Pharmaceutical News
Heading south: TFDA’s regulatory management receives international acknowledgement

Taiwan has a sound drug review system.  The TFDA and the US Regulatory Affairs Professionals Society (RAPS) Taiwan Branch jointly established the Center of Excellence (COE) in training of APEC good review & regulatory science.  The COE intends to run the training programs from October 2017.  APEC members included in the government’s “New Southbound Policy” will be invited to attend the training courses of drug review and regulatory harmonization with a view to improving their capability of drug management and to helping Taiwanese manufacturers to head south.

As an APEC member, Taiwan has been actively participating in the APEC Life Science Innovation Forum (LSIF) and involved in the promotion of good review practice and regional regulatory harmonization.  In February, the TFDA was approved by the “LSIF Regulatory Harmonization Steering Committee (RHSC)” to collaborate with the RAPS Taiwan Branch to establish the COE in training of APEC good review & regulatory science.  A memorandum was singed on July 20th.

The TFDA plans to organize the first training course from October 31st to November 2nd, and will invite the pharmaceutical affairs authorities and pharmaceutical associations of APEC members included in the government’s New Southbound Policy to attend the course of drug review and regulatory harmonization.  Huang Cin-Liang of the TFDA expressed that the course will help improve regional regulatory harmonization and review efficiency.  It will also improve those countries’ understanding of the current development of the pharmaceutical industry in Taiwan.

The TFDA also pointed out that the course will help improve other countries’ capability of pharmaceutical management, increase review quality and efficiency, promote regulatory harmonization, expedite drug launches and help the pharmaceutical industry in Taiwan to head south.  Huang Cin-Liang emphasized the benefits of regulatory harmonization.  She said that if the regulations in this region are all aligned, it will help our manufacturers to apply for market authorization in other countries.

The establishment of the COE in training is a TFDA’s achievement in promoting international collaboration.  It also demonstrates the professionalism of the regulatory personnel in Taiwan.

【2017-08-05/Radio Taiwan International】