International cooperation
Cross-Strait Communication and Cooperation
The Straits Exchange Foundation (SEF) and the Association for Relations Across the Taiwan Straits (ARATS) signed the “ “Cross-strait Cooperation Agreement on Medicine and Public Health Affairs” on December 21, 2010. Since this agreement became officially effective on June 26, 2011, the CDE has been actively assisting the TFDA in handling cross-strait pharmaceutical affairs based on the work plan made by the Cross-strait Drug Safety Management and R&D Working Group.
  • Promotion of cross-strait drug safety management and R&D affairs
    The CDE helps organize the Working Group meetings and subgroup meetings on drugs & cosmetics, medical devices, health food, inspection and testing, as well as assists in planning and holding various cross-strait seminars on drug-related issues. The CDE also assists TFDA to carry out the “Cross-strait Drugs R&D Cooperation Pilot Project” based on Articles 13-14 of Chapter 3 of the “Cross-strait Cooperation Agreement on Medicine and Public Health Affairs”, and guides drug companies through the preparation of documents in compliance with international requirements and cross-strait regulations.
  • Technical review experience exchange and regulatory harmonization
    The CDE assists the TFDA with cooperation projects and do GCP (Good Clinical Practice) inspection on clinical trials ran in mainland China. The CDE aims to promote the cross-strait drug review regulations harmonized with international standards. This objective is to be achieved through seminars and workshops on international standards of medical products, e.g. ICH, GHTF (now IMDRF) and exchange programs for technical dossier reviewers.
  • Mainland China regulatory consultation services
    The CDE assists the TFDA in collecting and comparing cross-strait pharmaceutical regulations. Such regulatory information is regularly updated on an information platform created and maintained by the CDE. With the view to helping Taiwanese companies enter the market in China, the CDE provides professional services, including briefings of the regulatory system and the industrial environment in China, regulatory consultation services, guidance on the requirements imposed by the Chinese authorities of pre-market review, manufacturing management, post-marketing surveillance, technical standards, etc.
Cross-strait Cooperation Agreement on Medicine and Public Health Affairs