Dr Chang Hong-Jen, Vice President of the TRPMA, expressed that the drug review system and relevant regulations have to be brought into line with international practices, because they are the foundations for the industry.
Dr Chang pointed out that the US, with a population or 30 million, is the leader in new drug regulations. The development of the biotech industry in Taiwan has been affected by the size of the domestic market, over conservative regulations and the authorities’ lack of relevant knowledge.
Dr Chang was a former General Director of the NHIA and the Deputy Minister of the MOHW, he is one of the few people in the industry who have the first-hand experiences in both the industry and the government. Dr Chang expressed that regulations should not be on obstacle to the industry’s development. He hopes the judicial authorities modernize the regulatory system.
The summary of the interview with Dr Chang:
Q: Why the US dominates the new drug innovation?
Chang: The global drug market used to be dominated by the US, the Europe and Japan before the booming of the Chinese market. Japan opted for the protectionism at the end of last century; and the Europe embraced the social insurance system. Hence, the US became the only free market, in which drug companies are free to set drug prices. That’s why most drug companies choose the US as the first new drug launch country. As a result, the US set the drug regulations for the global market.
What attracts drug companies to launch their products in the US is its market size, rather than its relaxed regulations. In fact, the drug regulations in the US are quite stringent.
**Q: How does the US, as its regulations are stringent, become the pioneer in new drug R&D? **
Chang: The regulatory system is critical to new drug R&D; however, it should not be an obstacle. The regulations in the US are stringent, but flexible and innovative. The system can quickly be adapted to new situations, such as new diseases and new technology.
For example, the US government established a fast-track system and quickly approved the first AIDS new drug at the end of 1980.
In 2012, the US FDA put forward the Innovation Act, which aims to expedite the launch of new drugs through four approaches: fast-track review, breakthrough therapy, expedited approval and priority review. Any drugs designated by the US FDA as innovative drugs will receive full support from the health agency with a view to brining the drugs to the market as early as possible.
**Q: What’s your view on the new drug regulations in Taiwan? **
Chang: The focus of new drug R&D is more about data than about regulations. At present, the regulatory system in Taiwan is still behind the international standard. The government decided to establish the National Center for Drug Evaluation to streamline the drug review procedure. The industry welcomes this policy and hopes this national center can significantly improve the drug review efficiency. As for the judicial authority, it should not interfere in the industry’s development; instead it should proactively acquire new knowledge so as to fit its purposes.
Translated by TRPMA
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