New Southbound Policy is one of Taiwan’s most important economic and trade strategies, aiming at strengthening the ties between Taiwan and ASEAN members, South Asian countries, Australia and New Zealand, integrating regional supply chain, extending market, and reshaping Taiwan’s trade territory. At present, all pharmaceutical manufacturers in Taiwan have fully complied with PIC/S GMP standards and most of the medical devices meeting the criteria of the EU and the US. Taiwan Food and Drug Administration (TFDA), protecting the safety and quality of medical products and foods for consumers, thus actively facilitates regulation harmonization, exchange of scientific detection technologies, laboratory verification collaboration with southbound countries, to gain their trust in Taiwan’s medical products. By building mutual trust, TFDA hopes to reduce duplicate tests and inspections, simplify review process, and thus shorten the time for products to enter the markets, connecting businesses and eventually promoting medical industry development within the region.

          To reach the goal previously mentioned, TFDA takes actions as follows: actively analyzing the changes of laws and regulations on medical product management in South Asian countries, holding conferences, providing training courses for pharmaceutical regulation harmonization, inviting speakers from ASEAN members to share key updates, encouraging the industry representatives to share experiences in expanding markets southward and the difficulties faced, as well as creating a webpage with information of medical product regulations of southbound countries. Under the practices taken by TFDA, there are some positive outcomes, such as: PIC/S GMP certificates and inspection results issued by TFDA are recognized by fellow members, including Malaysia, Singapore etc.; medical devices obtaining TFDA’s registration licenses apply to simplify review in Indonesia, Viet Nam, Pakistan and Sri Lanka; reports issued by three laboratories in Taiwan are accepted by Indonesian government.

             TFDA will continue to extend connections with officials in southbound countries to further advocate regulation harmonization and facilitate recognition of laboratory reports, hoping to increase Taiwan’s competitiveness, promote medical product sales overseas, and more importantly, play a key role in fighting for the prevention of food adulteration and counterfeits sales within Asia Pacific region.