Authorization Systems for Use of Unlicensed Medicines in European Countries:Implications for Establishment of Japanese System
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概要
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Authorization systems for use of unlicensed medicines in European countries were reviewed. The situations in the UK, France and Switzerland were mainly surveyed by close examination of the guidelines provided by the regulatory agency of each country. In addition, interviews were conducted with persons in charge of regulatory agencies, manufactures, importers and academic researchers in said countries. Comparison was made between European countries and Japan.In the three European countries, the use of unlicensed medicines was clearly positioned as an exemption from licensing of medicines. Use of unlicensed medicines must be considered on a last-resort basis and on a named patient basis. Prescription by doctors and reporting of adverse events were mandatory. On the other hand, in Japan, there is no specific requirement for the conditions for use of unlicensed medicines. It must be addressed that patients can import unlicensed medicines and the quality of medicines is not assured. While not many unlicensed medicines are in development in Japan, there are various needs for unlicensed medicines.Japan-specific system for use of unlicensed medicines should be established in consideration of the following; (1) Importation by patients should be restricted. (2) Importers must be given a license. (3) Reporting of adverse events by doctors should be mandated. The system should not depend much on pharmaceutical companies, in order to achieve a good balance between new drug development and aid of patients.
- The Health Care Science Instituteの論文
The Health Care Science Institute | 論文
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