Malaysia Traditional Medicine GMP: Manufacturer's Licence and Audit Explained

In Malaysia, the production of Traditional Medicine must comply with the Good Manufacturing Practice (GMP) for Traditional Medicines and Health Supplements set by the National Pharmaceutical Regulatory Agency (NPRA). GMP is not optional but a prerequisite for obtaining a Manufacturer's Licence; and the manufacturer's licence is in turn a precondition for the product to obtain a MAL registration number and be legally marketed. In other words: if the factory does not pass GMP, the product cannot be registered. The legal basis is the Control of Drugs and Cosmetics Regulations 1984.

Who must comply with GMP, and against what standard

• Local manufacturing: all local factories producing registered traditional medicines must pass NPRA's GMP audit and hold a manufacturer's licence.
• Imported products: overseas factories must provide proof of GMP equivalence (such as a GMP certificate / CoPP issued by the exporting country's competent authority), and NPRA reviews the compliance; overseas GMP is not automatically recognised.
• Audit standard: traditional medicines and health supplements apply the TMHS GMP Guidelines and are aligned with the PIC/S (Pharmaceutical Inspection Co-operation Scheme) system; this is a different level of requirement from the PIC/S GMP for Western medicines.

In June 2024 NPRA issued the fourth edition of the Guidance Document for Preparation of GMP Inspections on TMHSC, and manufacturers are advised to self-assess against the latest edition before applying. NPRA also subdivides natural products into five categories: traditional medicines, herbal remedies, finished herbal products, homeopathic medicines, and natural products with therapeutic claims; although classified differently, at the manufacturing end all uniformly apply the TMHS GMP requirements.

The core chapters GMP covers

Application and audit process (conceptual steps)

1. Build GMP-compliant premises, documentation and quality systems.
2. Apply to NPRA for a GMP audit and manufacturer's licence.
3. On-site audit (applying the corresponding standard by product category; traditional medicines use the TMHS GMP Guidelines).
4. Remediate deficiencies and close major / critical items.
5. Issue the GMP certificate and manufacturer's licence, only after which product registration can proceed.

The quality-control step actually tests whether the finished product's heavy metals and microbes are within limits; for this part read on with heavy-metal and microbial limits for traditional medicines; and for the overall process of whether a product can be legally marketed, return to the overview of traditional medicine registration to understand it together.

Grading and remediation of audit deficiencies

After an audit, NPRA usually grades deficiencies by severity, commonly into three types: critical, major and minor. Before critical or major deficiencies are closed, the GMP certificate and manufacturer's licence cannot be issued. In practice it is advised to:

• Establish an internal self-inspection mechanism to self-check one round before the official audit.
• Draw up corrective and preventive actions (CAPA) for each deficiency and keep evidence.
• Keep premises flow, raw-material warehousing and finished-goods warehouse clearly zoned to reduce cross-contamination risk.

As for audit fees and review timelines, they vary by product category and factory scale, and should be based on NPRA's fee schedule in force at the time, not estimated from hearsay amounts.

Differences between imported and local manufacturing

Local factories are “audited directly by NPRA + issued a manufacturer's licence”; imported products are “review of the overseas factory's proof of GMP equivalence.” The common bottom line for both is: the manufacturing end must reach a GMP level acceptable to NPRA; an importer cannot assume Malaysia will automatically recognise a product just because it is legally sold in the country of origin. Having complete, traceable overseas-factory GMP documents is one of the keys to whether an imported traditional medicine can be registered smoothly.

Common mistakes

• Assuming that a qualified formula is enough to go to market, ignoring that factory-end GMP is a precondition.
• Importers mistakenly believing overseas GMP is automatically recognised, without NPRA reviewing equivalence.
• Producing traditional medicines like ordinary food, with insufficient premises and QC capability.
• Incomplete batch records and SOPs, making traceability impossible during audit.

Frequently asked questions (FAQ)

Q: Can I register the product first without GMP? No. GMP and the manufacturer's licence are preconditions for the product to obtain a MAL number; a factory that has not passed GMP cannot register.

Q: Do imported traditional medicines also need GMP? Yes. The overseas manufacturing factory must provide proof of GMP equivalence (such as a GMP certificate / CoPP), and NPRA reviews the compliance.

Q: Which standard does traditional medicine GMP use? It applies NPRA's GMP Guidelines for Traditional Medicines and Health Supplements and is aligned with the PIC/S system, at a different level from pure Western-medicine GMP.

Q: Does the GMP certificate need periodic re-audit? Yes. NPRA conducts periodic re-audits on schedule, and manufacturers must continuously maintain compliance.

Q: Is traditional medicine GMP the same as Western medicine GMP? No. Both share the same legal basis (CDCR 1984), but traditional medicines and health supplements have dedicated GMP guidelines and audit-preparation documents.

Self-check list

• [ ] Confirmed the manufacturing factory (local or overseas) holds a valid GMP / manufacturer's licence
• [ ] Quality system, SOPs and batch records are complete and traceable
• [ ] Self-assessed against the fourth edition (2024) audit-preparation document
• [ ] QC has heavy-metal and microbial testing capability
• [ ] Imported products have proof of overseas GMP equivalence ready for NPRA review

Summary

The GMP for traditional medicines follows the logic of “the factory qualifies first, then the product is registered”: NPRA first audits the factory under the TMHS GMP Guidelines and issues a manufacturer's licence, only after which the product can enter MAL registration. Whether produced locally or imported, the manufacturing end's quality system is the foundation of compliance.

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This article is compiled from official sources and is for reference only; actual compliance is subject to the latest official text and review by the competent authorities.