Taiwan Food and Drug Administration (TFDA)

taiwan drug market, taiwan pharmaceutical market

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History and Overview

The Taiwan Food and Drug Administration (TFDA) was established on January 1, 2010. The establishment of the TFDA followed the enactment of the TFDA Organization Act on June 3, 2009, which consolidated the Bureau of Food Safety, the Bureau of Pharmaceutical Affairs, the Bureau of Food and Drug Analysis, and the Bureau of Controlled Drugs.

In July 2013, the Taiwan Food and Drug Administration (TFDA) became a part of the newly instituted Ministry of Health and Welfare thanks to the implementation of the Organic Act of the Ministry of Health and Welfare.

The Taiwan FDA’s mission includes establishing an internationalized regulatory framework for drugs, medical devices, food, and cosmetics, implementing integrated risk management programs, enhancing information transparency, streamlining the review processes for the pharmaceutical and medical device industries, and promoting information exchange and international collaboration for improved regulatory practices.

TFDA Drug Registration

The registration process for new pharmaceuticals in Taiwan includes a comprehensive assessment of the raw materials quality, manufacturing protocols, toxicology, animal, and pharmacological data validation, confirmation of the intended drug mechanism, and finally the potential for adverse reactions. Furthermore, animal and human clinical trial findings are also scrutinized. It is common for international drug companies to utilize offshore clinical trial data to register their drugs in Taiwan.

In the case of generic drugs, the registration approval procedure prioritizes equivalence in quality to the reference listed drug.

The TFDA has established several expedited review pathways to accelerate the evaluation of specific types of new drugs. The first, abbreviated review, is for new chemical entity (NCE) drugs approved by certain international agencies with no ethnic differences; it shortens the review timeframe, focusing on CMC, clinical, and PK/PD submission documents. Priority review, the second pathway, applies when the drug is intended to treat a serious condition and meets certain criteria; it shortens the review time while maintaining the standard drug evaluation. The third accelerated approval is for drugs addressing unmet medical needs, and there are also difficulties in manufacturing or importing these drugs. Breakthrough therapy, the fourth pathway, is for a New Chemical Entity (NCE) or an approved drug in key markets showing a significant improvement over currently available therapies. Finally, the pediatric and rare severe disease priority review voucher program is applicable to drugs targeting serious conditions with limited prevalence.

Taiwan FDA Medical Device Registration

The regulation of medical devices in Taiwan falls under the purview of the Regulations for Governing the Management of Medical Device, established within the Pharmaceutical Affairs Act and overseen by the TFDA. However, recognizing the unique attributes of medical devices, a distinct regulatory framework, the Medical Devices Act, was introduced in May 2021. Key aspects of the new regulation include a phased implementation of Unique Device Identification (UDI) for different device classes, simplified listing for low-risk Class I devices, and the introduction of Good Distribution Practice (GDP) requirements for manufacturers, distributors, importers, and license holders, with an anticipated two-year grace period for compliance.

Currently, medical devices are categorized into three risk-based classes: Class I (low risk), Class II (medium risk), and Class III (high risk). The new Act extends this classification system, transitioning certain Class I devices to an electronic listing process and requiring applicants to annually report devices through a declaration system.

Additionally, the Medical Devices Act identifies medical device manufacturers based on manufacturing stages. Legal entities responsible for the device design and market placement under their brand names are now classified as manufacturers, mandated to establish tracking mechanisms for medical devices and adhere to good distribution practices.

Generally, for both medical devices and drugs, the Taiwan TFDA closely follows the regulations and policies of the US FDA.

Contact us today for a free consultation with a Taiwan regulatory affairs consultant to discuss your specific needs.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.