International cooperation
Major Achievements
  • Milestone
  • 2015

    • Establishment of the Cross-strait Pharmaceutical Cooperation Promotion Office
      Article 4 of the “Cross-strait Cooperation Agreement on Medicine and Public Health Affairs” stipulates that the TFDA and the SFDA (changed to the CFDA in 2013) shall jointly establish the “Cross-strait Drug Safety Management and R&D Working Group” as a communication platform for explicit discussions of relevant work plans and proposals. Hence, the TFDA established the “Cross-strait Affairs Office” as a contact window of the Working Group to help promote cross-strait pharmaceutical cooperation.
      As the cross-strait communication is increasing, the CDE established the Cross-strait Pharmaceutical Cooperation Promotion Office on August 15, 2012. Under the leadership of the CEO of the CDE, the Promotion Office sets out to collect information and comments from the industries of pharmaceuticals, medical devices, cosmetics and health foods, compare cross-strait regulations and R&D environments, and assist in promoting cross-strait affairs and communication with the industry. The Office was officially opened on September 20, 2012, and has become indispensable to the TFDA with an important role in bridging the industry and the government agencies.
    • Provision of internet based consultation services on pharmaceutical regulations in China
      In June 2012, the CDE established a platform, as commissioned by the TFDA, for providing consultation services on medical products regulations implemented in China. This platform aims to help companies in Taiwan to understand the regulations and requirements imposed by the Chinese authorities concerning pre-market review, clinical trial, port inspection, post-market surveillance and ADR reporting, etc. The contents available on the platform include import management, registration, import approval, import inspection and testing standards. The information is sorted according to industries (pharmaceutical, medical device, cosmetics and health food). The platform also provides online regulatory consultation service for stakeholders in Taiwan. From April 2013, a list of hospitals eligible for cross-strait cooperative clinical trials is available on the platform for reference.
    • Promotion of R&D cooperation projects on pharmaceuticals
      The formation of “Cross-strait Drug R&D Cooperation Project Promotion Group” was proposed by the authorities of Taiwan and China on April 25, 2012, pursuant to the work plan made by the Cross-strait Drug Safety Management and R&D Working Group. This Promotion Group aims to meet the market demand across the Strait, solve cross-strait health issues (e.g. community-acquired pneumonia, hepatitis, breast cancer, vaccines, etc.) and promote joint venture in new drug R&D. Furthermore, it embarks on cooperation projects in clinical trials in order to implement Articles 13-14 of Chapter 3 of the Cross-strait Cooperation Agreement on Medicine and Public Health Affairs. The authority in Taiwan announced the rules of the “Cross-strait Drugs R&D Cooperation Pilot Project” on May 8, 2012, calling for applications of pilot projects. The selection procedure ended in September 2012, and 25 projects were selected. The CDE helped potential candidates prepare documents in compliance with international standards and cross-strait regulations for submission.
    • Close communication with the CDE and the CDME of the CFDA in China under the confidentiality agreement
      Since the “Cross-strait Cooperation Agreement on Medicine and Public Health Affairs” was signed, the activities between the CDEs in Taiwan and China have increased. Both sides are keen to exchange the experiences in technical review. With the view to promoting the harmonization of technical review standards, both sides agreed to study certain drugs that they both had review experiences with so as to improve the understanding of each other’s review standards and logics. A confidentiality agreement was signed on November 27, 2012 by the CDEs in Taiwan and China to properly protect the legal rights and trade secrets of drug applicants. With this agreement in place, the exchange of experiences in technical dossier review can be further extended to specific technical regulations.
      Activities of exchanging technical review experiences were launched across the Strait. On November 28, 2012, the CDEs of both sides met in Taipei to exchange experiences and comments on the “ICH guidelines on the implementation of CMC/statistics/GCP”. In the meeting, both sides compared the practices of technical reviews on biostatistics, clinical trial data management and the implementation of ICH CMC standards and explored different approaches of cooperative reviews. On May 13, 2013, the meeting of the “cross-strait drug technical review platform” was convened in Beijing to verify the R&D cooperation projects filed with the authorities in Taiwan and China simultaneously. This meeting not only launched the cross-strait cooperative review but also addressed specific topics (e.g. the promotion of ICH guidelines). Also, on July 5, 2013, the first cooperative review video conference on the “cross-strait drug technical review platform” was held to discuss specific topics on technical review, such as CMC, toxicology/ pharmacology and pharmacokinetics, starting a new page of the Taiwan-China drug cooperative review.

    • The healthcare policy and governance programme study group of Singapore’s healthcare leadership college visited CDE on November 25, 2015
      On November 25, CDE accepted study group visit leading by Mr. Chan Beng Seng, Director of Sector Development & Commissioning and Director of Healthcare Finance (Resourcing) in the Ministry of Health, Singapore. They came to Taiwan for learning more about innovations, leading practices and good healthcare areas within other healthcare systems. CDE is one of their stops to learn about the Health Technology Assessment (HTA) framework in Taiwan, the development of HTA in Taiwan, the role of HTA in National Health Insurance system. The meeting began with a warm welcome remark by Dr. Churn-Shiouh Gau, executive director of CDE. Both side presented a short introduction of HTA framework in Taiwan and Singapore, respectively. In addition to topic on Taiwan HTA framework, Singapore raised topics on the workload of CDE HTA staffs and the composition of PBRS meeting. Dr. Gau and our two senior HTA colleagues, Dr. Jung-Chun Wang and Ms. Wen-Wen Yang, have further address these topics and shared their experience in cooperation with NHIA. During the meeting, both sides had a better understanding of each other. This meeting was mutually beneficial for both sides to further promote HTA among Asia.
       
    • Thailand Center of Excellence for Life Sciences visited CDE on July 22, 2015
      On July 22, CDE accepted visiting by Dr. Nares Damrongchai, CEO of Thailand Center of Excellence for Life Sciences (TCELS), and other staff members from TCELS and King Mongkut's University of Technology Thonburi. They came to Taipei for 2015 BioTaiwan exhibition held in Taipei and then visited CDE to discuss the new drug review framework and regulations in Taiwan, as the future development direction of TCELS. The meeting began with self-introduction from both sides, followed with a short presentation by CDE about the CDE history and the cooperation framework of CDE and TFDA. In addition to topic on Taiwan review system of medical products, Thailand raised topics on the regulatory power of CDE and professional training. These topics were thoroughly discussed and the CDE also shared the experience in promoting new drug development through regulatory consultations. During the meeting, both sides had a better understanding of each other. This meeting was mutually beneficial for both sides to further promote international cooperation among Asia.
       
    • 51th Drug Information Association annual meeting (June 13 to 19)
      Drug Information Association 51st Annual Meeting took place at Washington, DC in 14-18 June 2015. The meeting brought together more than 7,000 experts from industry, government, academia, research community around the world. More than 30 Taiwan representatives from the Ministry of Health and Welfare, Taiwan Food and Drug Administration (TFDA), Center for Drug Evaluation (CDE), National Research Program for Biopharmaceuticals (NRPB) office, the major medical center clinical trial centers, pharmaceutical experts also participated this meeting. The CDE set up a booth with "Healthy Taiwan, Better Regulation, Better Life" slogan promoting the good regulatory environment in Taiwan as well as clinical trials centers of excellence. The exhibition personnel enthusiastically explained the regulatory framework of medical product review and the advantages of the implementation and effectiveness of clinical trials Taiwan in order to attract international investment and global clinical trial conducting in Taiwan. During the exhibition period, we scheduled bilateral meeting with EMA and PMDA respectively, to exchange of ideas and pharmaceutical regulatory experience, as well as the future direction of cooperation. In addition to the exhibition, CDE also organized the "Taiwan Night Dinner Party for Regulatory Scientists", hosted by Dr. Ming-Kung Yeh(MOHW), Ms. Ling-Lin Liu(TFDA) and Dr. Churn-Shiouh Gau(CDE), inviting international regulatory scientists and experts from industry, government sector, academia, research community as well as DIA broad members. Ms.Anne Hung, Deputy Representative of TECRO also attended and delivered an open remark.
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    • Thai FDA visited CDE on Feb. 6, 2015
      On Feb.6, CDE accepted visiting by Ms. Sukanya Jiarapong, Acting Director of Bureau of Drug Control, FDA Thailand, and other 6 staff members from Faculty of Pharmaceutical Sciences, Chulalongkorn University, National Science Technology and Innovation Policy Office (STI). They came to Taipei for the 8th Asia Regulatory Conference (ARC) held in Taipei and then visited CDE to discuss the new drug review system and regulations in Taiwan and Thailand. Representatives from the Division of Medicinal Products and Division of Planning and Research Development of TFDA also join the discussion. During the meeting, the CDE presented the Taiwan new drug review mechanism to the Thai FDA and the Faculty of Pharmaceutical Sciences, Chulalongkorn University,, and fully communicated with the Thailand delegates the drug review regulations, process, capacity and achievement in both countries, which is helpful for a better understanding of the two countries’ drug review system and for promoting a concreted cooperation between Taiwan and Thailand in the future.