2014revised prescreening checklist - snd
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1. Checklist for Grant of permission to manufacture/import of Bulk Drug already
approved in the country
S no Documents required to be submittednclosed !age no
"es #o
1. Name of Applicant with address
2. Name of Drug3. Therapeutic Class
4. Date of Approval
5. Application in orm!44 dul" filled and signed #" the
competent authorit"
$. Treasur" Challan of %N& 5'(''')! upto 1 "ear from initial
approval and %N& 15(''')! for other drugs upto 4 "ears*a. or manufacturing+!
Cop" of manufacturing license in orm!25) orm!2$ for an" #ul,
drug to manufacturer and orm!2-*#. or import+!
Cop" of drug sale license in orm 2' and 21
/. 0harmaceutical Chemical %nformation
A. anufacturing 0rocess including flowcharts detailed
manufacturing procedure(
i. %n process chec, procedure and report control
ii. atch manufacturing record
iii. 0rocess validation report.
. Complete monograph pecifications( methods of anal"sisincluding anal"tical method validation report( with
i. %dentification) uantification of impurities
ii. nantiomeric purit"
iii. &esidual solvent) other volatile impurities 678%9 estimation
C. tructural elucidation data
D. Three #atch Certificate of anal"sis
. ta#ilit" data of three different lots as per chedule :; of
Drugs and Cosmetics &ules 6 should #e presented in ta#ular form
with details of atch no( atch si
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#ote$
%& Submission requirements / methodology$
i. 0lease su#mit 7N hard cop" and T>& soft copies i.e. Compact Disc 6CD9
60D format( properl" #oo,mar,ed for navigation9 of the dossier.
ii. >ard cop"+ ides and front of each volume) file )#inder must #e la#elled with the name
of the applicant compan"( date of su#mission( name of the drug6s9 and the file
num#er 6Num#ering of files+ @ of " files e.g. if there are 1' files( file num#er $
will #e la#elled as ile No. $ ) 1'9.
iii. se of multiple volumes) files) #inders is recommended than #inding all the
documents and modules in a ver" huge file. 0refera#l" volumes) files )#inders
should not #e more than 3 inches thic, and use of good ualit" #inders is
recommended. All the files should #e ,ept together( #ound #" a good ualit" wire
or thread 6%f there are too man" volumes e.g. more than 1'( then multiple grouping
should #e done9.
iv. CDs have to #e la#elled using a mar,er pen with the name of the applicant compan"(date of su#mission and name of the drug6s9. %f there are multiple CDs for one su#mission
dossier( then the num#ering as mentioned a#ove should #e followed.
v. canned copies of onl" signed documents li,e test reports( signature pages will #e
accepta#le and rest of the document has to #e in 0D format with optical character
recognition 67C&9.
vi. The ta#le of content under each head should #e lin,ed to the files 6s9 or relevant
document for eas" trac,ing in CDs.
vii. Applicant should preserve a duplicate cop" of the su#mitted dossier for an" future
reference and should #e a#le to su#mit multiple copies( if reuired #" CDC7.
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2. %pprovals of a #e' drug ()ormulation& already approved in the country
S #o Documents required to be submittednclosed !age
no."es #o
1. Application for permission to anufacture )%mport+ 60urpose
should #e mentioned clearl"9
2. Name of the applicant and address3. Name of the New Drug
a. Composition of the New Drug
#. Dosage orm
c. 0roposed indication for the New Drug
d. Therapeutic rational for proposed dosage form
/. Details of the approval of the New Drug in the countr"
a. Approved Dosage orm
#. Approved composition
c. Approved indication
12. Application in orm 44 dul" signed and stamped #"
authori
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E9 ta#ilit" stud" data report as per reuirements of schedule
; mentioning #atch si
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#ote $
%& Submission requirements / methodology
i. 0lease su#mit 7N hard cop" and T>& soft copies i.e. Compact Disc 6CD9 60D
format( properl" #oo,mar,ed for navigation9 of the dossier.
ii. >ard cop"+ ides and front of each volume) file )#inder must #e la#elled with the name
of the applicant compan"( date of su#mission( name of the drug6s9 and the file
num#er 6Num#ering of files+ @ of " files e.g. if there are 1' files( file num#er $
will #e la#elled as ile No. $ ) 1'9.
iii. se of multiple volumes) files) #inders is recommended than #inding all the
documents and modules in a ver" huge file. 0refera#l" volumes) files )#inders
should not #e more than 3 inches thic, and use of good ualit" #inders is
recommended. All the files should #e ,ept together( #ound #" a good ualit" wire
or thread 6%f there are too man" volumes e.g. more than 1'( then multiple grouping
should #e done9.
iv. CDs have to #e la#elled using a mar,er pen with the name of the applicant compan"(date of su#mission and name of the drug6s9. %f there are multiple CDs for one su#mission
dossier( then the num#ering as mentioned a#ove should #e followed.
v. canned copies of onl" signed documents li,e test reports( signature pages will #e
accepta#le and rest of the document has to #e in 0D format with optical character
recognition 67C&9.
vi. The ta#le of content under each head should #e lin,ed to the files 6s9 or relevant
document for eas" trac,ing in CDs.
vii. Applicant should preserve a duplicate cop" of the su#mitted dossier for an" future
reference and should #e a#le to su#mit multiple copies( if reuired #" CDC7.
B& *n case the application is for Clinical +rial /Bio equivalence permission+
a. Adeuate chemical and pharmaceutical information should #e provided to ensure the
proper identit"( purit"( ualit" strength of the investigational product( the amount of
information needed ma" var" with the 0hase of clinical trials( proposed duration of trials(
dosage forms and the amount of information otherwise availa#le.
#. %n case of applications for protocol amendments of alread" approved studies( applicants
should su#mit cop" of approval of protocol( amended new protocol( summari
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,. % drug already approved by the -icensing %uthority mentioned in ule 1
proposed to be marketed 'ith ne' indication
S #o Documents required to be submittednclosed !age
no"es #o1. Application for permission to anufacture )%mport)Clinical
trial+ 60urpose should #e mentioned clearl"9
2. Name of the applicant with address
3. Name of the New Drua. Com osition of the New Dru
#. Dosage orm
c. 0roposed indication for the New Drug
d. Therapeutic rational for proposed indication
4. Details of the approval of the New Drug in the countr"
a. Approved Dosage orm
#. A roved com ositionc. A roved indication
5. Application in orm 44 dul" signed and stamped #" authori
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,9 Dissolution &elease 0rofile 6in case of oral dosage form9
l9 Comparative Dissolution &elease 0rofile with the Approved
formulation 6in case of oral dosage form9
m9 Comparative evaluation with pharmaceutical euivalence with
international #rand6s9 or approved %ndian #rands( if
applica#le
n9 Cop" of proposed 0ac,age %nsert which should include
generic name of all active ingredientsF compositionF dosage
form)s( indicationsF dose and method of administrationF use in
special populationsF contraindicationsF warningsF precautionsF
drug interactionsF undesira#le effectsF overdoseF
pharmacod"namics and pharmaco,inetic propertiesF
incompati#ilitiesF shelf!lifeF pac,aging informationF storage and
handling instructions.
o9 Draft specimen of ?a#el and Carton
Sr No 10 to 12 is not applicable, if applicant holds manufacturing or Import and
marketing permission for the proposed drug product [ Except 11(n and 11(o!
13. Therapeutic &ationale and Eustification for the proposed
Additional %ndication
14. &egulator" status in other countries( as appropriate.
a9 Names of the countries where the drug is
ar,eted) approved for proposed indication along with pac,age
insert and)or copies of approval in ,e" countries.
#9 Names of the countries where the drug is withdrawn( if
an"( with reasonsc9 ree sale certificate 6C9 or Certificate of
0harmaceutical 0roduct 6C7009( in case of import.
15. io uivalence)ioavaila#ilit" stud" 0rotocol 6As the case ma" #e9
a9 protocol
#9 tud" s"nopsis
c9 nderta,ing #" investigators as per Appendi@ 8%% od schedule
; and C8.
d9 %nform consent form 6with assurance of providing audio!video
recordings( Address( ualification( occupation( annual income
of su#Eects along with( name and address of nominee.
e9 Compensation clause as per &ule 122 DA
f9 Cop" of thics Committee approval letters along with
registration details.
1$. Clinical trial protocol in case of proposed Additional dosage form
is not approved in ,e" countries. 6Chec,list alread" given in New
Drug application9%. CT protocol
%%. tud" s"nopsis
%%%. nderta,ing #" investigators as per Appendi@ 8%% of schedule
; and C8.
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%8. %nform consent form 6with assurance of providing audio!video
recordings( Address( ualification( occupation( annual income
of su#Eects along with( name and address of nominee.
8. Compensation clause as per &ule 122 DA
8%. Cop" of thics Committee approval letters along with
registration details.
8%%. Case record form 6C&9
8%%%. ite details( which includes %nvestigators name and address(
T"pe of >ospital 6ultispecialt") =overnment) 0rivate9 (
Num#er of #eds( emergenc" facilities( thics Committee
registration details( etc9
1*. Gustification on Clinical trial waiver( if reuested.
1/. 0u#lished report of Clinical trial)Gournal)literature with respect to
proposed Additional %ndication.
#ote$
%& Submission requirements / methodology
i. 0lease su#mit 7N hard cop" and T>& soft copies i.e. Compact Disc 6CD9 60D
format9 of the dossier.
ii. >ard cop"+ ides and front of each volume) file )#inder must #e la#elled with the name
of the applicant compan"( date of su#mission( name of the drug6s9 and the file
num#er 6Num#ering of files+ @ of " files e.g. if there are 1' files( file num#er $ will
#e la#elled as ile No. $ ) 1'9.
iii. se of multiple volumes) files) #inders is recommended than #inding all thedocuments and modules in a ver" huge file. 0refera#l" volumes) files )#inders
should not #e more than 3 inches thic, and use of good ualit" #inders is
recommended. All the files should #e ,ept together( #ound #" a good ualit" wire or
thread 6%f there are too man" volumes e.g. more than 1'( then multiple grouping should #e
done9.
iv. CDs have to #e la#elled using a mar,er pen with the name of the applicant compan"( date
of su#mission and name of the drug6s9. %f there are multiple CDs for one su#mission
dossier( then the num#ering as mentioned a#ove should #e followed.
v. canned copies of onl" signed documents li,e test reports( signature pages will #e
accepta#le and rest of the document has to #e in 0D format with optical character
recognition 67C&9.
vi. The ta#le of content under each head should #e lin,ed to the files 6s9 or relevant document
for eas" trac,ing in CDs.
vii. Applicant should preserve a duplicate cop" of the su#mitted dossier for an" future
reference and should #e a#le to su#mit multiple copies( if reuired #" CDC7.
B&*n case the application is for clinical trial / Bio equivalence permission$
a.Adeuate chemical and pharmaceutical information should #e provided to ensure the proper
identit"( purit"( ualit" strength of the investigational product( the amount of information
needed ma" var" with the 0hase of clinical trials( proposed duration of trials( dosage forms
and the amount of information otherwise availa#le.
#. %n case of applications for protocol amendments of alread" approved studies( applicants
should su#mit cop" of approval of protocol( amended new protocol( summari
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the new changes incorporated along with Eustification ) reasons for the change.
c. thics Committee Approval+ thical approval should #e o#tained from thics Committee
located in the same area where the clinical trial site is located.
d. The proposed clinical trial stud" centres should #e geographicall" distri#uted in the
countr" and should also include clinical sites which have their own %nstitutional thics
Committee.
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0. % drug already approved by the -icensing %uthority mentioned in ule 1
and proposed to be marketed as a #e' Dosage )orm / #e' oute of
%dministration2.
S #o Documents required to be submittednclosed !age
#o"es #o1. Application for permission to anufacture )%mport)Clinical
trial+ 60urpose should #e mentioned clearl"9
2. Name of the applicant with address
3. Name of the New Drug
a. Com osition of the New Dru#. 0ro osed Dosa e ormc. 0roposed indication
d. Therapeutic rational for proposed New Dosage orm ) New
&oute
4. Details of the a roval of the New Dru in the countra. A roved Dosa e orm and route of administration#. A roved com ositionc. A roved indication
5. Application in orm 44 dul" signed and stamped #" authori
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E9 ta#ilit" stud" data report as per reuirements of schedule ;
mentioning #atch si
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c9 nderta,ing #" investigators as per Appendi@ 8%% of schedule ;
and C8.
d9 %nform consent form 6with assurance of providing audio!video
recordings( Address( ualification( occupation( annual income of
su#Eects along with( name and address of nominee.
e9 Compensation clause as per &ule 122 DA
f9 Cop" of thics Committee approval letters along with
registration details.
g9 Case record form 6C&9
h9 ite details( which includes %nvestigators name and address( T"pe
of >ospital 6ultispecialt") =overnment) 0rivate9 ( Num#er of
#eds( emergenc" facilities( thics Committee registration details(
etc9
1*. io uivalence stud" reuirement 6in case of oral dosage form as
appropriate as per Appendi@ H of chedule ;9
1/. Gustification on Clinical trial and io euivalence stud" waiver(
if reuested.
1-. Animal to@icolog" data as per chedule ;.
a&. Systemic to3icity studies4
i. single dose to@icit"
ii. repeated dose to@icit"
b&. -ocal to3icity
i. Dermal to3icity 6for products meant for topical
6dermal9 application9
ii. 5cular to3icity 6for products meant for ocular
instillation9
iii. *nhalation to3icity 6conducted with the formulation
proposed to #e used via inhalation route9
iv. 6aginal to3icity 6for products meant for topical
application to vaginal mucosa9
v. !hotoallergy or dermal phototo3icity 6reuired if the drug
or a meta#olite is related to an agent causing
photosensitivit" or the nature of action suggests such a
c&. ectal tolerance test 6or all preparations meant for rectal
administration9
2'. 0u#lished report of Clinical trial)Gournal)literature with respect to
proposed Dosage orm ) New &oute of Administration.
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#ote$
%& Submission requirements / methodology
i. 0lease su#mit 7N hard cop" and T>& soft copies i.e. Compact Disc 6CD9 60D
format9 of the dossier.
ii. >ard cop"+ ides and front of each volume) file )#inder must #e la#elled with the name
of the applicant compan"( date of su#mission( name of the drug6s9 and the file
num#er
6Num#ering of files+ @ of " files e.g. if there are 1' files( file num#er $ will #e
la#elled as ile No. $ ) 1'9.
iii. se of multiple volumes) files) #inders is recommended than #inding all the
documents and modules in a ver" huge file. 0refera#l" volumes) files )#inders
should not #e more than 3 inches thic, and use of good ualit" #inders is
recommended. All the files should #e ,ept together( #ound #" a good ualit" wire or
thread 6%f there are too man" volumes e.g. more than 1'( then multiple grouping should #e
done9.
iv. CDs have to #e la#elled using a mar,er pen with the name of the applicant compan"( date
of su#mission and name of the drug6s9. %f there are multiple CDs for one su#mission
dossier( then the num#ering as mentioned a#ove should #e followed.
v. canned copies of onl" signed documents li,e test reports( signature pages will #e
accepta#le and rest of the document has to #e in 0D format with optical character
recognition 67C&9.
vi. The ta#le of content under each head should #e lin,ed to the files 6s9 or relevant document
for eas" trac,ing in CDs.
vii. Applicant should preserve a duplicate cop" of the su#mitted dossier for an" future
reference and should #e a#le to su#mit multiple copies( if reuired #" CDC7.
B& *n case the application is for clinical trial / Bio equivalence permission$
a.Adeuate chemical and pharmaceutical information should #e provided to ensure the proper
identit"( purit"( ualit" strength of the investigational product( the amount of information
needed ma" var" with the 0hase of clinical trials( proposed duration of trials( dosage forms
and the amount of information otherwise availa#le.
#. %n case of applications for protocol amendments of alread" approved studies( applicantsshould su#mit cop" of approval of protocol( amended new protocol( summari
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7. % drug already approved by the -icensing %uthority mentioned in ule 1
no' proposed to be marketed as a 8odified release dosage form2.
S #o Documents required to be submittednclosed !age no
"es #o
1. Application for permission to anufacture )%mport)Clinical
trial+ 60urpose should #e mentioned clearl"9
2. Name of the a licant with address3. Name of the New Dru
a. Com osition of the New Dru#. Dosa e ormc. 0ro osed indication for the New Drud. Thera eutic rational for odified release dosa e form
4. Details of the a roval of the New Dru in the countra. A roved Dosa e orm and route of administration
#. A roved com ositionc. A roved indication
5. Application in orm 44 dul" signed and stamped #" authori
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l9 Comparative Dissolution &elease 0rofile with the Approved
formulation 6in case of oral dosage form9
m9 Comparative evaluation with pharmaceutical euivalence
international #rand6s9 or approved %ndian #rands( if
applica#le
n9 Cop" of proposed 0ac,age %nsert which should include
generic name of all active ingredientsF compositionF dosageform)s( indicationsF dose and method of administrationF use in
special populationsF contraindicationsF warningsF precautionsF
drug interactionsF undesira#le effectsF overdoseF
pharmacod"namic and pharmaco,inetic propertiesF
incompati#ilitiesF shelf!lifeF pac,aging informationF storage
and handling instructions.
o9 Draft specimen of ?a#el and Carton
13. Therapeutic &ationale and Eustification for the proposed
new dosage form ) new route of administration
14. &egulator" status in other countries( as appropriate.
a9 Names of the countries where the drug is
mar,eted)approved for proposed odified Dosage orm along
with pac,age insert and)or copies of approval in ,e" countries.
#9 Names of the countries where the drug is withdrawn( if
an with reasonsc9 ree sale certificate 6C9 or Certificate of
0harmaceutical 0roduct 6C7009( in case of import.
15. io uivalence)ioavaila#ilit" stud" 0rotocol 6As the case ma"#e9
a9 protocol
#9 tud" s"nopsis
c9 nderta,ing #" investigators as per Appendi@ 8%% od schedule
; and C8.
d9 %nform consent form 6with assurance of providing audio!video
recordings( Address( ualification( occupation( annual incomee9 Compensation clause as per &ule 122 DA
f9 Cop" of thics Committee approval letters along with
registration details.
1$. Clinical trial protocol in case of proposed Additional dosage form
is not approved in ,e" countries. 6Chec,list alread" given in New
Drug application9
a9 CT rotocol#9 tud" s"nopsis
c9 nderta,ing #" investigators as per Appendi@ 8%% of schedule
; and C8.
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d9 %nform consent form 6with assurance of providing audio!
video recordings( Address( ualification( occupation( annual
income of su#Eects along with( name and address of
nominee.
e9 Compensation clause as per &ule 122 DA
f9 Cop" of thics Committee approval letters along with
registration details.g9 Case record form 6C&9
h9 ite details( which includes %nvestigators name and address(
T"pe of >ospital 6ultispecialt") =overnment) 0rivate9 (
Num#er of #eds( emergenc" facilities( thics Committee
registration details( etc9
1*. io uivalence stud" reuirement 6in case of oral dosage form
as appropriate as per Appendi@ H of chedule ;9
1/. Gustification on Clinical trial and io euivalence stud" waiver( if
reuested.1-. 0u#lished report of Clinical trial)Gournal) literature with respect to
proposed odified Dosage orm.
2'. %n case of inEecta#le formulation( su#!acute to@icit" data
conducted with the applicant drug formulation.
#ote$
%& Submission requirements / methodology
i. 0lease su#mit 7N hard cop" and T>& soft copies i.e. Compact Disc 6CD9 60D
format9 of the dossier.ii. >ard cop"+ ides and front of each volume) file )#inder must #e la#elled with the name
of the applicant compan"( date of su#mission( name of the drug6s9 and the file
num#er 6Num#ering of files+ @ of " files e.g. if there are 1' files( file num#er $ will
#e la#elled as ile No. $ ) 1'9.
iii. se of multiple volumes) files) #inders is recommended than #inding all the
documents and modules in a ver" huge file. 0refera#l" volumes) files )#inders
should not #e more than 3 inches thic, and use of good ualit" #inders is
recommended. All the files should #e ,ept together( #ound #" a good ualit" wire or
thread 6%f there are too man" volumes e.g. more than 1'( then multiple grouping should #edone9.
iv. CDs have to #e la#elled using a mar,er pen with the name of the applicant compan"( date
of su#mission and name of the drug6s9. %f there are multiple CDs for one su#mission
dossier( then the num#ering as mentioned a#ove should #e followed.
v. canned copies of onl" signed documents li,e test reports( signature pages will #e
accepta#le and rest of the document has to #e in 0D format with optical character
recognition 67C&9.
vi. The ta#le of content under each head should #e lin,ed to the files 6s9 or relevant document
for eas" trac,ing in CDs.
vii. Applicant should preserve a duplicate cop" of the su#mitted dossier for an" future
reference and should #e a#le to su#mit multiple copies( if reuired #" CDC7.
B) *n case the application is for clinical trial / Bio equivalence permission$
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a.Adeuate chemical and pharmaceutical information should #e provided to ensure the proper
identit"( purit"( ualit" strength of the investigational product( the amount of information
needed ma" var" with the 0hase of clinical trials( proposed duration of trials( dosage forms
and the amount of information otherwise availa#le.
#. %n case of applications for protocol amendments of alread" approved studies( applicants
should su#mit cop" of approval of protocol( amended new protocol( summari
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9. % drug already approved by the -icensing %uthority mentioned in ule 1
proposed to be marketed 'ith %dditional Strength
S #o Documents required to be submittednclosed !age
#o"es #o
1. Application for permission to anufacture )%mport)Clinical
trial+ 60urpose should #e mentioned clearl"9
2. Name of the a licant with address3. Name of the New Dru
a. Com osition of the New Dru#. Dosage ormc. 0ro osed indication for the New Dru
4. Details of the approval of the New Drug in the countr"a. A roved Dosa e orm
#. A roved com osition
c. A roved tren th alon with %ndication5. Application in orm 44 dul" signed and stamped #" authori
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,9 Dissolution &elease 0rofile 6in case of oral dosage form9
l9 Comparative Dissolution &elease 0rofile with the Approved
formulation 6in case of oral dosage form9
m9 Comparative evaluation with international #rand6s9 or
approved %ndian #rands( if applica#le
n9 Cop" of proposed 0ac,age %nsert which should include
generic name of all active ingredientsF compositionF dosage
form)s( indicationsF dose and method of administrationF use in
special populationsF contraindicationsF warningsF precautionsF drug
interactionsF undesira#le effectsF overdoseF pharmacod"namics and
pharmaco,inetic propertiesF incompati#ilitiesF shelf!lifeF
pac,aging informationF storage and handling instructions.
o9 Draft specimen of ?a#el and Carton
%nformation on active ingredients+
13. Therapeutic &ationale and Eustification for the proposed
Additional trength
14. &egulator" status in other countries( as appropriate.
a9 Names of the countries where the drug is
ar,eted) approved for proposed additional strength along with
pac,age insert and)or copies of approval in ,e" countries.
#9 Names of the countries where the drug is withdrawn( if
an with reasons
c9 ree sale certificate 6C9 or Certificate of0harmaceutical 0roduct 6C7009( in case of import.
15. io uivalence)ioavaila#ilit" stud" 0rotocol 6As the case ma" #e9
a9 protocol
#9 tud" s"nopsis
c9 nderta,ing #" investigators as per Appendi@ 8%% od schedule
; and C8.
d9 %nform consent form 6with assurance of providing audio!video
recordings( Address( ualification( occupation( annual income
e9 Compensation clause as per &ule 122 DA
f9 Cop" of thics Committee approval letters along with
registration details.
1$. Clinical trial protocol in case of proposed Additional trength is not
approved in ,e" countries. 6Chec,list alread" given in New
Drug application9
a. CT protocol
#. tud" s"nopsis
c. nderta,ing #" investigators as per Appendi@ 8%% of schedule
; and C8.
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d. %nform consent form 6with assurance of providing audio!video
recordings( Address( ualification( occupation( annual income
of su# ects alon with( name and address of nominee.e. Compensation clause as per &ule 122 DA
f. Cop" of thics Committee approval letters along with
registration details.g. Case record form 6C&9
h. ite details( which includes %nvestigators name and address(
T"pe of >ospital 6ultispecialt") =overnment) 0rivate9 (
Num#er of #eds( emergenc" facilities( thics Committee
registration details( etc9
1*. Gustification on Clinical trial and io euivalence stud" waiver( if
reuested.
1/. 0u#lished report of Clinical trial)Gournal)literature with respect to
proposed Additional trength.
1-. %n case of inEecta#le formulation( su#!acute to@icit" data
conducted with the applicant drug formulation.
#ote$
%& Submission requirements / methodology
i. 0lease su#mit 7N hard cop" and T>& soft copies i.e. Compact Disc 6CD9 60D format9 of
the dossier.
ii. >ard cop"+ ides and front of each volume) file )#inder must #e la#elled with the name of
the applicant compan"( date of su#mission( name of the drug6s9 and the file num#er
6Num#ering of files+ @ of " files e.g. if there are 1' files( file num#er $ will #e
la#elled as ile No. $ ) 1'9.
iii. se of multiple volumes) files) #inders is recommended than #inding all the documents
and modules in a ver" huge file. 0refera#l" volumes) files )#inders should not #e more
than 3 inches thic, and use of good ualit" #inders is recommended. All the files should #e
,ept together( #ound #" a good ualit" wire or thread 6%f there are too man" volumes e.g.
more than 1'( then multiple grouping should #e done9.
iv. CDs have to #e la#elled using a mar,er pen with the name of the applicant compan"( date of
su#mission and name of the drug6s9. %f there are multiple CDs for one su#mission dossier( then
the num#ering as mentioned a#ove should #e followed.
v. canned copies of onl" signed documents li,e test reports( signature pages will #e accepta#le
and rest of the document has to #e in 0D format with optical character recognition 67C&9.
vi. The ta#le of content under each head should #e lin,ed to the files 6s9 or relevant document for
eas" trac,ing in CDs.
vii. Applicant should preserve a duplicate cop" of the su#mitted dossier for an" future
reference and should #e a#le to su#mit multiple copies( if reuired #" CDC7.
B) *n case the application is for clinical trial / Bio equivalence permission$
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8/11/2019 2014Revised Prescreening Checklist - SND
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a. Adeuate chemical and pharmaceutical information should #e provided to ensure the proper
identit"( purit"( ualit" strength of the investigational product( the amount of information
needed ma" var" with the 0hase of clinical trials( proposed duration of trials( dosage forms and
the amount of information otherwise availa#le.
b. %n case of applications for protocol amendments of alread" approved studies( applicants
should su#mit cop" of approval of protocol( amended new protocol( summari
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