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Product Registeration Regulatory Authority

PRODUCT REGISTRATION WITH NPCB (NATIONAL PHARMACEUTICAL CONTROL BUREAU):

For Malaysia, product registration is conducted through National Pharmaceutical Control Bureau.

Documents required for Health supplement product with Disease Risk Reduction claims (high claim).

NO.

FIELD

NO.

FIELD

GENERAL REQUIREMENTS*apply for general/nutritional claims, functional claims and disease risk reduction claims.

1

Product name

22

Finished product quality specifications

2

Brand name and product name

23

Stability data

3

Product description

24

Label for immediate container

4

Dosage form

25

Label for outer carton

5

Product indication/usage

26

Proposed package insert/Product information leaflet

6

Dose/Use instruction

27

Company name and address of product owner

7

Contraindication, if applicable

28

Company name and address of manufacturer(s)

8

Warning/Precautions, if applicable

29

Company name and address of repacker (if applicable)

9

Drug interaction, if applicable

30

Common name and address of other manufacturer (if applicable)

10

Side effects/ Adverse reactions, if applicable

31

Store address(s)

11

Signs and symptoms of overdose and treatment, if applicable

32

Importer (s)

12

Storage condition

33

Letter of authorization from product owner to product registration holder (if applicable)

13

Shelf life

34

Letter of Appointment of Contract Manufacturer/Repacker from Product Owner (if applicable)

14

Therapeutic code

35

Letter of Acceptance from Contract Manufacturer/Repacker (if applicable)

15

Batch Manufacturing Formula

36

Certificate of Pharmaceutical Product (CPP)

16

List of active ingredient(s)

37

Certificate of Free Sale (CFS)

17

List of excipient(s)

38

Certificate of Good Manufacturing Practice (GMP)

18

Attachment of Batch Manufacturing Formula

-          Product owner’s/manufacturer original letterhead, product details, date and signature & designation of authorized personnel

39

Attachment of protocol analysis

19

Manufacturing process

40

Attachment of Certificate of finished product (COA of finished product)

20

Attachment of manufacturing process

Document or manufacturing flow diagram

41

Attachment of Specifications and Certificate of Analysis (COA) of Active Ingredient

21

In-process quality control

ADDITIONAL REQUIREMENTS* apply for Disease Risk Reduction claims.

PRODUCT

SUBSTANCE

NO.

FIELD

NO.

FIELD

1

Description & composition

1

General information

2

Pharmaceutical development

2

Manufacture

3

Manufacturer

3

Characterization

4

Control of excipients

4

Control of health supplement substance

5

Control of finished products

5

Reference standards/materials

6

Reference standards/materials

9

Container closure system

7

Container closure system

7

Stability

8

Stability

9

Product Interchangeability/Equivalent evidence

 

Complete stability study conducted at 30 ± 2 ºC / RH 75 ± 5%. IPQC, FPQC, protocol analysis and COA of finished product are required to be submitted 2 years after product registration with SAMPLE of the products. Failure on submission will cause the product be suspended until complete documents are submitted, the registration of the product will be terminated if the complete documents still  cannot be produced upon renewal of product registration 

                                                                                          

               Non Clinical Data 
(for new active ingredients , new combination
of active ingredients, new dose)           
               Clinical Data                                           
Overview of non-clinical testing strategy Clinical overview
Pharmacology Production development rationale
Pharmacokinetics Overview of Bio-pharmaceutics
Toxicology Overview of Clinical pharmacology
Integrated overview and conclusion Overview of Efficiency
Other toxicities study , if available Overview of Safety
References References

       

table1

                                                                                                                       Non-clinical data presentation

table2

               Clinical data presentation
Drug Registration Guidance Document (DRGD), First Edition. January 2013

Information obtained from Drug Registration Guidance Document (DRGD), First Editiondownload from http://npra.moh.gov.my/index.php/guidelines-central on 27th May 2014.