Report from Taiwan

HUNG CHEI/FLICKR/GETTY IMAGESTaiwan is now a step closer to its goal to "promote the administration and education of pharmaceutical regulation" with the establishment of a new Center for Pharmaceutical Regulatory Science in the country by the National Cheng Kung University (NCKU). The center aims to promote pharmaceutical education and cultivate personnel training for pharmaceutical administration. Its mission also includes conducting research on pharmaceutical regulation and promoting international collaboration efforts, says Professor Yea-Huei Kao Yang, director of the center and professor of the Institute of Clinical Pharmacy and Pharmaceutical Sciences at NCKU.

Taiwan's regulatory system is comparable to that in America and Western Europe. In 2007, a health-technology assessment system was introduced for the pricing and reimbursement of new drugs. Taiwan also established its Food and Drug Administration (FDA) in January 2010 with a clear objective to establish a regulatory environment with drug-review mechanisms of international standards to run pharmaceutical affairs. Looking ahead to 2014, the agency commits to implementing the Pharmaceutical Inspection Convention Scheme (PIC/S) to help improve the quality of local medicines and upgrade production facilities to enable quicker penetration of its medicines into foreign markets.

"The setting up of a center for pharmaceutical regulatory science in Taiwan's NCKU, perhaps the first such center in Asia Pacific, mirrors the increasing importance that regulatory science is gaining among the regulatory agencies globally," says William Lee, senior director and head of regulatory strategy of the strategic drug development Asia unit at Quintiles.

Kao adds, "Its establishment is significant because it paves a clearer direction for Taiwan's pharmaceutical and healthcare industry as a whole. Overall, western and local industry players are positive in regard to this new center and believe that NCKU is taking a first step toward improving the pharmaceutical and healthcare landscape in Taiwan. The center, through its project base case studies with school professors, industry physicians, and related experts, aims to open up the communication between regulators and consumers. By its goal for transparent pharmaceutical management, the quality standard in the industry and the accessibility of information would positively improve."

According to Geeta Dhanoa, Frost and Sullivan's associate director of healthcare practice for Asia Pacific, "the preparation of the whitepaper on food and drug policy and nonprescription medicines management policy is the priority for the center, which will serve as a national platform for the government, the academia, and the industry to integrate the resources and talents." However, these initiatives are in the initial stage and the effect will be seen after the formalization of the new drug-pricing policy and reimbursement scheme. Hopefully, they would receive positive response from industry players to eliminate the regulatory hurdles so that drug registration can be improved, and to provide a conducive environment for the market participants to grow, says Dhanoa.

Center benefits

The initiatives are expected to benefit industry players. "It is expected that the approved pharmaceutical products are safer, following safety and ethical norms," Dhanoa explains. The center would also ensure that approvals for products are obtained more quickly or are manufactured in such a way as to decrease potential patient and safety problems.

"In a competitive environment, it is crucial for pharmaceutical products to reach the market in a short span of time. Hence, the regulatory center is expected to explore the shortest route and timeframe to put these products on the market, and support the lifecycle management of the products. This will prove to be advantageous for start-up and local firms in Taiwan," says Dhanoa.

In addition, the approval process for new drug and generic-drug manufacturing and marketing applications would include a review of the manufacturer's compliance with GMP as set by Taiwan's FDA. Based on standard operating procedures and guidelines, the regulatory center would determine whether the firm has the necessary facilities, equipment, and skills to manufacture the new drug for which it has applied for approval. Decisions regarding compliance with regulations are likely to be based on inspection of the facilities and sample analyses, which are expected to affect foreign firms entering the market.

The impact of the center's establishment can be viewed from both short- and long-term perspectives according to Lee. From a short-term perspective, one can expect an increase in cooperation and communication in academic research on pharmaceutical regulation that would promote collaboration between local regulatory agencies as well as foreign regulatory agencies and academic institutions. Such exchanges could result in a convergence of approaches to pharmaceutical regulations. Additionally, the Taiwan pharmaceutical industry could potentially see a shift in regulatory agencies taking a more science-based approach to the assessment of safety, efficacy, quality, and performance of regulated products.

Looking forward, this development may well position the Taiwanese regulatory agency as a forward-looking agency, particularly in North Asia. "As a platform to promote regulatory science within the pharmaceutical industry, the center would show the local region as well as the surrounding regions its aim to improve the overall efficiency of the industry. The movement would promote regulatory science through local and regional collaboration," Kao says.

—Jane Wan is a freelance writer based in Singapore.