Amendment of The Review Mechanism of Accelerated Approval

The Review Mechanism of Accelerated Approval was established in order to meet unmet medical needs in Taiwan. On the basis of the support of the scientific evidence, shortening drug development timelines can help to bring the certain types of new drugs to the market as early as possible by choosing a surrogate endpoint.
 
Qualifying criteria: The following two criteria shall be met. An applicant should apply for designation in advance. The Taiwan Food and Drug Administration (TFDA) is responsible for evaluating applications for designation. If a drug meets these criteria, it is eligible for directly expediting The Review Mechanism of Accelerated Approval; thus, additional application of The Review Mechanism of Priority Review is not needed. The review time is 240 days. The Review Mechanism of Accelerated Approval is not applicable to the treatments of non-severe symptoms of serious condition.

1. The term “new drugs” defined in Article 7 of the Pharmaceutical Affairs Act.
2. The drug with the claimed indication shall meet one of the following criteria:
   1. A drug is intended to treat a serious condition and address an unmet medical need. Severe diseases worsen as the diseases progress over time if they are untreated, which severely threatens patients’ lives or significantly impacts their long-term activities of daily living. Severe diseases can also refer to other major diseases which are identified after evaluation. Addressing an unmet medical need is defined as having a major medical advance.
   2. A drug is intended to address an unmet medical need and is granted an orphan drug designation in any A10 countries.
   3. A drug is intended to address an unmet medical need; however, it is not an orphan drug in Taiwan and has difficulty in manufacturing or importing.

【Amended date: 2019-11-18】 
【Announcement: MOHW No. 1081410630】 
 
Reference: https://www.fda.gov.tw/TC/siteListContent.aspx?sid=2984&id=32228