/ (New Drugs)

ASEAN HARMONIZATION
1

2550

2550

1
. 1
/ . 2

3
1. 3
2. 3
3. 1 (Part 1): 3
(ADMINISTRATIVE DATA AND PRODUCT INFORMATION)
4. 2 (Part 2) : (Quality Document) 5
5. 3 (Part 3) : ... 6
(Nonclinical Document )
6. 4 (Part 4) :
6
(Clinical Document)
7. .. 7

1 : .
9
/ ( .. 8 .. 8)
10
( .. 1 .1)
12
2 : (Model Certificate of a Pharmaceutical Product )
19
(Certificate of Free Sale)
3 :
27
ASEAN HARMONIZATION
4 : .
35
..
36
(New Drugs)..
37
U

2550

38
ii

..
..
5 : (Checklist)
.ND1
.ND2
.ND3
.ND4

39
41
42
43
47
54
59

2550

 / (New Drugs)
ASEAN HARMONIZATION

(New Drugs)
1. (New Chemical Entities)

2. (New Indication)
3. (New Combination)
/ 2

4. (New Delivery System)

Bioavailability
5. (New Route of Administration)
6. (New Dosage Form)

7. (New strength)

2
1. .. 8
..8
(One Stop Service Center)
2. .. 1 .1
(One Stop Service Center)

2550

2
/

1. /
2.
2.1 .. 8 /
.. 8
3 (One Stop Service Center)

2.2 .. 8 / .. 8
1 /
..8/..8
3.
3.1 .. 8 .. 8 2 ( 1)
3.2
3.3
3.4

2550

1.
/

2.
[ASEAN COMMON TECHNICAL DOSSIER
(ACTD) FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE]
(New Drugs) 4 (Parts)
1 (Part 1) (ADMINISTRATIVE DATA
AND PRODUCT INFORMATION)
2 (Part 2) (QUALITY DOCUMENT)
3 (Part 3) (NONCLINICAL
DOCUMENT)
4 (Part 4) (CLINICAL DOCUMENT)
U

3. 1 (Part 1): (ADMINISTRATIVE DATA

AND PRODUCT INFORMATION)
3 (Section) A, B C
A (Introduction)

U

ASEAN Harmonization .

B (Table of Contents)
1
C
(Documents required for registration)
1. ( 1)
1.1 ( ..1)
1.2 ASEAN HARMONIZATION ( .1)
U

2550

4
/
2. (Certificates)
2.1
-
- GMP
2.2
-
-(Certificate of Pharmaceutical Product)
(Certificate of Free Sale)
( 2)
- GMP (
)
3. (Labeling) ( 3)
4. (Product Information) ( 3)
4.1 Summary of Product Characteristics (SPC)
Product Data Sheet
4.2 (Package Insert, PI)
4.3 (Patient Information Leaflet, PIL)

(1.) NCE SPC SPC

PI PI
(2.) NCE SPC PI
SPC
(3.) PIL SPC/PI PIL
PIL PIL

(4.)

5. .8 .8

2550

5
6. (Applicant declaration) ( 4)
6.1
6.2
6.3
6.4
6.5 ()
-
- (
/ )
-
- Invoice Proforma Invoice Letter of
Credit ()
- ()
-
7.

8. -

9.
4. 2 (Part 2) : (Quality Document)
4 (Section) A,B,C D
A (Table of Contents)
2
B (Quality Overall Summary)
C (Body of Data)
D (Key Literature References)
2
(New Drugs) ASEAN HARMONIZATION

2550

6
5. 3 (Part 3) : (Nonclinical
Document )
5 (Section) A, B, C, D, E
A (Table of Contents)
3
B (Nonclinical Overview)
C
(Nonclinical Summary : Written and Tabulated)
D () (Nonclinical Study
Report) (as requested)
E (List of Key Literature References)
3
(New Drugs) ASEAN HARMONIZATION

U

6. 4 (Part 4) : (Clinical Document)

6 (Section) A, B, C, D, E F
A (Table of Contents)
4
B (Clinical Overview)
C (Clinical Summary)
D (Tabular Listing of All
Clinical Studies)
E () (Clinical Study Reports) ( If applicable)
F (List of Key Literature References)
4
(New Drugs) ASEAN HARMONIZATION

7.

2550

7

7.1 (Checklist)
7.1.1 . ND1 :
(New Drugs) ASEAN Harmonization 1
(Part 1) (Administratve data and Product information)
7.1.2 . ND2 : (Checklist of ASEAN
Common Technical Document : Part Quality) 2 (Part 2)
(Quality Document)
7.1.3 . ND3 :
(Checklist of ASEAN Common Technical Document : Part Nonclinical)
3 (Part 3) (Safety : Nonclinical Document)
7.1.4 . ND4 :
(Checklist of ASEAN Common Tecnical Document : Part Clinical) 4
(Part 4) (Efficacy : Clinical Document)
( .ND1, .ND2, .ND3 .ND4 5)
7.2 . . .

(1.)

(2.)

(3.)

1. . ND1 1 (Part1)
2. . ND2 2 (Part2)
3. . ND3 3 (Part3)
4. . ND4 4 (Part4)
1. .1
2. .1
3.
4. (Labeling)
5. (Product Information)
6.
7. . ND2 2 (Part2)
1. .1

2550

8
2 .1
3.
4. (Labeling)
5. (Product Information)
6.
7. -


8. . ND3 3 (Part3)
9. . ND4 4 (Part4)

7.3

NCE*
1

NI*
1

NCO*
1

ND*
1

4**

4**

4**

4**

4**

NR*
1

NDOS*
1

NS*
1

* NCE = New Chemical Entity, NI = New Indication, NCO = New Combination, ND = New Delivery system,
NR = New Route of administration, NDOS = New Dosage form of Approved New Drug,
NS = New Strength of Approved New Drug
** Part 3 Nonclinical 2

7.4 . (One Stop

Service Center)

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9
7.5
.
()

2550

1
/
.. 8
..8

.1
.1

10
.. 8
..............................................
...................................................
...................................

_________________
......................................
....................................................
...........................................................................
( )
....................................
.................................. /...........................
................................................... / ........................
/ ................................ .............................. ........................
................................................

.......

( )
.....................................................................................................................................

( )
( )
( ).................................
( ).................................

11
.. 8
.......................................
............................................
............................

________________
.
.......... ............................... ........
......................................... ..........................................
( )

.. / .............................. ...................................
................................. / .......................... / ......................
................................ ............................
...........................................................

1 .........

( )
..............................................................................................................................................
..............................................................................................................................................
2
( 1 )
( 2 )
( )...................................
( )...........................

12
.. 1
.............................................
..............................................
..............................

_______________

.
1. ( ) ............................................................................
............................................................................................
..............................................................................................
( ) .............................................
.........................................................................................
2. ( )
3. .......................................................................................................................
4. ................................... ........................... ...............
5. .........................................................
( )

6.
( )
( )
( )
7. .............................................................................................................
................................ / ............................... .................................
..................................... / ............................. / ......................
................................... ...................................
8. ..........................................................................................................
................................. / .............................. .................................
...................................... / ............................ / ......................
.................................. ....................................

13
9. ...................................................................
................................ / ............................... .................................
..................................... / ............................. / ......................
.................................. ....................................
10.

........................................ ........................................
( ) ........................................
_______________________________________________________________________________
: 9

14

( )


( ) ( )
........................( )

15
.1
.
..

(APPLICATION FORM OF ASEAN PHARMACEUTICAL REGISTRATION)

(Modern Drug) (Traditional Drug)
(Type) (Manufacture) (Repack) (Import)
(License number)
1. (DETAILS OF APPLICANT AND MANUFACTURER)
1.1
(Name of Authorisation Holder and Address)

................................ / ............................... .................................

..................................... / ............................. / ......................
................................. .........................
1.2 ( Manufacturers Name and Address)

................................ / ............................... .................................

..................................... / ............................. / ......................
................................. .........................
1.3
(Manufacturer responsible for final batch release s Name and Address)

................................ / ............................... .................................

..................................... / ............................. / ......................
................................. .........................

16
(Other manufacturers)
( Name and Address)

*(Role)

: * granulation
bulk, finished dosage form, contract research organization

17
2. (DETAILS OF PRODUCT)
2.1 (Product Name, Dosage Form and Strength)
(Product Name)....
(Dosage Form)
(Strength) .
2.2 ()

Product Description ()

2.3 (Generic Name and

Quantity of active ingredients and excipients)

(Generic Name)
(Reference)
(..)
Quantity/unit dose
(Active ingredients)





..



(Excipients)

18
3. (TECHNICAL DOCUMENTS)
3.1 (Quality Documents )
3.2 (Safety Documents )
3.3 (Efficacy Documents )
4. (PATENT/TRADEMARK EVIDENCE)
()
5. (REFERENCE PRODUCT)
()
6. (APPLICANT DECLARATION)

( ) ........................................

:- 9

19

2
(Model Certificate of a
Pharmaceutical Product)
(Certificate of Free Sale)

20
Model Certificate of a Pharmaceutical Product
Certificate of a Pharmaceutical Product 1
This certificate conforms to the format recommended by the World Health Organization
(general instructions and explanatory notes attached).
Certificate No : ______________________________
Exporting (certifying) country : ____________________________________________
Importing (requesting) country : ___________________________________________
P

1.
1.1

Name and dosage form of product :

___________________________________________
Active ingredient(s) 2 and amount(s) 3 per unit dose :
___________________________________________
___________________________________________
___________________________________________
For complete composition including excipients, see attached.4
P

1.2
1.3

Is this product licensed to be placed on the market for use in the exporting country? 5
Yes
No
Is this product actually on the market in the exporting country?
Yes
No
unknown
P

If the answer to 1.2 is yes, continue with section 2A and omit section 2B.
If the answer to 1.2 is no, omit section 2A and continue with section 2B. 6
P

2A.1

Number of product license 7 and date of issue :

___________________________________________
P

21
2A.2

Product-license holder (name and address) :

Name
: ___________________________________________
Address : ___________________________________________

Status of product-license holder : 8

a
b
c
2A.3.1 For categories b and c the name and address of the manufacturer producing the dosage form are : 9
Name
: ___________________________________________
Address : ___________________________________________

2A.3

2A.4

Is Summary Basis of Approval appended? 10

Yes
No
P

2A.5 Is the attached, officially approved product information complete and consonant with the license?11
(yes/no/not provided)
Yes
No
Not provided
P

2A.6

Applicant for certificate, if different from license holder (name and address) : 12
Name
: ___________________________________________
Address : ___________________________________________

2B.1

Applicant for certificate (name and address) :

Name
: ___________________________________________
Address : ___________________________________________

2B.2

Status of applicant : 8
a

2B.2.1 For categories b and c the name and address of the manufacturer producing the dosage form are : 9
Name
: ___________________________________________
Address : ___________________________________________
2B.3 Why is marketing authorization lacking?
not required
under consideration
not requested
refused
P

22
2B.4

Remarks : 13
________________________________________________

3.

Does the certifying authority arrange for periodic inspection of the manufacturing plant in which
the dosage form is produced? 14
Yes
No
N/A
If no or not applicable proceed to question 4.

3.1
3.2

Periodicity of routine inspections (years) : _____________________

Has the manufacture of this type of dosage form been inspected?
Yes
No

3.3

Do the facilities and operations conform to GMP as recommended by the

World Health Organization? 15
Yes
No
N/A
P

4.

Does the information submitted by the applicant satisfy the certifying authority on all aspects of
the manufacture of the product? 16
If no explain : ____________________________________
P

Address of certifying authority :

___________________________________________
Telephone number : _________________
Fax number : ________________________
Name of authorized person :
_________________________________________________
Signature of authorized person :
_________________________________________________
Stamp and date :
_________________________________________________

23
Explanatory notes
1 This certificate, which is in the format recommended by WHO, establishes the status of the pharmaceutical
product and of the applicant for the certificate in the exporting country. It is for a single product only since
manufacturing arrangements and approved information for different dosage forms and different strengths can
vary.
2 Use, whenever possible, International Nonproprietary Names (INNs) or national nonproprietary names.
3 The formula (complete composition) of the dosage form should be given on the certificate or be appended.
4 Details of quantitative composition are preferred, but their provision is subject to the agreement of the productlicense holder.
5 When applicable, append details of any restriction applied to the sale, distribution or administration of the
product that is specified in the product license.
6 Sections 2A and 2B are mutually exclusive.
7 Indicate, when applicable, if the license is provisional, or the product has not yet been approved.
8 Specify whether the person responsible for placing the product on the market :
(a) manufactures the dosage form;
(b) packages and/or labels a dosage form manufactured by an independent company; or
(c) is involved in none of the above.
9 This information can be provided only with the consent of the product-license holder or, in the case of nonregistered products, the applicant. Non-completion of this section indicates that the party concerned has not
agreed to inclusion of this information.
It should be noted that information concerning the site of production is part of the product license. If the
production site is changed, the license must be updated or it will cease to be valid.
10 This refers to the document, prepared by some national regulatory authorities, that summarizes the technical
basis on which the product has been licensed.
11 This refers to product information approved by the competent national regulatory authority, such as a Summary
of Product Characteristics (SPC).
12 In this circumstance, permission for issuing the certificate is required from the product-license holder. This
permission must be provided to the authority by the applicant.
13 Please indicate the reason that the applicant has provided for not requesting registration :
(a) the product has been developed exclusively for the treatment of conditions - particularly tropical
diseases - not endemic in the country of export;
(b) the product has been reformulated with a view to improving its stability under tropical conditions;
(c) the product has been reformulated to exclude excipients not approved for use in pharmaceutical
products in the country of import;
(d) the product has been reformulated to meet a different maximum dosage limit for an active ingredient;
(e) any other reason, please specify.

24
14 Not applicable means that the manufacture is taking place in a country other than that issuing the product
certificate and inspection is conducted under the aegis of the country of manufacture.
15 The requirements for good practices in the manufacture and quality control of drugs referred to in the
certificate are those included in the thirty-second report of the Expert Committee on Specifications for
Pharmaceutical Preparations (WHO Technical Report Series, No. 823, 1992, Annex 1). Recommendations
specifically applicable to biological products have been formulated by the WHO Expert Committee on
Biological Standardization (WHO Technical Report Series, No. 822, 1992, Annex 1).
16 This section is to be completed when the product-license holder or applicant conforms to status (b) or (c) as
described in note 7 above. It is of particular importance when foreign contractors are involved in the
manufacture of the product. In these circumstances the applicant should supply the certifying authority with
information to identify the contracting parties responsible for each stage of manufacture of the finished dosage
form, and the extent and nature of any controls exercised over each of these parties.

25
(Certificate of Free Sale)
1. CFS

CFS

1.1
1.2

1.3
2. CFS
2.1
2.2
2.2.1

2.2.2
CFS
3. CFS 1 2.1 2.2.1

4. CFS
4.1
4.2
4.3
4.4
-
- (model) individual products
5. CFS

6. CFS

26
7. CFS CFS

8. CFS CFS
CFS 2 CFS

398/2544 4 2544 122/2548 25

2548 477/2549 29 2549

27

3

ASEAN HARMONIZATION

28

ASEAN HARMONIZATION
(LABELLING)
ACTD 3 Unit Carton, Inner Label Blister/Strips

(UNIT CARTON)
1.
(Product name )
2.
(Dosage form)
3.
( Name of Active Ingredient(s) )
4.
( Strength of Active ingredient(s) )
5.
( Batch number )
6.
( Manufacturing date)
7.
( Expiration date )
8.
(Route of Administration )
9.
( Storage condition)
10. ( Countrys Registration Number)
11. ( Name and
address of Marketing Authorization Holder)
12. ( (
Name and address of manufacturer)
13. ( special labeling )
,
14. (Recommended Daily
Allowance)
15. (Warning)
16. (Pack sizes)
U

29
1. Unit Carton

2. . Dosage Form Route of Administration
2.1 Dosage form Tablet
Suppository XYZ Capsule
2.2 Route of administration IM IV
1 3

3. Recommended Daily Allowance % RDA
vitamins minerals % RDA RDA
Thai RDA RDA

4. Marketing Authorization Holder 11

INNER LABEL
1.
(Product name )
2.
* (Dosage form)
3.
( Name of Active Ingredient(s) )
4.
( Strength of Active ingredient(s) )
5.
( Batch number )
6.
* ( Manufacturing date)
7.
( Expiration date )
8.
(Route of Administration )
9.
* ( Storage condition)
10. * ( Countrys Registration Number)
11. * ( Name
and address of Marketing Authorization Holder)
12. (* (
Name and address of manufacturer)
13. * (special labeling )
,
U

30
14. * (Recommended Daily
Allowance)
15. * (Warning)
16. (Pack sizes)
* exempted for small ampoule and vial
1. Inner Label
2. small ampoule and vial
3
(BLISTER/STRIPS)
1. (Product name )
2. # ( Name of Active Ingredient(s) )
3. # ( Strength of Active ingredient(s) )
4. ( Batch number )
5. ( Expiration date)
6. / //
(country specific)
7. ( Countrys Registration Number) (country specific)
# 3

multivitamins and multiminerals
1. 6
2. 7

1.

2.
3
(Blister/Strips) Expiry date Exp
3.

31
(PRODUCT INFORMATION)
3
1. Package insert
2. Summary of Product Characteristics Product Data Sheet
3. Patient Information Leaflet (PIL)

Package insert
1. (Product name)
2. (Name and strength of active ingredient (s))
3. ( product description )
4. / (Pharmacodynamic/Pharmacokinetics)
5. (Indication)
6. (Recommended Dose)
7. (Mode of Administration )
8. ( Contraindication )
9. (Warning and Precaution)
10. ( Interactions with Other Medicaments)
11. ( Pregnancy and Lactation)
12. (Undesirable Effects)
13. (Overdose and Treatment)
14. ( Storage Condition)
15. (Dosage Forms and Packaging Available)
16. (Name and Address
of Manufacturing / Marketing Authorization Holder)
17. (Date of revision of package insert)

32
(Summary of Product Characteristics Product Data Sheet)
1. Name of the Medicinal Product
1.1 (Product Name)
1.2 (Strength)
1.3 ( Pharmaceutical Dosage Form)
2. ( Quality and Quantitative Composition)
2.1 (Qualitative Declaration)
INN hydrate
form
2.2 (Quantitative Declaration)
1 ( per dosage unit)

( For metered dose inhalation product, per puff)
3. ( Pharmaceutical Form)

100
4. ( Clinical Particulars)
4.1 (Therapeutic indication)
4.2 (Posology and method of adminnistration)
4.3 (Contraindication)
4.4 (Special warning and precautions for use)
4.5 (Interaction with other medicinal products and
other forms of interactions)
4.6 (Pregnancy and lactation)
4.7 (Effects on ability to drive and use
machine)
4.8 (Undesirable effects)
4.9 (Overdose)

33
5. ( Pharmacological Properties)
5.1 (Pharmacodynamic Properties)
5.2 (Pharmacokinetic properites)
5.3 (Preclinical Safety data)
6. ( pharmaceutical Particulars)
6.1 (List of excipient)
6.2 (Incompatibilities)
6.3 (Shelf life)

6.4 (Special precautions for storage)
6.5 (Nature and contents of container)
7. (Marketing Authorization
Holder)
8. ( Marketing Authorization Numbers)
9.(Date of authorization)
10. (Date of revision of the text)
Patient Information Leaflet PIL
1.
2.
3.
4.
5.
6.

( Name of Product)
( Description of Product)
( What is in the medicine?)
(Strength of the medicine)
(What is this medicine used for?)
( How much and how often should you use this
medicine?)
7. (When should you not take this medicine?)
8. (Undesirable effects)
9. (What other medicine or food
should be avoided whilst taking this medicine?)

34
10. (What should you do if you miss a dose?)
11. (How should you keep this medicine?)
12. (Sign & Symptom of over dosages)
13. (What to do when you taken more than the
recommended dosage?)
14. / //
(Name / logo of manufacturer/ importer/ marketing authorization)
15. (Care that should be taken when taking this medicine?)
16. (When should you consult your doctor?)
17. (Date of revision of PIL)

35

36

...

.
.
. .
/
1

1.
/ ... /
./.
....
.. .....

..
(...)
...... .. ..
...
(....)
...... .. ..

37
(New Drugs)
...

.......

.
.

1. ()
()

()
2. (Safety Monitoring Programme)
(Protocol)

3.
()

4.

.. 2510
( 5) .. 2530

()..
(.... )
...... .. ..

()..
(...)

38
...... .. ..

...
..

Country
Approval
Category /
Indication
Registration
Remark
Date
Condtion of
Name
Approval

()
USA

. .
Canada

UK
.
Sweden

Australia
..
Japan

.

.
Remark
1. Non Approval
2. Non Application
()..
()

...... .. ..
()
(....)
...... .. ..

39

.
(Patent)
(Non Patent)

Country
Application Date
Date of Patent granted
Term of Protection
(Expiry Date)

()

()..
()

...... .. ..
()
(....)

...... .. ..

40
1.

2. 1 2529-30
2534


3.

41

..
/ ..

.
()
.
()..
(...)
...... .. ..

42

5 : (checklist)
. ND1
. ND2
. ND3
. ND4

 . ND 1
1

43

(New Drugs) ASEAN HARMONIZATION.

1.

New Chemical Entity (NCE)

New Combination (NCO)
New Route of Administration (NR)
New Strength of Approved NCE (NS)

New Indication (NI)

New Delivery System (ND)
New Dosage form of Approved NCE (NDOS)

2.

1 (Part 1) :
(ADMINISTRATIVE DATA AND PRODUCT INFORMATION)
A (Section A) : (Introduction)
B (Section B) : ( Table of Contents)
C (Section C) :
1.
1.1 ( .1)
1.2 ASEAN
HARMONIZATION( .1)
2. (Certificates)
2.1
2.1.1
2.1.2 GMP
2.2
2.2.1

(Volume)

(Page)

()

 . ND 1
2

2.2.2
(Certificate of Pharmaceutical Product)
2.2.3 GMP
( 2.2.2)
3. (Labeling)
4. (Product Information)
4.1 Summary of
Product Characteristics (SPC) Product Data Sheet
4.2 (Package Insert, PI)
4.3
(Patient Information Leaflet, PIL)
5. /
5.1
( .8)
5.2
( .8)
6. (Applicant Declaration)
6.1
6.2
6.3
6.4
6.5 ()
6.5.1

6.5.2
(/ )
6.5.3
6.5.4 (
)
6.5.5

(Volume)

(Page)

44

()

 . ND 1
3

(Volume)

(Page)

()

7. (
)
8. -

9.
2 (Part 2) : (QUALITY
DOCUMENT)
3 (Part 3) :
(NONCLINICAL DOCUMENT)
4 (Part 4) :
(CLINICAL DOCUMENT)
___________________________
(
_ __________________
*
*
*
*
*
*
*
*
*
*

45

 . ND 1
4
1

...
...
...
...
...

__________________________
(

_ __________________
2

...
...
...
...

__________________________
(
_ __________________

46

 . ND 2
1

(Checklist of ASEAN Common Technical Document : Part Quality)

U

1.

New Chemical Entity (NCE)

New Combination (NCO)
New Route of Administration (NR)
New Strength of Approved NCE (NS)

New Indication (NI)

New Delivery System (ND)
New Dosage form of Approved NCE (NDOS)

2.

(Volume) (Page)
A (Section A) : (Table of Contents)
B (Section B) :
(Quality Overall Summary)
S (Drug Substance)
S1 (General Information)
S.1.1 (Nomenclature)
S.1.2 (Structure)
S.1.3 (General Properties)
S2 (Manufacture)
S.2.1 () (Manufacturer(s))
S.2.2
(Description of Manufacturing Process and Process
Controls)
S.2.3 (Control of Materials)
S.2.4
(Controls of Critical Steps and Intermediates)
S.2.5 /
(Process Validation and/or Evaluation)

()

47

 . ND 2
2

(Volume) (Page)
S.2.6
(Manufacturing Process Development)
S3 (Characterisation)
S.3.1
(Elucidation of Structure and Other Characteristics)
S.3.2 (Impurities)
S4 (Control of Drug Substance)
S.4.1 (Specification)
(Certificate of Analysis)
S.4.2 (Analytical Procedure)
S.4.3
(Validation of Analytical Procedures)
S.4.4 (Batch Analysis)
S.4.5
(Justification of Specification)
S5
(Reference Standards or Materials)
S6 (Container Closure System)
S7 (Stability)
P (DRUG PRODUCT)
P1 (Description and Composition)
P2 (Pharmaceutical Development)
P.2.1
(Information on Development Studies)
P.2.2
(Components of the Drug Product)
P.2.3 (Finished Product)
P.2.4
(Manufacturing Process Development)
P.2.5 (Container Closure System)
P.2.6 (Microbiological Attributes)
P.2.7 (Compatibilty)

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(Volume) (Page)
P3 (Manufacture)
P.3.1 (Batch Formula)
P.3.2
(Manufacturing Process and Process Controls)
P.3.3
(Controls of Critical Steps and Intermediates)
P.3.4 /
(Process Validation and/or Evaluation)
P4 (Control of Excipients)
P.4.1 (Specifications)
(Certificate of Analysis)
P.4.2 (Analytical Procedure)
P.4.3
(Excipients of Human or Animal Origin)
P.4.4 (Novel Excipients)
P5 (Control of Finished Product)
P.5.1 (Specification)
(Certificate of Analysis)
P.5.2 (Analytical Procedure)
P.5.3
(Validation of Analytical Procedures)
P.5.4 (Batch Analyses)
P.5.5
(Characterisation of Impurities)
P.5.6
(Justification of Specifications)
P6 (Reference Standards or
Materials)
P7 (Container Closure System)
P8 (Stability)
P9 (Product
Interchangeability Equivalence Evidence)

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4

(Volume) (Page)
C (Section C) : (Body of Data)
S (Drug Substance)
S1 (General Information)
S.1.1 (Nomenclature)
S.1.2 (Structure)
S.1.3 (General Properties)
S2 (Manufacture)
S.2.1 () (Manufacturer(s))
S.2.2
(Description of Manufacturing Process and Process
Controls)
S.2.3 (Control of Materials)
S.2.4
(Controls of Critical Steps and Intermediates)
S.2.5 /
(Process Validation and/or Evaluation)
S.2.6
(Manufacturing Process Development)
S3 (Characterisation)
S.3.1
(Elucidation of Structure and Other Characteristics)
S.3.2 (Impurities)
S4 (Control of Drug Substance)
S.4.1 (Specification)
(Certificate of Analysis)
S.4.2 (Analytical Procedure)
S.4.3
(Validation of Analytical Procedures)
S.4.4 (Batch Analysis)
S.4.5
(Justification of Specification)

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 . ND 2
5

(Volume) (Page)
S5
(Reference Standards or Materials)
S6 (Container Closure System)
S7 (Stability)
P (DRUG PRODUCT)
P1 (Description and Composition)
P2 (Pharmaceutical Development)
P.2.1
(Information on Development Studies)
P.2.2
(Components of the Drug Product)
P.2.3 (Finished Product)
P.2.4
(Manufacturing Process Development)
P.2.5 (Container Closure System)
P.2.6 (Microbiological Attributes)
P.2.7 (Compatibilty)
P3 (Manufacture)
P.3.1 (Batch Formula)
P.3.2
(Manufacturing Process and Process Controls)
P.3.3
(Controls of Critical Steps and Intermediates)
P.3.4 /
(Process Validation and/or Evaluation)
P4 (Control of Excipients)
P.4.1 (Specifications)
(Certificate of Analysis)
P.4.2 (Analytical Procedure)
P.4.3

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 . ND 2
6
(Excipients of Human or Animal Origin)

(Volume) (Page)

()

P.4.4 (Novel Excipients)

P5 (Control of Finished Product)
P.5.1 (Specification)
(Certificate of Analysis)
P.5.2 (Analytical Procedure)
P.5.3
(Validation of Analytical Procedures)
P.5.4 (Batch Analyses)
P.5.5
(Characterisation of Impurities)
P.5.6
(Justification of Specifications)
P6 (Reference Standards or
Materials)
P7 (Container Closure System)
P8 (Stability)
P9 (Product
Interchangeability Equivalence Evidence)
D (Section D) : ()
(Key Literature Reference, if applicable)
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 . ND 3
1

(Checklist of ASEAN Common Technical Document : Part Nonclinical)

U

1.

New Chemical Entity (NCE)

New Combination (NCO)
New Route of Administration (NR)
New Dosage form of Approved NCE (NDOS)

New Indication (NI)

New Delivery System (ND)
New Strength of Approved NCE (NS)

2.

(Volume) (Page)
A (Section A) : (Table of Contents)
B (Section B) :
(Nonclinical Overview)
1. (General Aspects)
2.
(Content and Structural Format)
C (Section C) :

(Nonclinic Summary : Written and Tabulated)

1.
(Nonclinical Written Summary )
1.1 (Pharmacology)
1.1.1
(Primary Pharmacodynamics)
1.1.2
(Secondary Pharmacodynamics)
1.1.3 (Safety pharmacology)
U

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(Volume) (Page)
1.1.4
(Pharmacodynamic Drug Reactions)
1.2 (Pharmacokinetics)
1.2.1 ( Absorption)
1.2.2 ( Distribution)
1.2.3 (Metabolism)
species ( inter species comparison)
1.2.4 (Excretion)
1.2.5 (
) Pharmacokinetic Drug Interaction
(Non-clinical)
1.2.6
(Other Pharmacokinetics Studies)
1.3 (Toxicology)
1.3.1
(Single Dose Toxicity )
1.3.2
( Repeat Dose Toxicity )
1.3.3 ( Genotoxicity)
1.3.4 (Carcinogenicity)
1.3.5
(Reproductive and developmental Toxicity)
1.3.5.1

(Fertility and Early Embryotic Development)

1.3.5.2 -
(Embryo-fetal Development)
1.3.5.3
(Pre-Natal and PostNatal Development including Maternal Function )
1.3.6 ( Local Tolerance)
1.3.7
(Other Toxicity Studies, if available)
U

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 . ND 3
3

(Volume) (Page)
2.
(Nonclinical Tabulated Summaries)
D (Section D)
( ) (Nonclinical Study Report ( As requested))
1. (Table of Content)
2. (Pharmacology)
2.1 (Primary Pharmacodynamics)
2.2 (Secondary Pharmacodynamics)
2.3 (Safety Pharmacology)
2.4
(Pharmacodynamics Drug Interactions)
3. (Pharmacokinetics)
3.1
(Analytical Methods and Validation Reports)
3.2 (Absorption)
3.3 (Distribution)
3.4 (Metabolism)
3.5 (Excretion)
3.6
() Pharmacokinetics Drug
Interaction (non-clinical)
3.7
(Other Pharmacokinetics studies)
4. (Toxicology)
4.1
(Single dose toxicity)
4.2 (Repeat dose toxicity)
4.3 (Genotoxicity)
4.3.1 (in vitro)
4.3.2 (in vivo)
4.4 (Carcinogenicity)
4.4.1 (Long-term studies)

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(Volume) (Page)

()

4.4.2
(Short or medium term studies)
4.4.3 (Other studies)
4.5
(Reproductive and developmental Toxicity)
4.5.1

(Fertility and Early Embryotic Development)

4.5.2 -
(Embryo-fetal Development)
4.5.3
(Pre-Natal and Post-Natal
Development including Maternal Function )
4.5.4 /
(Studies in which the offspring are
dosed and/or further evaluated)
4.6 ( Local tolerance)
4.7 ( )
(Other toxicity studies, if available)
4.7.1 (Antigenicity)
4.7.2. (Immunotoxicity)
4.7.3 (Dependence)
4.7.4 (Metabolites)
4.7.5 (Impurities)
4.7.6 (Other)
E (Section E) ( List of Key
Literature Reference)

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)
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 . ND 4
1

(Checklist of ASEAN Common Technical Document : Part Clinic)

U

1.

New Chemical Entity (NCE)

New Combination (NCO)
New Route of Administration (NR)
New Strength of Approved NCE (NS)

New Indication (NI)

New Delivery System (ND)
New Dosage form of Approved NCE (NDOS)

2.

(Volumn) (Page)

A (Section A) : (Table of Contents)

B (Section B) :
(Clinical Overview)
1. (Product Development
Rationale)
2. (Overview of Biopharmaceutics)
3. (Overview of Clinical
Pharmacology)
4. (Overview of Efficacy)
5. (Overview of Safety)
6. (Benefits and Risks
Conclusions)

C (Section C) :
(Clinical Summary)
1.
(Summary of Biopharmaceutic Studies and
Associated Analytical Method)

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2

(Volumn) (Page)
1.1 (Background and Overview)
1.2 (Summary of
Results of Individual Studies)
1.3
(Comparison and Analyses of Results Across Studies)
1 (Appendix 1)
2. (Summary of
Clinical Pharmacology Studies)
2.1 (Background and Overview)
2.2 (Summary of
Results of Individual Studies)
2.3
(Comparison and Analyses of Results Across Studies)
2.4 (Special Studies)
2 (Appendix 2)
3. (Summary of Clinical
Efficacy)
3.1
(Background and Overview of Clinical Efficacy)
3.2 (Summary of
Results of Individual Studies)
3.3
(Comparison and Analyses of Results Across Studies)
3.4
(Analysis of Clinical Information Relevant to Dosing
Recommendations )

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(Volumn) (Page)
3.5 /
(Persistence of Efficacy and/or Tolerance Effects)
3 ( Appendix 3)
4. (Summary of Clinical
Safety)
4.1 (Exposure to the Drug)
4.2 (Adverse Events)
4.3 (Clinical
Laboratory Evaluations)
4.4 , ,
(Vital Signs, Physical Findings,
and Other Observations Related to Safety )
4.5 (Safety
in Special Groups and Situations)
4.6 (Post-marketing Data)
4 (Appendix 4)
5. (Synopses of Individual
Studies)

Section D.
( Tabular Listing of All Clinical Studies)
Section E. (Clinical
Study Reports (if applicable)
1. (Reports of
Biopharmaceutic Studies)
1.1 BA (BA Study Reports)
1.2 BA BE (Comparative
BA or BE Study Reports)

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(Volumn) (Page)
1.3
(In vitro-In vivo Correlation Study
Reports)
1.4
(Reports of Bioanalytical and Analytical
Methods for Human Studies)
2.
(Reports of Studies Pertinent to Pharmacokinetics
using Human Biomaterials)
2.1 (Plasma
Protein Binding Study Reports)
2.2
(Reports of Hepatic Metabolism and Drug Interaction
Studies)
2.3 (Reports of
Studies Using Other Human Biomaterials)
3. (Reports of
Human Pharmacokinetic (PK) Studies
3.1 PK
(Heatthy Subiect PK and Initial
Tolerability Study Reports)
3.2 PK
(Patient PK and Initial Tolerability Study Reports)
3.3 PK (Population
PK Study Reports)

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(Volumn) (Page)
4. (Reports of
Human Pharmacodynamic (PD) Studies)
4.1 PD PK/PD
(Healthy Subject PD and PK/PD Study Reports)
4.2 PD PK/PD (Patient PD
and PK/PD Study Reports)
5.
(Reports of Efficacy and Safety Studies)
5.1
(Study Reports of Controlled Clinical
Studies Pertinent to the Claimed Indication)
5.2
(Study Reports of Uncontrolled Clinical Studies
5.3

(Reports of Analyses of Data from More Than One Study,
Including Any Formal Integrated Analyses, Meta-analyses,
and Bridging Analyses )
5.4 (Other Clinical Study
Reports)

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6

(Volumn) (Page)

()

6. (Reports
of Post-Marketing Experience)
7.
(Case Report Forms and Individual
Patient Listing)
Section F. (List of Key
Literature References)

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*
*
*
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*
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*
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7

* 1

...
...
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65