Data exclusivity provides regulatory protection for undisclosed pharmaceutical test data, ensuring that innovators receive a defined period during which their clinical and safety data cannot be relied upon by third parties to gain marketing approval for generic versions. Southeast Asian jurisdictions vary significantly in how they regulate and enforce data exclusivity. Below is a summary of key provisions in Singapore, Malaysia, China, Vietnam, Indonesia, India, the Philippines, and Thailand.

Singapore

Under Section 19A of the Singapore Medicines Act, the Health Sciences Authority (HSA) protects confidential supporting information submitted with innovative medicinal product applications. Applicants benefit from a five-year exclusivity period during which third-party reliance on this information is prohibited.

Key features include:

• Confidential information encompasses trade secrets and commercially valuable data.
• Exemptions permit disclosure where necessary to protect public health, with applicant consent, or for regulatory cooperation with bodies such as WHO or WTO agencies.

Malaysia

Since March 2011, Malaysia has provided protection for undisclosed and unpublished pharmaceutical test data submitted to the Director of Pharmaceutical Services. Applications may be made for new chemical entities (NCEs) or second indications of registered products.

Duration:

• 5 years for new chemical entities.
• 3 years for second indications of registered drug products.

Applicants must file within 18 months (for NCEs) or 12 months (for second indications) of first approval in the country of origin or a recognized jurisdiction. Data exclusivity is granted on a case-by-case basis.

Vietnam

Guidelines issued in March 2010 by the Ministry of Health establish protection for undisclosed data supporting clinical trial results and product safety. The Ministry is responsible for keeping data confidential and preventing third-party reliance without consent.

Conditions for exclusivity include:

• Clinical trial reports for drugs with a new active ingredient.
• Data meeting trade secret standards and involving significant investment.
• Explicit request for exclusivity.

Duration: 5 years from the date of marketing approval.

Indonesia

Indonesia does not have explicit data exclusivity provisions. However, drug registration documents are considered confidential under Ministry of Health regulations and may only be used for evaluation purposes by competent authorities.

Hong Kong, the Philippines and Thailand

These jurisdictions currently provide no data exclusivity protection. Pharmaceutical data submitted for regulatory approval may not enjoy independent exclusivity periods, leaving applicants to rely on general trade secret or confidentiality principles.

Conclusion

Data exclusivity frameworks across Southeast Asia remain fragmented. Singapore, Malaysia, China, and Vietnam provide defined periods of protection, generally ranging from three to six years. Other jurisdictions, such as Indonesia, India, the Philippines, and Thailand, either rely on general confidentiality provisions or provide no explicit protection. Companies seeking to launch new chemical entities in the region should account for these differences in regulatory strategy.