?????????? NDA – New Drug Application

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?????????? NDA New Drug Application
? ? ? Nov/17/2008
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Outlines

• Definition of New Drug ex DOH
• Guidance for Drug Registration
• General Requirements for a NDA in Taiwan
• What else shall be done before/during NDA?
• Common Technical Document, CTD

• BSE / CTW Application
• IND Application
• PMF Submission or Site Inspection

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Definition of New Drug

• Definition of New Drug ex DOH

• ???????7???????
• ?????,?????7???,??????????
• ?????????????????????????
• ???
• ???????????????? ???????
• ??????????,?????????????
• ?39??????????????????

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???????? Guidance for Drug Registration
http//www.doh.gov.tw/CHT2006/DM/SEARCH_RESULT.asp
x ???????? ????2008/07/03 164205 ????2008/08/
22 101804 ?????????????????.doc (Page 4,
7-35, 64-69) ??1-15.rar ??16-30.rar ??31-45.rar
??46-60.rar ??61-74.rar

• ?????????????????

(1, 2, 3, 8-15)
DRAFT !
(16, 17, 22-30)
(33, 35, 37-39, 42-45)
(46-58)
(63, 64, 66, 69)
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General Requirements for a NDA in Taiwan
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?????????

• Free Sales Certificate (FSC) or
• Certificate of Pharmaceutical Product (CPP)

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

1. ????????????????,????????????? 2.
??????????,?????????????????
??????????????(??????????)??? 3.
???????????????????????????,
??????????????,?????????????,
??????????????,????????????? ?????????? 4.
??????????????????????,?????? ?????????
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???????????????

• ????????????????????????????? ?????
• ??????????USPDI??????????(??????FDA)?????
• ??????Approved Prescription Drug Product
  With Therapeutic Equivalence
• Evaluations(Orange Book)?,?????????????????
  ?????
• ?????????,????FDA??????????
• 3. ??????????,??????????????????????,????
• ????( ????????????)?
• 4. ???????????(European Union,??????)??????,????
  
• ?????? The European Agency for the
  Evaluation of Medicinal Products
• (??EMEA)????????????
• 5. ?????????????????????????,??????????
• ?????????????????????????
• ??????????,?????????????????(bulk)??,???
• ????????????,?????????????????????????
• ????,????????????(bulk)????????
  ?????????
• ?????????,?????WHO Form????????,?????????
• ??????????????????
• 7. ??????????????????,??????,????FSC??????

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????
(?)????,??????,????????????????
??????????,??????????

• ??????????,???????????????????
• ????????????????????????(???
• ???,??????????????????????)?
• ?????????????????,?????????????
• ???,????????????(????)?????
• ????????????????,????????????
• ???????????????????
• 4. ??????????EMEA????????

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???? (???)
(?)???????????????????????(???????)
?????????????????????,????????
??????,????????????????????,???
???????????????

• ??Physicians Desk Reference(PDR)
• ??British National Formulary(B.N.F.)?
• ?Medicines Compendium?(published by
  Association of British
• Pharmaceutical Industries, ABPI)
• ????????(Drugs in Japan)????????
• ??Arzneimittel-Kompendium der Schweiz
• ???Compendium of Pharmaceuticals and
  Specialities
• ??Dictionnarie ViDAL
• ??MIM'S
• ??Rote Liste
• ???Repertoire Commente des Medicaments
• ??Farmacevtiska specialiteter i Sverige(FASS)

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???? - ??????????? ????

• ??????????????????????????,?????????
• ????????????,?????????,???????????????
• ??????????,????????? ?,???????????
• (1) ?????????????????????????
• (2) ??????GMP??,????????
• (3) ????????GMP??????
• (4) ??????????????????
• 2. ???1.???????????,?????????,???????????????
• ????,????????????????????????????????????
• ???????????(Bridging Study)?,????????????
• (1) ??????GMP??????????,?????????GMP
• ?????????????????
• (2) ??????????????????
• ?????????????????,?????????????????,?
• ?????,?????1.?2.????

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General Requirements for a NDA in Taiwan
Continued
12
General Requirements for a NDA in Taiwan
Continued
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General Requirements for a NDA in Taiwan
Continued
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What shall be done before/during NDA?

• CTW option
• If BSE and CTW applications could be approved
  by the DOH, the IND and
• clinical study would not be required.

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Lead Time 4 12 months
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Review of IND Application for New Drugs
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Plant Master File or Site Inspection
Re-filing
Site Inspection
or
PMF review
Re-filing
6 - 12 months

The applicant must file application 120 days
before the inspection
Reject
Approval
Appeal (within 4 months)
The applicant should file the SMF And application
fee in 45 days after notified by the BFDA.
Approval
Reject
Inspection and record with observation Report
signed mutually after site inspection.
File NDA at same time, before or after approval
Approval or Conditional approval
Reject
Total Time 818 Months
Total Time 511 Months
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Review of New Drug Applications
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????????? ????????????????

• ???/ ????????? ??
• ???/???????? ??
• 2008.03.07

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Common Technical Document ,CTD????
??????????? (Harmonization)????(Unify),???????????
??????????International Conference on
Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use
(ICH) ????????????????????????????,???????????????
????????CTD (Common Technical Document)???????????
???????
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CTD ??
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??????????????(eCTD)??????

• ???? 94??????????????
• ???? ICH? 2004?2??? eCTD
• specification version 3.2
• ???????????????

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eCTD ???????
??35??ICH ??????
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Thank You for Your Attention!