A PARADIGM SHIFT IN DRUG REGULATIONS IN TAIWAN

  • S.K.R Parasiya Department of Quality Assurance & Pharma. Regulatory Affairs, JSS College of Pharmacy, JSS University, S.S Nagar, Mysore-570015, Karnataka, India
  • V Balamuralidhara Department of Quality Assurance & Pharma. Regulatory Affairs, JSS College of Pharmacy, JSS University, S.S Nagar, Mysore-570015, Karnataka, India
  • Pramod T.M. Kumar Department of Quality Assurance & Pharma. Regulatory Affairs, JSS College of Pharmacy, JSS University, S.S Nagar, Mysore-570015, Karnataka, India
  • R Gujarati Department of Quality Assurance & Pharma. Regulatory Affairs, JSS College of Pharmacy, JSS University, S.S Nagar, Mysore-570015, Karnataka, India
  • A Shukla Department of Quality Assurance & Pharma. Regulatory Affairs, JSS College of Pharmacy, JSS University, S.S Nagar, Mysore-570015, Karnataka, India
  • V Kshatri Department of Quality Assurance & Pharma. Regulatory Affairs, JSS College of Pharmacy, JSS University, S.S Nagar, Mysore-

Abstract

Across Asia, a convergence of economic trends, government policies and greater awareness among the general public of healthcare issues has created an environment that is poised for dramatic growth and change. Taiwan, for instance, can be taken as an example. Taiwan has one of Asia's most highly-praised healthcare systems with excellent provision of healthcare and key health outcomes. Nevertheless, the government is facing new pressures for public healthcare reforms as result of a rapidly ageing population and rising healthcare costs. This paper provides an introductory overview of Taiwan’s sudden changes in its Drug regulations due to TFDA (The Taiwan Food and Drug Administration) establishment in 2010, TFDA of the Department of Health (DOH) made an advance announcement about the “amendment draft of the Provisions Governing the Registration and Market Approval of Drugs”, which amends a total of 40 Articles. Without impeding the quality, safety and therapeutic effect of Drugs, most of the amended Articles are about simplification of application procedures and loosening of regulations for Drug registration and market approval. Regulations loosened are imposed on new Drugs, Radioactive Drugs, Allergenic Drugs and Drugs for export that is intended to accelerate the process to sell new Drugs on the market and promote the export of domestically manufactured Drugs. As a result of these changes in regulations many pharmaceutical MNCs and local manufacturers explored their business in Taiwan due to quick approval of their NDAs and gained more flexibility in the local market. To support Taiwan's generic Drug industry, DOH has also decided to take measures to simplify and reduce the ANDA application time.

Keywords: Taiwan; TFDA; DOH; Drug Regulation.

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Author Biographies

S.K.R Parasiya, Department of Quality Assurance & Pharma. Regulatory Affairs, JSS College of Pharmacy, JSS University, S.S Nagar, Mysore-570015, Karnataka, India

Department of Quality Assurance & Pharma. Regulatory Affairs,
JSS College of Pharmacy, JSS University, S.S Nagar, Mysore-570015, Karnataka, India

V Balamuralidhara, Department of Quality Assurance & Pharma. Regulatory Affairs, JSS College of Pharmacy, JSS University, S.S Nagar, Mysore-570015, Karnataka, India

Department of Quality Assurance & Pharma. Regulatory Affairs,
JSS College of Pharmacy, JSS University, S.S Nagar, Mysore-570015, Karnataka, India

Pramod T.M. Kumar, Department of Quality Assurance & Pharma. Regulatory Affairs, JSS College of Pharmacy, JSS University, S.S Nagar, Mysore-570015, Karnataka, India

Department of Quality Assurance & Pharma. Regulatory Affairs,
JSS College of Pharmacy, JSS University, S.S Nagar, Mysore-570015, Karnataka, India

R Gujarati, Department of Quality Assurance & Pharma. Regulatory Affairs, JSS College of Pharmacy, JSS University, S.S Nagar, Mysore-570015, Karnataka, India

Department of Quality Assurance & Pharma. Regulatory Affairs,
JSS College of Pharmacy, JSS University, S.S Nagar, Mysore-570015, Karnataka, India

A Shukla, Department of Quality Assurance & Pharma. Regulatory Affairs, JSS College of Pharmacy, JSS University, S.S Nagar, Mysore-570015, Karnataka, India

Department of Quality Assurance & Pharma. Regulatory Affairs,
JSS College of Pharmacy, JSS University, S.S Nagar, Mysore-570015, Karnataka, India

V Kshatri, Department of Quality Assurance & Pharma. Regulatory Affairs, JSS College of Pharmacy, JSS University, S.S Nagar, Mysore-

Department of Quality Assurance & Pharma. Regulatory Affairs,
JSS College of Pharmacy, JSS University, S.S Nagar, Mysore-

References

Pacific Bridge Medical [Internet]. Bethesda, MD: [publisher unknown];May 13, 2010 [cited 2014 April 21]. Available from:
http://www.pacificbridgemedical.com/regulatory-services/registration/taiwan-drugs/
2. Lin A. Checking up on Taiwan Healthcare [Internet]. Taiwan: PricewaterhouseCoopers; 2012 [updated 2012 June 12; cited 2014 April 25]. Available from:
http://www.pwc.tw/en_TW/tw/industries/publications/assets/healthcare-en.pdf
3. Application for the registration of new Drugs. Taiwan New Economy Newsletter [Internet]. 2009 Oct 12 [cited 2014 May 3]. Available from:http://www.cepd.gov.tw.
4. Taipei. Health and Welfare Ministry of Food and Drug Administration: Simplified application procedures with substitutive regulations. Taipei: Ministry of Food and Drug Administration; 2012.
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How to Cite
Parasiya, S., V. Balamuralidhara, P. T. Kumar, R. Gujarati, A. Shukla, and V. Kshatri. “A PARADIGM SHIFT IN DRUG REGULATIONS IN TAIWAN”. International Journal of Drug Regulatory Affairs, Vol. 2, no. 2, June 2014, pp. 1-4, doi:10.22270/ijdra.v2i2.8.