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【Clinical】What are the points for consideration when reviewing new drug application (NDA) from efficacy aspect?

刊登日期:2019-11-11  |  點閱次數 : 402 次 

Please reference to「新成份新藥查驗登記療效及安全性之考量重點」
Web site: https://www.fda.gov.tw/tc/siteContent.aspx?sid=9342


  1. Data that support clinical efficacy:
    1. a. Clinical study reports of each phase with their study objectives and full results.
    2. b. The design of pivotal trial (randomization, blinding, choice of control, efficacy endpoints) should meet scientific requirements.
    3. c. The diagnoses and disease severity of the selected subjects should be in concordance with or represent the target population.
    4. d. Study treatment should be consistent with the dosage and administration proposed on the package insert. Adequate study duration is also required.
    5. e. Evaluate the result of primary efficacy endpoint, and justify the effect size (magnitude) is clinically meaningful.
    6. f. Results of secondary endpoints.
  2. The efficacy profile includes the time to onset, time to maximum effect, therapeutic duration, tolerance occurred with repeated use, the change of efficacy after drug discontinued (e.g., whether blood pressure rebounds after stopping antihypertensive drug).
  3. Dosage and administration. If the dose is to be adjusted according to disease severity, it should be supported by a dose response relationship. Minimum effective dose, scheme for dose adjustment (e.g., amount to increase, interval to adjust), maximum recommended dose, and maintenance dose should all be specified. If certain clinical benefits are claimed, the data robustness will be justified with a thorough evaluation.

 

(中文版)


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