The TFDA has a mission to ensure patients’ access to effective and safe drugs and to encourage the industry to engage in innovation. It means that the TFDA must create a friendly regulatory environment to help pharmaceutical companies go through the application process so that quality drugs can be available on the market as soon as possible.
First of all, the authority should have considerable foresight to make regulations adaptable to external changes. Secondly, the authority should communicate with the industry with great empathy in order to understand the faults of the system and put them right. By doing so, the regulatory system can therefore be the industry’s stepping stone to success rather than an obstacle.
Also, the regulatory system has to be brought into line with international practices. Taiwan’s entry into the ICH helps to close the gap in regulations with other countries. It will lower the entry barrier to the global market. Taiwan is keen to take part in international pharmaceutical regulatory affairs, for example, becoming a PIC/S member state, increasing the mutual acceptance of inspection reports, proposing the good review guidelines in the APEC meeting, etc.
The TFDA is also enthusiastic about reviewers’ training. It has signed memorandums with the authorities in Australia, Japan and the UK to encourage the communication in reviewers’ training and regulations.
As for keeping the review process transparent, the TFDA has made the names of experts in the review meeting available for the public’s access on the Internet. Drug companies can request for a face-to-face communication and a presentation in the drug advisory meeting. In 2014, the TFDA announced the accelerated review mechanism, which is applicable to drugs for unmet medical needs. The mechanism not only expedites the review process, but also strengthens post-market surveillance. So far, 26 new drug developers in Taiwan have enrolled for the guidance services.
New drug R&S used to be dominated by international drug companies. Over the recent years, the government has been coordinating support from various departments to encourage manufacturers in Taiwan to engage in new drug R&D activities. As the R&D capacity is growing, the industry urges the government to upgrade the regulatory agencies, for example to bring in more regulatory professionals, to promote the good submission practices and to implement post-market risk control, etc.
【2015-07-05/ Commercial Times】