Amendment of The Key Points of Breakthrough Therapy Designation

The Key Points of Breakthrough Therapy Designation was established by the Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare to improve access to medicines for people and expedite the review of drugs that are intended to treat a serious condition or rare disease in Taiwan, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). The TFDA provides interactive communications with the sponsor regarding the clinical trials and new drug applications (NDAs) after designation. An applicant can apply for the Module-Based Rolling Review to the Center for Drug Evaluation (CDE) before submission of NDA or alteration of drug permit license.
 
Qualifying criteria: All of the criteria shall be met.

1. The term “new chemical entity (NCE)” defined in the Pharmaceutical Affairs Act, or an approved drug with the claimed indication is intended to treat a serious condition or rare disease in Taiwan. 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. Preliminary clinical evidence indicates substantial improvement over available therapies on one or more clinically significant endpoints. Substantial improvement refers to a drug which may demonstrate in effectiveness or safety over available therapies with similar efficacy, or delay or inhibit disease progression while available therapies can only improve symptoms. Clinical endpoint refers to:
   1. An effect on an established surrogate endpoint.
   2. An effect on a surrogate endpoint or intermediate clinical endpoint considered reasonably likely to predict a clinical benefit.
   3. A significantly improved safety profile compared to available therapy, with evidence of similar efficacy.
3. An applicant has conducted at least a clinical trial in Taiwan, especially clinical trials in the early phase.

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