Report from Taiwan - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Report from Taiwan
The Taiwanese government engages in regulatory science in a move to boost its pharmaceutical sector.


Pharmaceutical Technology
Volume 37, Issue 6, pp. 28-30

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.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: Pharmaceutical Technology,
Click here