2014Revised Prescreening Checklist - SND

8/11/2019 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


2/21

#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.



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.




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




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.



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


6/21

,. % drug already approved by the -icensing %uthority mentioned in ule 1

proposed to be marketed 'ith ne' indication


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


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


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$



format9 of the dossier.



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


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




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.



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.




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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.


#o"es #o1. Application for permission to anufacture )%mport)Clinical


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



11/21

E9 ta#ilit" stud" data report as per reuirements of schedule ;

mentioning #atch si


12/21

c9 nderta,ing #" investigators as per Appendi@ 8%% of schedule ;

and C8.


recordings( Address( ualification( occupation( annual income of

su#Eects along with( name and address of nominee.




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.


13/21

#ote$



format9 of the dossier.



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.





thread 6%f there are too man" volumes e.g. more than 1'( then multiple grouping should #e

done9.






recognition 67C&9.





B& *n case the application is for clinical trial / Bio equivalence permission$





#. %n case of applications for protocol amendments of alread" approved studies( applicantsshould su#mit cop" of approval of protocol( amended new protocol( summari


14/21


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


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



15/21



m9 Comparative evaluation with pharmaceutical euivalence

international #rand6s9 or approved %ndian #rands( if

applica#le


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.



new dosage form ) new route of administration



mar,eted)approved for proposed odified Dosage orm along

with pac,age insert and)or copies of approval in ,e" countries.


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


; and C8.


recordings( Address( ualification( occupation( annual incomee9 Compensation clause as per &ule 122 DA



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.


16/21

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.



registration details.g9 Case record form 6C&9

h9 ite details( which includes %nvestigators name and address(




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$



format9 of the dossier.ii. >ard cop"+ ides and front of each volume) file )#inder must #e la#elled with the name


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.





thread 6%f there are too man" volumes e.g. more than 1'( then multiple grouping should #edone9.






recognition 67C&9.





B) *n case the application is for clinical trial / Bio equivalence permission$


17/21








18/21


proposed to be marketed 'ith %dditional Strength


#o"es #o

1. Application for permission to anufacture )%mport)Clinical


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


19/21

,9 Dissolution &elease 0rofile 6in case of oral dosage form9



m9 Comparative evaluation with international #rand6s9 or

approved %ndian #rands( if applica#le


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.


%nformation on active ingredients+


Additional trength



ar,eted) approved for proposed additional strength along with

pac,age insert and)or copies of approval in ,e" countries.


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


; and C8.






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.


20/21

d. %nform consent form 6with assurance of providing audio!video


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(




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$


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.



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


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


2014Revised Prescreening Checklist - SND

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