The TFDA made an announcement on April 11 about the amendment to Article 4 of the Regulations Governing Drug Samples and Free Drug Gifts. The Regulations were introduced on March 30, 1973, according to Paragraph 2 of Article 55 of the Pharmaceutical Affairs Act and were then revised on December 22, 1983, May 2, 1994 and April 30, 2003. Article 4 regulates the manufacture and importation of drug samples.
With the view to supporting the government’s policies of promoting the biomedical industry and increasing Taiwan’s global competitiveness for clinical trials, the TFDA decided to adopt the risk-based approach about managing the materials and devices intended for clinical trials, and to make the importation of the samples of the supplies of low-risk specimen collection sets intended for clinical trials subject to the streamlined application procedure.
Also, following the MOI’s reform of the residence policy which considers the Alien Resident Certificate (Alien Permanent Resident Certificate) being equivalent to the passport as a valid ID document, the TFDA relaxes the qualification and procedures for the application of imported drug samples needed by foreigners for their own use during their stay in Taiwan. The key points of the revision are:
- The expedited customs clearance procedure is applicable to the importation of the supplies of low-risk specimen collection sets intended for clinical trials. (Paragraph 1 of the revised article)
- The qualification and procedure for the application of imported drug samples needed by foreigners for their own use during their stay in Taiwan are relaxed. (Paragraph 2 of the revised article)