台灣大學藥學專業學院

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Meir-Chyun Tzou (鄒玫君)

Current position

Adjunct Assistant Professor, School of Pharmacy, National Defense Medical College, Taiwan (2018.8-)
Consultant, Taiwan Pharmaceutical Quality Research Institute (TPQRI) (2018.2-)
Adjunct Assistant Professor, School of Pharmacy, Taipei Medical University, Taiwan (1999.8-)

Academic degree

Doctor of Philosophy in Pharmaceutics, College of Pharmacy, Ohio State University, USA (1994)
Master of Science in Pharmaceutics, School of Pharmacy, College of Medicine, National Taiwan University, Taiwan (1985)
Bachelor of Science in Pharmacy, School of Pharmacy, College of Medicine, National Taiwan University, Taiwan (1980)

Experience

Senior Researcher, Office of Deputy Director General, Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare (MOHW) (2014.2-2017.12)
Senior Researcher & Acting Chief Secretary, Office of Deputy Director General, TFDA/MOHW (2015.12-2016.1)
Director, Division of Medicinal Products, TFDA/MOHW (2013.7-2014.1)
Director, Division of Drugs and New Biotechnology Products, TFDA/Department of Health (DOH) (2010.1-2013.7)
Director, Division of Pharmaceutical Chemistry, Bureau of Food and Drug Analysis (BFDA) (Named “NLFD’’ before 2003), Department of Health (DOH) (2008-2009)
Director & Acting Director, Division of Pharmaceutical Chemistry & Center for Development of Science and Technology, BFDA/DOH (2003-2007)
Senior Officer, Bureau of Pharmaceutical Affairs (BOPA), DOH (2001-2003)
Section Director, BOPA, DOH (1995-2001)
Specialist, Division of Pharmaceutical Chemistry, National Laboratories of Foods and Drugs (NLFD), DOH (1981-1995)
Specialist, U-Liang Pharmaceutical Co., Ltd, Taiwan (1980)

Major Accomplishments in TFDA

Lead in the TFDA regulatory reform for NDA/ANDA (2010-2013)

Regulation of bridging study evaluation based on ICH E5, early phase clinical trial, relaxation of Certificate of Pharmaceutical Product (CPP) requirement, implementation of ICH guidance and Risk Evaluation and Mitigation Strategy (REMS) /Risk Management Plan (RMP) program.
Regulation of Drug Master File (DMF) for Active Pharmaceutical Ingredient (API) and the Chemistry, Manufacturing, and Controls (CMC) for generic drugs.
Establishment of CDE/TFDA integrated Medicinal Product Review Office (iMPRO), streamlining review and consultation mechanism, improving review quality and efficiency.
Establishment of multiple review tracks for NDA (priority review, fast track, abbreviated review, accelerated approval, etc.) for unmet medical needs.
Facilitating the enhancement of infrastructure of conducting clinical trials for new drugs in Taiwan, including GCRC, CE, and c-IRB.
Lead in drafting and implementing major TFDA guidance documents, including ICH guidance, guidance on biosimilar drugs, botanical drugs and cell therapy products.

TFDA representative and Lead in the assignment of the Arrangement between Taiwan and Japan for the Establishment of the Framework of the Cooperation of the Medical Products Regulation (2013)
TFDA representative and Lead in the assignment of the Cross-Strait Cooperation Agreement on Medicine and Public Health Affairs-Medical products (2011)
Established overseas GMP inspection program for medicinal products in BOPA/DOH (2002-2003)

TFDA Regulatory Experiences

Managing the Biotechnology Industrial Promotion Program (announced by Executive Yuan) in TFDA/MOHW (2010-2017)
Associate editor of JFDA (Journal of Food and Drug Analysis, official journal of TFDA), contributing to the strategy of upgrading impact factor (from 0.3, 2014 to 3.0, 2017) (2014-2017)
Lead in in the edition/revision of Chinese Pharmacopoeia (2010-2013)
Lead in the membership application of PIC/S and reform of GMP inspectorate in BFDA/DOH (2003-2007)
Managing quality surveillance program and contract lab accreditation program for medical products in BFDA/DOH (2004-2005)
Lead in the reform of cGMP guidance and managing the inspection program in BOPA/DOH (1995-2000)
Managing ICH based GCP guidance and inspection program in BOPA/DOH (1997)

Presentations and Other Activities:

Managing activities in “Cross-Strait Cooperation Agreement on Medicine and Public Health Affairs-Medical products”, including cooperation in the review of new drug, conducting clinical trials and GCP inspections (2011-2013)
Managing activities in “the Arrangement between Taiwan and Japan for the Establishment of the Framework of the Cooperation of the Medical Products Regulation”, including cooperation in the review of new drug, conducting clinical trials and GCP/BE inspections (2011-2013)
TFDA representative in ICH-GCG, IPRF, APEC-LSIF, IGDRP, DIA international meeting/symposium/workshops.
Hosted 2013 FIP SIG Regulatory Science Workshop- Harmonization of Bridging Studies among Asia-Pacific Region.
Hosted 2013 International Symposium on Regulatory Considerations for Pandemic Influenza Vaccine Research and Development.
Hosted 2013 International Symposium on APEC Rare Disease and Orphan Products.
Hosted International Symposium on APEC Network of Pharmaceutical Regulatory Science-APEC Joint Research Project on Bridging Study (2000-2004)
Tzou MC: Ethnic factors and the E5 Guideline: What has been learned about ethnic differences? The Chinese Taipei Experience. 2009 Emerging Markets: Acceptability of data generated from foreign clinical trials and ethnic factors in drug Development. Workshop Report, 2009: 19-20
Huang WI, Huang WT, Chen WW, Huang YW, Tzou MC, Gau CS: Review of Bell’s Palsy Reports following 2009 H1N1 Vaccination in Taiwan., 2010 Federation Association of Pharmaceutical Affairs, Taipei, Taiwan (poster) (2009.11-2010.2)
Wang CY, Tzou MC, Kang JJ, Hsiao CL, Huang JD: Exploring the Ethnic Sensitive Disposition Pathway from Bridging Evaluation: A 10-year Experience Report from Taiwan, 2011 DIA annual meeting, U.S.A. (poster) (2011.6)
Huang YW, Yang PW, Tai HY, Gau CS, Hsu CW, Tzou MC, Lee HS, Kang JJ: Risk Management Strategies mitigating Potential Severe Dermatologic Risks of Carbamazepine in Taiwan, 2011 International Conference on Pharmacoepidemiology & Therapeutic Risk Management, Chicago, Illinois, U.S.A (oral presentation) (2011.8)

Research area

Management and Regulation on Medical products
Pharmacy Administration and Management
Pharmacokinetics/Biopharmaceutics
Pharmaceutical Analysis