Page 31 - 2018食藥署年報(英文版)

nd
2. Certifications for “2 tier quality control” and “expansion proposal”

To solve the problem that our nutritional supplement manufacturers are unable to export their
products to Malaysia, the Administration has negotiated with the Malaysian government to provide
nd
the substitutions for the businesses, which with the certifications of the 2 tier quality control and
the expansion proposal, the businesses will receive the approval letter that meets the “Guidelines on
Good Manufacturing Practice for Traditional Medicines and Health Supplements” in Malaysia, and
then the application of inspection may be submitted to NPRA, Malaysia. (Figure 2-8)

Manufacturers Exporting Dietary Supplements

Malaysia Taiwan

Manufactures with the certifications of “2 tier
nd
quality control” and the “expansion proposal” can
Alternatives
apply, via TFDA, for the English version of
approval for reference on exporting to Malaysia
Figure2-8 Assisting the businesses to solve the problem on exporting to Malaysia

Outcomes and Benefits

1. Simplify the application process

By the end of 2017, there had been 496 accepted businesses’ applications, and about 92%
of these applications successfully obtained the certifications. The third-party certification of 2 nd
tier quality control was completed in October 2017, and thus the food export process has been
simplified, and the waiting time and costs of the businesses have been reduced.

29