Amendment of The Review Mechanism of Priority Review

Regarding drugs which are urgently needed for Taiwanese lives and health, The Review Mechanism of Priority Review was established in order to help those patients access to the certain types of new drugs as early as possible.
 
Qualifying criteria: Two of the following three 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 expediting The Review Mechanism of Priority Review. The review time is 240 days. The Review Mechanism of Priority Review 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 shall meet the following two criteria:

1. A drug is intended to treat a serious condition. 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.
2. A drug is intended to address an unmet medical need with major clinical advance.

3. A drug is intended to address a public health or an unmet medical need which is under priority counseling and grant for research from the government.

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