Pharmaceutical Regulation in Thailand: The Overview

TL;DR

Thai pharmaceutical regulation centres on the Drug Act B.E. 2510 (1967) (modern drugs), Traditional Medicine Act B.E. 2542 (1999), the Narcotics Code B.E. 2564 (2021), and the Psychotropic Substance Act B.E. 2518 (1975). The Food and Drug Administration (FDA-Thai, MoPH) handles registration, manufacturing GMP, import licensing, and pharmacovigilance. Pharmacist supervision is required at retail pharmacies under the Pharmacy Profession Act B.E. 2537 (1994).

Drug Classes

Registration Path

1. Pre-approval consultation with FDA-Thai Drug Bureau.
2. File application with dossier (CTD format generally accepted).
3. Quality + safety + efficacy review.
4. GMP audit of manufacturing site (Thai or foreign).
5. Issue of registration + import / domestic-sale licence.

Common Mistakes

• Importing "supplements" containing scheduled substances without FDA registration.
• Selling online without pharmacy licence.
• Skipping pharmacovigilance reporting.
• Foreign-brand parallel imports without registration.

FAQs

1. Online pharmacy legal in Thailand?

Only with valid pharmacy licence + pharmacist present + drug-class compliance; recent FDA notifications add e-commerce-specific rules.

Related Reading

• Importing Medicines
• Regulatory Law Hub