the World Wide Web http //www.hc-sc.gc.ca/pmra-arla/english/pdf/pro/pro2001-02-e.pdf. 

The first edition1 of this book was published approximately 13 years ago. Its primary objective was to present an overview and a "roadmap" of the process of new drug discovery and development, particularly oriented to individuals or companies entering the pharmaceutical field. It was written by one of the authors (Smith), with no contributors, and drawn on Smith s experiences in the industry and field over the course of nearly 40 years. In the second edition, the scope of the first book has been expanded and technical details in the form of hard data have been included. In addition to the editors own commentary and contributions, the major part of the book is the result of contributions of experts in the industry. New chapters on risk assessment, international harmonization of drug development and regulation, dietary supplements, patent law, and entrepreneurial startup of a new pharmaceutical company have been added. Some of the important, basic operational aspects of drug discovery and development (e.g., organizational matters, staff requirements, pilot plant operations, etc.) are not repeated in this book but can be found in the first edition. 

It is clear that the fundamental tenets of safety, quality, and efficacy should remain but considerable scope exists to produce a more easily understood core of requirements among which the subject of risk analysis should also be included. International harmonization cannot be mandatory either for government or for industry. Nevertheless, a commitment can and should be entered into both by individual governments and by pharmaceutical associations to accept specific guidelines that have drawn up and agreed. Such a commitment would preempt the demands to provide additional data requirements unless the scientific validity of such requirements were proven (53). 

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