The objectives of pharmacy administration that the Department of Health is diligently pursuing are to keep up with the current trend in global pharmacy administration, to seek the greatest welfare for the health of the populace, and to improve the quality of life. In order to achieve rapid growth and development of the pharmaceutical industry in Taiwan, and to enter and compete in the international markets, it is necessary to improve the quality and quantity of new drug approval through combined wisdom and efforts of the government, the researchers, the industry, and the public.

In order to establish a system to ensure drug safety, to encourage pharmaceutical research and development, to assure protection for discoveries and intellectual property, and to improve the quality of domestic clinical trials, the Taiwanese government made revisions, in 1993, to the existing regulations for safety monitoring of new drugs. To register a new pharmaceutical product, it is mandatory to conduct a domestic clinical trial with a minimum of 40 subjects, in addition to submission of relevant documents in accordance with the existing regulations. Although conduction of this type of registration trials can demonstrate the potential efficacy, provide valuable information on adverse reactions to the drugs and promote appreciation of the value of clinical trials, data obtained from such trials may not be statistically sufficient to prove the safety and efficacy of the drug.

To achieve the multiple goals of ensuring drug safety for the populace, encouraging drug research and development, promoting constant innovation of pharmaceutical products, minimizing expenditure on drug research and development, and raising the standards of domestic clinical trials, the Department has announced, on five occasions since 1998, the conditions for waiving domestic clinical trials. On December 12th 2000, the “Double Twelve Announcement” replaced the “July Seventh Announcement” (#8246232) made on July 7, 1993 concerning the surveillance of drug safety. The existing requirements for clinical trials were amended to include Bridging Study provisions, which became effective on January 1, 2001. Bridging Study can generate data on pharmacokinetics/pharmacodynamics, efficacy, safety, and dosage in Taiwanese populations, thus enabling the extrapolation of foreign clinical trial data to relevant domestic populations. This will reduce clinical trial duplication and avoid wasting resources for drug research and development. The evaluation and verification of Bridging Study Data Package will be conducted in accordance with the ICH E5 Guidance.

In 2000, Japan, the United States and members of the European Union established The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). They collaborated into setting up a uniform standard in the process of drug research and development that are acceptable to all parties while maintaining the quality. These efforts were made to speed up the research and development process and to cut down the expenditure on drug research and development. Among all the issues, the most contentious involves how to manage “foreign data.” Dealing with this issue will act as the most important unifying step. This important, sensitive and contentious issue is discussed and in principle represented as ICH E5 Ethnic Factors (E is efficacy, 5 refers to the 5th inner criteria).

The future implementation of the Bridging Study in the Asia Pacific region will encourage the pharmaceutical companies to incorporate the Asia Pacific region in its research and development tactics at an early stage of drug research and development process. In this way, apart from saving the research and development resources being wasted, it will also enhance competitiveness of the Asia Pacific region in pharmaceutical research and development. At the same time, Taiwan will be able to get pharmaceutical products onto the market more rapidly, which will benefit the fight against disease. The department advanced the project of “APEC Network of Pharmaceutical regulatory Science-APEC Joint Research Project on Bridging Study” at the 17th APEC ISTWG Meeting held in August of 1999. This project gained the support of Singapore, Malaysia, the Philippines, Australia, and Mexico, and a common consensus was achieved between the delegates from each country. The First Workshop on APEC Network of Pharmaceutical Regulatory Science- APEC Joint Research Project on Bridging Study was convened in May of 2000, with the attendance of over 70 scholars from Taiwan and overseas. At the workshop it was decided to continue carrying out research related to the Bridging Study. In May of 2001, The 2001 Symposium on APEC Network of Pharmaceutical Regulatory Science- APEC Joint Research Project on Bridging Study was convened. Specialists from all over the world gathered together to inquire into the influence ethnic factors have on the safety and efficacy of drugs. The symposium participants came from more than 10 countries including Singapore, Malaysia, Japan, Thailand, South Korea, Hong Kong, Vietnam, Australia, the United States, the United Kingdom, Sweden, France, and Taiwan. In total, there were over 400 attendants. Discussion issues included the current situation concerning the implementation of the Bridging Study in the Asia Pacific region, mutual recognition of drugs between different countries, agreement to the exchange of information between countries, and the trend towards the development of standardizing technical data.

Current Taiwanese requirements on Bridging Study are relatively flexible. Working in harmony with the trends of international pharmaceutical regulations, the Department of Health also provides services of consultation and appraisal to the industry. These efforts are expected to achieve the goals of reducing the amount of research and development resources being wasted, speeding up the marketing of new drugs and benefiting the patients in the fight against diseases. In the future, the Department will review the stipulations related to the Bridging Study, in accordance with the latest ICH E5 developments.