Medicines Regulatory Harmonization: International Collaboration as a Key to Improve Public Health:

摘要

Over the past 30 years, many national drug regulatory authorities have embarked on a process of gradual harmonization of all the technical aspects of studies, processes, and tests that generate the data necessary to support claims of quality, safety, and efficacy of medicines. This has been mainly a trade-driven process characterized by “region-specific” harmonization initiatives; the less-resourced authorities started this processes much later than the better-resourced ones. The immediate outcome of harmonized requirements is the eliminating of country-specific tests and studies, and the narrowing of gaps in the interpretation of data. This reduced the costs for pharmaceutical companies by enabling them to develop one single set of data and documentation to be submitted to several different countries. In addition, the harmonization processes are beneficial for public health: open-minded technical discussions and the exchange of ideas and experience among regulators of different countries contributes to strengthening the capacity of national authorities to expedite the assessment of priority medicines, and to filter out unsafe or substandard products.