In recent years, the Thai FDA has made large-scale efforts to tighten its budget and escalate its standards of scrutiny. In response to these changes, this article provides insight into the practicability of Thailand’s regulatory framework governing the life sciences industry. This Q&A chapter provides an analysis of the critical legal issues and answers the essential legal questions surrounding areas such as the quality of national healthcare, manufacturing authorization, marketing and pricing of medicinal products, intellectual property, and the scope of product liability law in this industry. After reading this chapter, you will have a detailed understanding of the effect of key legislation and the power of regulatory authorities. In particular, the chapter covers:
- Pricing Structure: Costs and state funding of medicinal products and national healthcare
- Manufacturing: Authorization, conditions, fees, and validity of licenses
- Clinical Trials: Obtaining approval and procedural requirements during clinical trials
- Marketing: Fees, conditions, authorization, packaging requirements, foreign marketing authorizations, and restrictions such as marketing on the internet
- Traditional Medicine: Manufacturing and marketing regulations
- Patent Law: Conditions, patentable products, scope of protection, validity, revocation, infringement, and remedies available
- Trademark Law: Conditions, scope of protection, validity, revocation, infringement, remedies available, and relevant international conventions
- Product Liability Law: Key legislation, the substantive test, procedures of bringing a claim, defenses available, and remedies available under the Unsafe Goods Liability Act
- Proposals for Reform: The Trademark Bill, multiple-class applications, government fees, the Patent Bill, and a Drug Bill
This chapter was published by Practical Law Company, a leading provider of legal guidance, analysis, and market intelligence in up to 30 jurisdictions. To read the full article, please visit the PLC website.
