4. Supply of Ingredients

Ingredients Regulation Overview for Ingredient Manufacturers
Malaysia

This section provides information on any notification, registration, or importation requirements for the ingredient categories in scope.

4.1 As Drug Substances for Drug Manufacture (B2B)

4.1.1 Registration requirements

Separate registration of APIs is not required.

4.1.2 Importation

4.1.2.1 Overview of Process

Importers must hold an Import Licence in order to import and sell by wholesale or supply APIs from their premises. However, an import permit is not required for importation. 

The importer issues forwarding instructions to their appointed customs agent along with relevant shipping documents. The customs agent submits an Import Declaration electronically. 

4.1.2.2 Documents Required from the Ingredient Supplier

• Certificate of Origin may be required
• Certificate of Analysis 

4.1.3 Change Notification

A change to the API trade name would have no regulatory impact.

4.2 In Pharmaceutical Products Produced by Malaysian Manufacturers (B2C)

4.2.1 Registration of Drug Product

4.2.1.1 Registration Requirements

The applicant for drug product registration (Product Registration Holder) must be a locally incorporated company, corporate or legal entity, with a permanent address and registered with the Companies Commission of Malaysia (SSM) (with business scope related to health/pharmaceutical product).  

Mandatory control of the API through assessment of API data and information is part of the drug registration process. 

4.2.1.2 Registration Procedure

1. For applications in which a DMF is used, the DMF must be submitted prior to the drug application. The complete DMF is submitted by the DMF holder directly to the NPRA electronically (CD/DVD/USB/e-DMF) with a Letter of Access permitting the NPRA and PRH to reference the DMF.  
2. The PRH submits the application for drug product registration via the online submission system QUEST. Submission is based on the ASEAN Common Technical Document (ACTD)/ASEAN Common Technical Requirements (ACTR).
3. The application undergoes screening to ensure the required data/information has been provided. 
4. If screening is satisfactory, the application is accepted, payment is made and evaluation via the appropriate route is performed. Full evaluation is required unless the product has been registered in another country.

4.2.1.3 Documents to be Provided by Ingredient Supplier

For APIs

For Excipients

• Certificates of Analysis demonstrating compliance with quality standards (e.g. USP).

4.2.1.4 Cost and Timelines 

Note: Fees in Malaysian ringgit (MYR). 1 MYR = approx. 0.2 EUR/USD

4.2.1.5 Renewal Frequency and Cost

Registration is valid for five years. Re-registration incurs a fee of 1000 MYR.

4.2.2 Importation

Not applicable to locally manufactured products.

4.2.3 Change Notification Relating to API Trade Name Change

NPRA has adopted the ASEAN Variation Guideline for Pharmaceutical Products to determine requirements for the submission of a variation application. A change to the API name change would not be considered a change requiring approval or notification. 

4.3 As Active Substances for Health Supplements (B2B)

4.3.1 Registration Requirements

There is no requirement for health supplement active ingredients to be registered as long as they have been confirmed for use in health supplements by the NPRA. Ingredients can be searched using the NPRA Product Search. Vitamins and carotenoids are approved for use in health supplements.

4.3.2 Importation

As described in Section 4.1.2 above.

4.3.3 Change Notification

A change to the active substance trade name would have no regulatory impact.

4.4 In Health Supplements Produced by Malaysian Manufacturers (B2C)

4.4.1 Registration of Health Supplement

4.4.1.1 Registration Requirements

Health supplements must be registered for use by the Product Registration Holder. Requirements of the PRH are the same as for drug products. 

If an active substance is not approved for use in health supplements, information to support its safety of use and dose is required as part of the product registration process.

4.4.1.2 Registration Procedure

1. The PRH submits the application for health supplement registration via the online submission system QUEST. 
2. The application undergoes screening to ensure the required data/information has been provided. 
3. If screening is satisfactory, the application is accepted, payment is made and evaluation via the appropriate route is performed. A full evaluation is required for health supplements making disease risk reduction claims, otherwise, an abridged evaluation is performed. Currently, there are no disease risk reduction claims approved for vitamins.

4.4.1.3 Registration Documents to be Provided by Ingredient Supplier

For Active Ingredients

Certificate of analysis for each ingredient. Must include specifications and results of analysis.

For Excipients

None required

For Premixes

Since premixing of ingredients is considered part of the manufacturing process, a certificate of GMP from the ingredient supplier is required. The accepted standards of GMP are determined by the category of the product in the country of origin (e.g. if the product is classified as food, a GMP certificate of food standard issued by the relevant country authority will be accepted on the condition that the standards are similar to those practices in Malaysia).

4.4.1.4 Cost and Timelines

Health supplement fees are the same as for generic drugs. If a full evaluation is required, the timeline is 245 working days. For abridged evaluations, the timeline is 116 or 136 working days depending on whether the product contains a single or multiple active ingredients.

4.4.1.5 Renewal Frequency and Cost

As per drug products.

4.4.2 Importation

Not applicable to locally manufactured products.

4.4.3 Change Notification

Not applicable- as per Section 4.2.3 above.

4.5 As Ingredients for Veterinary Products (B2B)

4.5.1 Registration

Registration is not required for veterinary product ingredients.

Premixes that contain one or more active ingredients with excipients intended for medicinal purposes, that are supplied to an end user are considered drugs and must be registered as an imported drug product as per the registration process in Section 4.6. End users include in-farm, self-mixers, or home mixers of animal feed and feed millers.

4.5.2 Importation

See Section 4.1.2.

4.5.3 Change Notification

A change to the trade name of the active ingredient would have no regulatory impact.

4.6 In Veterinary Product Produced by Malaysian Manufacturers (B2C)

4.6.1 Registration

4.6.1.1 Overview of Process

Registration is required for veterinary products before supply in Malaysia. A comprehensive guideline is published by the NPRA on the requirements for registration of veterinary products. Similarly to human drug products, the applicant is the Product Registration Holder and must be a Malaysian entity. 

Application for product registration is either for:

1. Innovator product/New Chemical Entity
   1. New chemical entity
   2. New combination of existing chemical entities
   3. Existing chemical entity for use by different route of administration
2. Generic product

The application is submitted online and requires data as follows:

1. Administrative documentation
2. Quality documentation
3. Safety and residues documentation (for innovator products only)
4. Efficacy documentation (for innovator products only)

4.6.1.2 Documents Required from Ingredient Supplier

The manufacturer is required to submit the protocol for the analytical method/s used to test APIs and preservatives used, which should be in accordance with the official monograph of that ingredient in the latest edition of an official pharmacopeia such as the USP or BP. 

No documentation would be required from the ingredient supplier to support this activity unless the drug product manufacturer relies on the ingredient supplier’s certificate of analysis, in which case this should be provided.

4.6.1.3 Cost and Timeframes

For both innovator and generic products, registration costs 1,500 MYR.

4.6.1.4 Renewal Frequency and Cost

Registration is valid for five years. The fee for a product registration renewal is 1000 MYR (approx. 200 EUR/USD).

4.6.2 Importation

Not applicable to locally manufactured products.

4.6.3 Change Notification

A change to the trade name of the API would have no regulatory impact.

4.7 References

1. Drug Registration Guidance Document (DRGD) 3^rd Edition, 7^th Revision January 2024

https://npra.gov.my/easyarticles/images/users/1153/DRGD%20January%202024/MAIN-BODY-Drug-Registration-Guidance-Document-DRGD-3rd-Edition-7th-Revision-January-2024.pdf

2. Appendix 9 of the DRGD: Fees

https://www.npra.gov.my/easyarticles/images/users/1153/drgd_appendices/APPENDIX-9-Fees.pdf

3. Appendix 11 of the DRGD: Regulatory Control of APIs

https://npra.gov.my/easyarticles/images/users/1153/drgd_appendices/APPENDIX-11-Regulatory-Control-of-Active-Pharmaceutical-Ingredients-APIs.pdf

4. ASEAN Variation Guideline for Pharmaceutical Products

https://asean.org/wp-content/uploads/AVG-Revision-2-endorsed-31PPWG.pdf

5. Appendix 6 of the DRGD: Guidance on Registration of Health Supplements

https://npra.gov.my/easyarticles/images/users/1153/drgd_appendices/APPENDIX-6-Guideline-on-Registration-of-Health-Supplements.pdf

6. Registration Guideline of Veterinary Products Version 3, July 2014, Revised January 2024

https://www.npra.gov.my/easyarticles/images/users/1056/REGOVP_JULY2014_190124-18.pdf