Traditional Medicine NPRA Registration Process: QUEST, Local Licence Holder and DCA Approval

To go to market in Malaysia, traditional medicines and topical proprietary medicines must first be registered with NPRA and obtain a MAL number before sale — you cannot sell first and register later. The backbone of the whole process is: apply for QUEST system membership -> submit the complete product data online -> exchange queries and supplements with NPRA -> send it to the Drug Control Authority (DCA) meeting for evaluation -> obtain the MAL number after approval. This article breaks down each step, the special requirements for foreign manufacturers, and the differences between imported and locally manufactured products. (For the full framework overview, see the Malaysia Traditional Medicine / Proprietary Medicine Regulation and Labelling Guide.)

Why must you register first?

Although traditional medicines are marketed as natural and herbal, as long as they carry therapeutic claims they belong to the medicine scope managed by NPRA (corresponding to Class T of MAL). The point of registration is to let the authority review the product's formulation, ingredients, specifications, source of manufacture and safety and quality data before it goes to market, confirming that the risks are controllable. Selling without registration is a violation, which is why the idea of "stock the shelves first, supplement documents later" does not work.

Registration process (overview)

1. Apply for QUEST system membership: prepare the company registration documents, letter of authorisation, proof of identity, etc., and complete the membership application; and purchase a USB Token from MSC Trustgate for online signing and login.
2. Submit the registration application online: log in to QUEST and attach the product formulation, ingredients, specifications, manufacturer information, and safety and quality data.
3. Exchange queries and supplements with NPRA: during review, NPRA may request supplementary or clarifying information, which must be answered one by one.
4. Send to the DCA meeting for evaluation: the case is sent to the Drug Control Authority (DCA) meeting for evaluation; once passed, the MAL number is issued, and only then may the product go to market.

Natural / traditional products are approved only after their safety and quality evaluation is passed, so whether the data is complete and credible directly affects how smoothly the review goes.

Practical highlights of each step

• QUEST membership and USB Token: this is the prerequisite threshold for entering the system; incomplete documents will get you stuck at the first gate. The USB Token is purchased individually, and we recommend arranging it in advance.
• Product data: the formulation and ingredients must correspond clearly, the specifications must be definite, and the manufacturer information must be complete; potent or controlled ingredients will raise the category and the intensity of review.
• Responding to queries: supplementing documents is the norm, not bad news; the more precise and well-supported your responses, the shorter the back-and-forth.
• DCA approval: this is the final checkpoint, and the MAL number is only issued after approval. Once you have the MAL number, do not forget to cross-check MAL registration number A / X / T / N / H category mapping to confirm the category, and prepare the label per Mandatory label items for registered medicines / traditional medicines.

Foreign manufacturers: a local licence holder must be appointed

A foreign company cannot register directly on its own. It must first appoint a local Malaysian company as the registration certificate holder (licence holder), and this local company is responsible for the registration application and subsequent compliance and adverse-reaction reporting. Take particular note: without approval, you must not change the formulation, manufacturer, indications or labelling on your own; any change should go through the formal channel for application.

Imported vs locally manufactured: what is the difference?

This is the part imported products most easily overlook. Depending on the product's source, the holder and labelling requirements differ:

• Imported products: a local holder must be appointed (a CNH / PRH / licence holder depending on the product category), who bears the registration and compliance responsibility; the label must also add the country of manufacture / country of origin and supply the statutory Malay or English information.
• Local manufacturers: may act as their own holder, printing the statutory information from the source, with fewer after-the-fact over-labelling issues.

In other words, for the same product, if it is imported, besides completing the registration process, there is the extra work of "finding the right local holder + country-of-origin labelling + label localisation." When classification judgement is involved, you also have to first confirm whether the product is a medicine or a cosmetic, see Is a medicated balm a medicine or a cosmetic?

Common mistakes / rejection scenarios

• Incomplete QUEST membership documents, getting stuck at the application stage.
• Product data (formulation, specifications, manufacturer, safety and quality) incomplete or inconsistent.
• A foreign manufacturer trying to submit on its own without first appointing a local licence holder.
• Using ingredients that are not permitted or controlled ingredients over the limit, leading to heightened review or even rejection.
• An imported product missing the country of manufacture / country of origin, or a label that is not localised.

Pre-market self-check checklist

• [ ] Have you completed the QUEST membership application and obtained the USB Token?
• [ ] Are the product formulation, ingredients, specifications, manufacturer, and safety and quality data complete and consistent?
• [ ] If you are a foreign manufacturer, have you appointed a local Malaysian licence holder?
• [ ] For an imported product, have you planned the local holder, country-of-origin labelling and label localisation?
• [ ] Have you confirmed that all ingredients are permitted and do not involve controlled substances / poisons over the limit?

Summary

The skeleton of traditional medicine registration is clear: QUEST online submission + local licence holder + complete data + DCA approval to obtain the MAL number. What really stretches out the timeline is usually not the process itself, but whether the data is complete and whether the classification was pinned down correctly from the start. Thinking through the holder, ingredients and label early saves a lot of backtracking.

Frequently asked questions (FAQ)

Q: How long does registration take? It depends on the completeness of the data and the DCA schedule; evaluating natural products takes time, so we recommend allowing ample lead time.

Q: Are there restrictions on ingredients? Yes. They must be permitted ingredients and must not be controlled substances / poison-list items over the limit; potent or controlled ingredients raise the category and the intensity of review.

Q: Can a foreign brand register on its own? No. It must appoint a local Malaysian company as the licence holder, who is responsible for registration and subsequent compliance.

Q: Can the formulation still be changed after obtaining the MAL number? Without approval you must not change the formulation, manufacturer, indications or labelling on your own; any change must go through the formal channel for application.

Conclusion

Traditional medicine registration = QUEST online + local licence holder + complete data + DCA approval to obtain the MAL number. Want to first confirm whether the classification and data are in order? Run a free label check now or get in touch with us.

This article is compiled from official NPRA guidance and is for reference only; actual compliance is determined by the latest NPRA DRGD text and review.