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Lunch with TFDA Director-General

The ECCT's Retail & Distribution, Pharmaceutical, Cosmetics and Healthcare Enhancement committees jointly hosted a lunch with Dr Wu Shou-mei, Director-General, Food & Drug Administration (FDA), under the Ministry of Health & Welfare (MOHW). At the event Director-General (DG) Wu outlined the Taiwan FDA's vision and future policy direction towards reaching its objective of establishing an internationalized regulatory system for food, dugs, medical devices and cosmetics.

DG Wu began her presentation with an overview of the organization of FDA, after which she outlined some of the FDA's policies covering food, medicinal products, medical devices and cosmetics.
In terms of food safety management, there are five points of focus: to strengthen source control management, re-establish the food production-management system, strengthen government market inspection capabilities, increase liabilities for producers and vendors and encourage and create oversight platforms.

In terms of strengthening source control management, the FDA is working to harmonise domestic pesticide assessment criteria with international standards, stop the use of (or impose stricter standards on) toxic pesticides and extend the range of regulations for systematic inspections of foreign food facilities for imported food. The FDA is using big data analysis to analyse 88 food items in four classes using cloud technologies. The results are provided for policy research purposes or adjustment of border control measures.

In terms of food production-management, 22 categories of food businesses are required to establish traceability systems, while 17 categories of businesses are allowed to self-test their raw materials and products and enact their own monitoring plans.

There are many measures and instruments in place to strengthen government inspection capabilities, which have led to improvements. According to statistics provided by the speaker, the compliance rate for imported food improved from 95.8% in 2015 to 98.1% in 2016 while the compliance rate for domestically-produced food rose from 95.4% to 96% over the same period.

As a deterrent, penalties for violations have also been increased under Article 44 of the Act Governing Food Safety and Sanitation. DG Wu mentioned two companies that have been subject to stiff fines for altering date labels and selling expired food products.

To encourage and create oversight platforms, a dedicated hotline (with the number 1919) has been set up by four ministries to allow the public to report food safety concerns. 83,000 calls have been received and reports from private citizens have led to the exposure of nine major food safety violations.

In terms of medicinal products, the FDA's mission is to assure the quality, safety and efficacy of medicinal products, facilitate the development of innovative medicine and speed up drug accessibility. New acts pending are the Cellular and Gene Therapy Products Act and the Medical Devices Act. On the regulation of cell therapy products, the FDA began consultations in August 2011 and has so far issued guidance on donor eligibility determination (in 2015), investigational cell therapy products (in 2017) and good tissue practices (in 2013). However, DG Wu said that this does not go far enough which is why the FDA is working on drafting an act and collecting opinions in this regard. FDA officials are also working to enhance review efficiency of clinical trial applications.

An amendment to the Pharmaceutical Affairs Act has been drafted which is aimed at responding to advances in medical technology, bringing Taiwan's pharmaceutical regulatory system in line with international trends and in line with the development of the domestic pharmaceutical industry and to improve the current drug management system. The act passed the first reading in Taiwan's Legislative Yuan in October 2017.
The development of emerging biotech products is a key consideration of the act. In addition, it covers all new drug types and takes into account, as far as possible, future R&D and technological progress.

The new Act for the Management of Medical Devices aims to streamline the process and management of medical devices. Among other items, the new act will implement a more sophisticated classification system for medical devices, strengthen the management of medical device manufacturers, internationalise the quality management systems of medical devices and formulate regulations for clinical trials.

In terms of the future direction of medical device regulations, the FDA aims to enhance Good Manufacturing Practice (GMP), optimise the pre-market registration review process, enhance post-market regulation and border control, enhance the regulation of distribution and distributor inspections and promote international regulatory harmonisation, among others.

Moving on to cosmetics, DG Wu noted that the draft Statute for Control of Cosmetic Hygiene was submitted to the Legislative Yuan in September 2016. The emphasis of the act is on self-regulation. In this regard, the act proposes the abolition of pre-market approval of specific purpose cosmetics and colorants in favour of product notifications, the use of product information files (PIF) and GMP as well as higher fines for violations.