Singapore’s Health Sciences Authority (HSA) has officially opened its new electronic Common Technical Document (eCTD) portal for test submissions. This represents an important move towards the process of digitalizing regulatory submissions for therapeutic products. The eCTD Specification Package version 1.0 will be available for test submissions from September 30, 2025, to March 27, 2026. During this time, it is recommended that companies submit test dossiers to become familiar with the use of the portal. The HSA has made it clear that the test submissions will not be reviewed, and all submissions will be discarded at the end of the testing period. Actual eCTD submissions to the portal can be made starting April 1, 2026.
The pharmaceutical market in Malaysia is predicted to grow steadily, with a new trade agreement with the US and increased government health expenditure. The US-Malaysia Agreement on Reciprocal Trade, signed on October 28, 2025, recognizes drug approvals from the US FDA. This will lead to a simplified approval process in Malaysia and increased patient access to drugs made in the US. According to Fitch Solutions, Malaysia’s drug market size is forecasted to experience a compound annual growth rate (CAGR) of 6.4% by 2029, with increased government health expenditure in 2026 to a record 46.5 billion MYR (about 11 billion USD).
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.