優先審查審查機制申請

  

優先審查審查機制申請

CDE說明https://www3.cde.org.tw/drugs/med_explain?id=24

CDE英文版說明https://www3.cde.org.tw/eng/drugs/med_explain?id=39

 

expedited programs

 

The NDA standard review

Expedited programs	Review Time	Key Qualifying criteria
Standard Review	360 Days : NCE/ Biological Products 300 Days : Non-NCE with clinical efficacy and safety data 200 Days : Non-NCE without clinical efficacy and safety data
精簡審查 (Abbreviated Review)	Category I :180 days Category II :120 days	2/3 approval (US FDA, EMA, or MHLW/PMDA) 3/3 approval (US FDA, EMA, or MHLW/PMDA) Unconditional approval of BSE waiver
優先審查 (Priority Review)	240 Days	(Two of the criteria shall be met) 1.      New drug 2.      Indication for serious condition and 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
加速核准 (Accelerated Approval)	240 Days	(All of the criteria shall be met) 1.      New drug 2.      1 of 3 (1)       unmet medical need (2)       granted as orphan drug in any A10* countries (3)       difficulties of manufacturing or importing n   surrogate endpoint + confirmatory trials
突破性治療 (Breakthrough Therapy)	240 Days	(All of the criteria shall be met) 1.          treat serious conditions or rare diseases. 2.          Preliminary clinical evidence better than available therapies 3.          clinical trial in Taiwan n   Interactive communications
小兒或少數嚴重疾病(Pediatric and Rare Severe Disease)	240 Days	(All of the criteria shall be met) 1.          New drug 2.          treat a serious condition 3.          mainly prevalent in pediatric population；or the prevalence less than 5/10000 4.          unmet medical need n   Provide stability studies on 3 batches

 

西藥查驗登記審查費收費標準 EN

https://law.moj.gov.tw/LawClass/LawAll.aspx?pcode=L0030107

第 8 條

辦理藥品相關案件函詢者，每件應繳納之審查費如下：

五、優先審查認定、加速核准機制認定、突破性療效認定申請案，新臺幣三萬元。

 

認定時程:

https://www.fda.gov.tw/TC/siteListContent.aspx?sid=2984&id=32228

新藥查驗登記優先審查機制:

由食藥署根據廠商提出之資料進行評估，並於 30 天內函復廠商 認定結果。

 

案件辦理期限公告

https://www.fda.gov.tw/tc/siteContent.aspx?sid=2953

 

補充: 美國FDA https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program

 

Priority review總結:

申請認證(apply for designation)→檢核表+M2.5 (clinical review)+3萬元→30 days review by CDE→approval for designation.→ 240 review

 

 

Total time period: 30+240=270 days (9mo)