Taiwan Looks to Promotion of Regulatory Science as Way to Boost Pharmaceutical Sector

Regulatory science may be one of the biggest trends in US and EU regulatory circles, but now that fervor is making its way to a new corner of the globe: Taiwan.

In a statement, Taiwan's National Cheng Kung University (NCKU) announced that it had set up a new Center for Pharmaceutical Regulatory Science, intended to "promote the administration and education of pharmaceutical regulation in Taiwan."

Regulatory science is, in simpler terms, the application of scientific methods, testing and techniques to the understanding of safety, efficacy and quality of healthcare products. The overall goal of regulatory science varies, but is generally intended to make sure approved products are safer, obtain approval more quickly or are manufactured in such a way as to decrease potential problems.

NCKU's program has the explicit support of Taiwan's Food and Drug Administration (TFDA), which signed a memorandum of understanding with the university on 25 March to help develop a pharmaceutical regulatory science program meant to promote, train and educate those involved in pharmaceutical regulatory affairs.

Regulatory science partnerships between the public and private sectors have been the method of choice for the US Food and Drug Administration (FDA), which has leveraged those agreements in numerous instances, most recently for a medical device regulatory science program in partnership with the Medical Device Innovation Consortium (MDIC).

NKCU said the first order of business for the regulatory science program will be the creation of a white paper on food and drug policy and the management of non-prescription medicines, which will in turn be used as a "national platform" on which TFDA can build.

A NCKU statement explained that the university eventually hopes to make the Center a university-level research center in the future, which could be used to help develop the pharmaceutical industry in the country.

The center will be led by Dr. Yea-Huei Yang Kao, who will serve as director, NCKU said.