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Malaysia updated the Drug Registration Guidance Document (DRGD)1 on October 20, 20232. The updates this time involve
Preamble
Section B: Product Registration Process
Section E: Post-Registration Process
Appendix 4: Guideline on Registration of Biologics
Appendix 19: General Labeling Requirements
Appendix 20: Specific Labeling Requirements
Appendix 32: Explanatory Notes for Repackers
Key revisions include:
✔ Substituting 21.2 Post-Market Surveillance, 21.3 Punitive Action by the Authority and 21.4 Notification of Product Quality of “Section E: Post-Registration Process” with 21.2 Product Quality Monitoring (PQM), 21.2.1 Product Quality Monitoring (PQM) Programme, 21.2.2 Product Sampling, 21.2.3 Product Testing, 21.2.4 Monitoring of Label Compliance, 21.2.5 Product Quality Reporting, 21.2.6 Risk Communication on Information of Product Issues, 21.2.7 Regulatory Action and 21.2.8 Adulteration.
✔ Regarding the changes of Appendix 19: General Labeling Requirements, this update further explains the requirements on stick-on label. It is said that stick-on label refers to an additional label affixed onto an approved immediate label and/or outer carton. The stick-on label shall not cover any information on the approved immediate label or outer carton. Permitted stick-on label are detailed in 11 situations. For the usage other than the 11 situations, they shall require prior approval by the Authority.
For detailed updates, please check LIST OF UPDATES FOR DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) THIRD EDITION, SIXTH REVISION OCTOBER 20233.
According to National Pharmaceutical Regulatory Agency (NPRA), Malaysia released the third edition, fifth revision of Drug Registration Guidance Document (DRGD) on July 25, 2023, which came into effect on July 31, 2023.
Major revisions compared to the previous version (third edition, fourth revision of DRGD released in January 2023) are listed below. Please note that the revisions may affect various products such as OTC products and natural products. However, this article only focuses the amendment associated with health supplement.
Key Revisions
1. Revisions to Section B: Product Registration Process
This update adds the e-labeling requirements for proposed packaged insert (PI) and consumer medication information leaflet (RiMUP). The revisions may affect some health supplement products. For example, health supplement products with disease risk reduction claims shall contain RiMUP at the outer carton, immediate container or blister/strips.
2. Revisions to Appendix 18: List of Permitted, Prohibited and Restricted Substances
A new prohibited active ingredient, pholcodine, is added into the list.
3. Revisions to Appendix 19: General Labeling Requirements
Before this amendment, registered product is required to have the same label artwork for all pack sizes, but now it is allowed to have minor differences in the color code to differentiate pack sizes.
Requirements regarding e-labeling is also added into this Appendix.
4. Revisions to Appendix 20: Specific Labeling Requirements
Products containing substances listed in Appendix 20 shall indicate specific information in the label, package insert and (or) RiMUP. This amendment adds the labeling requirements for azacitidine, griseofulvin, valaciclovir and chromium, as well as revises the information regarding alfalfa, senna, rhubarb and clindamyclin.
5. Revisions to Appendix 27: Inspection
Examples of situations subject to Immediate Notification and Periodical Notification are revised. E.g., If the manufacturing of health supplements and traditional medicines shares exactly the same manufacturing facility without any changes, then Immediate Notification need to be submitted to the Center of Compliance & Quality Control, NPRA for approval.
6. Revisions to Appendix 28: Licensing
Stakeholders wanting to manufacture, import or wholesale any registered products need to have a valid Manufacturer’s/Import/Wholesaler’s License. This amendment
Revises and adds the requirements for supporting documents that the applicant shall submit.
Clarifies that the application for Government Agencies shall be submitted through the ‘Application for Licence for Registered Product for Government Agencies’ form. Guideline for license application is also added.
Changes the description of license’s validity into “Each license is valid for one (1) year or until December 31 of the same year”
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Read more amendments in List of Updates for DRGD.
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