TFDA ????????????

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TFDA ???????
?????????? ??? ??
2010.10.19 ??????
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• ??
• ????????????
• ???????????
• ???????????
• ????????
• ???????????
• ??/????

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• ?????????????,??????
• ??????????????,?????????
• ???????????,???????????

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????????????? ?????
-
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?????????????
Post-Market Management
Pre-Market Approval
Research Discovery
Preclinical Testing
NDA
Market
IND
GPvP
GLP
IRB/GCP
ADR Reporting
Quality
ADR/SUSAR ? Reporting
Drug Injury Relief
Insurance
GTP
cGMP
?ADR/SUSAR adverse drug reaction/suspected
unexpected serious adverse reactions
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??????????

• 1982 ???????? (GMP)
• 1983 ????????(PV,PMS)
• ???????????????(BA/BE)
• 1993 ??????
• ?????????? (GCP)
• 1998 ?????????????(GLP)
• 1998 ????????????(ADR)
• 2000 ??????????????(bridging study)
• ?????(data exclusivity)
• ?????????? Good Pharmacovigilance Practice
  (GPvP)
• ??????????-????????????
• ???????? (Drug Master File)
• ??PIC/S GMP
• 2010 ????????????
• 2010 ?????????????????????(???)
• ??????tNCE????????????(???)
• 2010 ????CPP??(???)

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Milestones on Drug Regulation
1980
2000
2010
1990
1982 GMP
1999 cGMP
2010 PIC/S GMP
2009 DMF
1987 BA/BE
1993 Local clinical trial
2000 Bridging Study Evaluation in accordance
with ICH E5
2001 Pivotal trial/ early phase trial
1998 GLP
1996 GCP
2010 TFDA
1998 CDE
2001 TDRF
1983 PV/PMS
1998 ADR
2008 GPvP
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????????????

1. ???????????
2. ???????????
3. ????????
4. ???????????

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??????????????

• ??1??????
• ??2???????????
• ??3????????????
• ??4?????????

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??1??????

• ??TFDA?????CDE??????????,????????
• 99?1?1??,??????????,??????????
  (TFDACDE????)?????
• 99?4???CDE??????TFDA ,?????????????

TFDA Taiwan Food and Drug Administration,
??????? CDE Center for Drug Evaluation,
???????????
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??2???????????

• ???????????????
• ??TFDA?????????,???????
• ?????????,???????????
• ???????TFDA????????????????,??????

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??3????????????

• ???????QA/QC??,?????????????????????,???????????
• ????????????
• ?????????????,????????????
• 99?8?10???????????????????????????,???????????????
  ?????????,?????????????
• ??????????,????????approval letter?????????????,??
  ??approval letter????????(???99.09.30??????????)

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??4-.?????????????
????
TFDA??
GMP/PMF?
??Global New???? ??Biosimilar?t-NCE?
??????? ??????????
????
????????
???????
??
? GMP Good manufacturing practice PMF Plant
master file
?????
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?????????

• ??????????????????(99?1??)
• ????????????,???????????,????????????
• ??????
• Global New
• ?????(?????),???????????
• ????????????(Biosimilar)?t-NCE?
• ????????????,?????????

??????? 98? 99?1-7?
????? 100 25
??99?1-7?????????22?,8?????,
???2????,??6??A?/??????
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??????????????
10/6 ????
10/6 ????

• (??????99?9?30???????????)

MOU Memorandum of Understanding
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??4-.??????????(IND)????
?????(??????CRO)
TFDA??
??First-in Human ????????
??????????
????

??/?? ?????
??
?????
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?????????????

• (99?1??)
• ????????First-in-human?????????,???????,????????
• ?????????????????????????????,?????????
• ????????????,?????????

????/??? (???) 98? 99?1-7?
????????? 11/189 (5.8) 0/118 (0)
???????? 62/67 (92.5) 0/8 (0)
? ????????????????
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?????????????

• ??????,???????????
• ????FDA???????????IND/IDE,????????,????????????
• ??????,??????,????????????????????????????,?IRB???
  ?,????????
• ???????????????????????TFDA?CDE??????????????????

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??4-.?????/???????

• ?????????
• 99?4?????????????????
• 99?8?9????????????????????,???????????????
• ?????????????????,?????????
• ?????????
• ??????99?3?15???????????
• ???????????????????
• ??????????????,?????????,???????????????,??????1/3
  ??????

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??4-.??CTD???????(eCTD)??

• ?????????????????????????????????????
• ????????????????????????????????
• ??????????????,?????????,?????????
• ???????,?????????????,???????????????????,???????Q
  A?QC?

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???????????????

• ??1??????????
• ??2??????????
• ??3?????????????????
• ??4????????????
• ??5????????

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??1-. ??????????

• ???
• 5?20???????????????????????
• 7?12???????????????????????????
• 7?19?????????????????106? ??
• 10??????????????????????
• ???
• ???????? (99.9.30 ????????)

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??1-.???????????? (????)

• 99?5?20???????????????????????,????
• ?????????????
• ???????????
• ????????????,?????????????
• ??????????????????????

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????????

• ????????CPP??(??10?????)
• ??t-NCE????(??12?????)
• ??????????????(??11?????)
• ?????????????
• REMS (Risk Evaluation and Mitigation
  Strategy)(??12?????)
• )

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???????CPP??

• ???????????(????CPP),??????????????,??????????
• ?CPP???????,??????????????????
• ?????????????????????????,????????
• ???????????,?????????,??????????,?????????????

CPPCertificate of Pharmaceutical Product
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???????CPP??
Non-CPP
1-CPP
2-CPP
Expected review time 720 days ( 2 years)
Expected review time 300 days
Expected review time 200 days

1. Early phase clinical trials in
Taiwan 2. REMS/RMP
1. Pivotal clinical trials in Taiwan 2.
REMS/RMP if necessary
1. REMS/RMP if necessary
?CPP Certificate for Pharmaceutical Product from
10 advanced countries ?REMS/RMP Risk Evaluation
and Mitigation Strategy/ Risk management
plan ?expected review time does not include the
time for document supplementation and bridging
study
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??CPP?????

• ??Non-CPP?????
• ????
• ??????????????
• ???????????????????
• ?????????????,????????
• ??GCP?GLP????GMP??,????????????
• ?????????????(REMS/RMP),?????????
• ??????????????,?????????????,?????????????

GCP Good Clinical Practice GLP Good
Laboratory Practice
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???????????

• ??t-NCE????
• T-NCE Taiwan New Chemical Entity
• ???????????????????(???????)
• ?????????????,?????????
• ????????????????????,???????????
• ??FDA???????505b2??,??2006?????t-NCE??,???????????
  ?
• 99?8???t-NCE ????????????????checking list ??
• ?????????????????
• ???????????????,????????
• ????????

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???????????

• ??????????????
• ????????98?3????????????????????FDA????????????,??
  ???????,??????
• 99?7???????????????-?????????????
• ??99?9?28???????????,???????

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???????????

• ??????????????
• ??EU?????????,???????????????????????????????
• ???????????,??????????????????????? ? (8?27?????)
• 102????????????,??????????????
• 99?4???????????????

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???????????

• ?????????????
• ?????????????????????????????????????????,?99?1??,
  ?TFDA?????
• ????FDA???????,??????????????????,???????
• ????????????????
• ???????????????????,??????
• ????????????????????

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??2??????????
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• Preclinical GLP inspection
• Meet international standard
• GCP inspection
• Follow ICH