The Pharma Legal Handbook: Thailand

Thailand is one of Southeast Asia's most developed pharmaceutical markets, with a well-established regulatory framework administered by the Food and Drug Administration of Thailand (FDA Thailand). Thailand's healthcare system, which includes the Universal Coverage Scheme, provides broad access to medicines and creates significant public procurement opportunities.

Thailand has specific requirements around local clinical data for certain product categories and has been developing its bioequivalence requirements in line with international standards. The compulsory licensing framework is well established and has been used for a number of pharmaceutical products, which is a consideration for commercial planning.

The Pharma Legal Handbook: Thailand provides comprehensive guidance on pharmaceutical regulation in Thailand, covering FDA Thailand product registration, pricing and reimbursement frameworks, clinical trial requirements, pharmacovigilance obligations, manufacturing and GMP requirements, marketing rules, and intellectual property protection.