Traditional Product Registration

Guiding herbal and traditional medicine manufacturers through the NPRA registration process. Ensuring quality, safety, and correct therapeutic claims.

Contact / Enquire

Service Overview

Traditional Medicines (TM) in Malaysia include herbal products, homeopathic medicines, and traditional preparations (Malay, Chinese, Indian). These products must be registered with the Drug Control Authority (DCA) to ensure they are free from adulterants and heavy metals.

ARCI specializes in the specific quality control parameters required for TMs, including heavy metal limits, microbial contamination tests, and the prohibition of synthetic adulterants.

Who This Is For

  • Herbal product manufacturers.
  • Traditional medicine practitioners selling commercial products.
  • Importers of TCM or Ayurveda products.

Registration Requirements

1. Safety Testing

Coordination of lab testing for Heavy Metals (Lead, Mercury, etc.) and Microbial Contamination.

2. Adulterant Screening

Mandatory screening to prove the absence of steroids, sildenafil, and other scheduled poisons.

3. Claims Substantiation

Guidance on permitted "Traditionally Used For..." claims based on recognized pharmacopoeias.

4. Post-Market Surveillance (PMS) Support

Advisory and operational support to product registration holders in meeting post-market obligations, including:

  • Adverse Drug Reaction (ADR) Reporting
  • Product Quality Complaints
  • Recall System Setup

Traditional Registration FAQs

Can I register text-based traditional medicines? ▼
Yes, provided the formulation is documented in a recognized pharmacopoeia or has a history of safe use. We assist in referencing the correct monographs.
What is the registration timeline? ▼
The evaluation timeline from the authority is approximately 100 - 120 working days for standard registration, provided all data is complete and accurate upon submission.