International cooperation
International Participation
One of the priorities of the pharmaceutical policy in Taiwan is to work with advanced countries to promote cooperation and regulatory harmonization. Through actively participating in events organized by international organizations and regulatory agencies, the CDE aims to effectively reduce the time and resources spent on duplicate clinical trials, assessments and site inspections by following scientifically-based risk management principles. The result will contribute to the accessibility for patients to safe, effective and quality drugs, as well as better protection of their medication rights and wellbeing.

Since its establishment, the CDE has been diligently assisting the government in promoting international exchange and cooperation activities. The achievements include:

  • DIA (Drug Information Association)
    • Over the past years, the CDE has actively participated in many DIA events. Every year, the CDE joined delegations of the government agencies, healthcare providers, research institutions and drug companies to attend the DIA annual meeting and set up booths to exhibit Taiwan’s competitive edge in clinical trials, bio-pharmaceutical industry and regulatory environment. The CDE hopes the interaction with international biopharmaceutical companies can attract international companies and CROs to conduct multi-national clinical trials and invest in new drug R&D in Taiwan. Inward investment will increase the competitiveness of the biopharmaceutical industry in Taiwan, thereby boosting the development of other related industries.
    • Promoting the communication in regulatory science: During the DIA Annual Meeting, the CDE organized informal bilateral meetings with US FDA, EU EMA, Japan PMDA, Health Canada, etc. to exchange experiences in regulatory development and pharmaceutical affairs. The CDE also hosted the “Taiwan Night”, an informal event to cement the friendship with foreign regulatory agencies, local biopharmaceutical companies and Taiwan expatriates in the industry.
  • APEC (Asia-Pacific Economic Cooperation)
    Over the past years, the CDE has actively assisted the TFDA in organizing the annual workshops of Asia-Pacific Economic Cooperation (APEC) in drug/ medical device regulatory harmonization and the Good Review Practice (GRP). The achievements include:
    • Inviting delegates from the APEC LSIF Regulatory Harmonization Steering Committee and foreign regulatory agencies to attend the workshops to promote regulatory harmonization;
    • Starting a dialogue regarding the cooperation in the Good Review Practice (GRP) for drugs and medical devices;
    • Promoting the communication and exchange of experiences of Good Review Practice (GRP) with APEC members;
    • Participating in the APEC LSIF-RHSC (APEC Life Sciences Innovation Forum Regulatory Harmonization Steering Committee) and making a presentation in the 2012 Annual Meeting to report the progress of the GRP plan led by Taiwan and to brief on the Concept Note of two new projects to demonstrate Taiwan’s commitment to promoting regional regulatory harmonization.
  • ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)
    • The CDE has committed itself to closely monitoring the evolution of the ICH regulations in order to assist the competent authorities in following the international trend and bringing the pharmaceutical regulations in Taiwan in line with international standards.
    • The CDE dispatched senior reviewers to participate in the ICH Expert Working Group. The reviewers delivered the comments made by experts in Taiwan in discussions of ICH-related regulations.
  • Taiwan-Japan Cooperation in Pharmaceutical Regulations
    • The “Taiwan-Japan Cooperation Agreement on Pharmaceutical Regulations” was signed on November 5, 2013 by the MOHW, the Association of East Asian Relations, the MHLW (Ministry of Health, Labor and Welfare) of Japan and the Interchange Association Japan. This agreement is a response to the globalization of the industry, and aims to expand the multifarious cooperation in bilateral pharmaceutical regulations between Taiwan and Japan. The CDE assisted the TFDA in preparing for the discussions of cooperation-related issues, collecting the industry’s comments and making campaign strategies.
  • HTAsiaLink Conference
    • The CDE attended the 2nd conference of the 2013 HTAsiaLink, made four oral reports and campaigned for hosting the 2015 HTAsiaLink conference.
  • HTAi (Health Technology Assessment international) Annual Meeting and INAHTA (International Network of Agencies for Health Technology Assessment) Annual Meeting
    • The CDE participated in the 10th HTAi Annual Meeting and the 2013 Annual Meeting of the INAHTA (International Network of Agencies for Health Technology Assessment). In the conference, a policy forum was piloted in Asia with participants of HTA agencies and decision-makers in Taiwan, South Korea, Japan, China, etc.
  • AHWP (Asian Harmonization Working Party)
    • The CDE has been active in the AHWP meetings with a view to learning the experiences in regulating medical devices from other countries. This information is valuable for the TFDA when making or amending related regulations. Senior staff of the CDE has been involved in the AHWP Working Group to promote the harmonization of medical device regulations.
  • Visiting and receiving training in leading agencies abroad
    • The CDE sent reviewers to the TÜV Rheinland in Germany to attend a short-term training course about the safety of medical devices and the review of technical dossiers on effectiveness.
    • The CDE dispatched senior reviewers and reviewers to the PMDA (Pharmaceuticals and Medical Devices Agency) in Japan for a short-term training on regulations of vaccines and biosimilars.
    • Members of the CDE Inspection Team attended the 2013 EU Inspectors Working Group Workshop discussing how to build and plan a risk-based inspection mechanism.
    • The CDE accompanied the TFDA officials to attend the 2013 APEC RHSC in order to understand the latest global trend in the Good Review Practice and the management of combination products.
  • The CDE has been active in campaigning for hosting large-scale international conferences and seminars so as to forge a cooperative relationship between the Taiwanese regulatory authorities and their international counterparts. The recent events organized/co-organized by the CDE include:
    • Co-organizer of the 2013 International Pharmaceutical Federation (FIP) Special Interest Groups (SIG) Regulatory Science Workshop: Harmonization of Bridging Studies among Asia-Pacific Region
    • Co-organizer of the 2013 APEC HWG Symposium: Establishing a Regional Infrastructure to Facilitate the Accessibility of Orphan Drugs
    • Organizer of the 2013 International Symposium of Regulatory Science on Nanotechnology-Derived Drugs and Medical Devices
    • Organizer of the 2013 International Workshop on Medical Device GCP Inspection
    • Organizer of the 2013 International Symposium on Regulatory Considerations for Pandemic Influenza Vaccine Research and Development
    • Organizer of the 2013 International Symposium on Health Technology Assessment - HTA’s role in the decision making process