Quick Asian Regulatory Updates

In late September, Singapore’s HSA outlined a new eCTD portal program for drugs that will start in early 2025. This is an eCTD portal version 1.0, better than the previous .9 version. This new program will be in a voluntary test phase from March to September 2025 for new and generic drugs as well as DMF submittals. eCTD submissions are already used extensively by Western drug companies for passing on electronic data to various health authorities. There is no word whether this will become an obligatory program in Singapore in the future.

Japan’s PMDA continues to fight the Japan drug lag. Currently, Japan only gives conditional drug approvals when clear efficacy is proved via late-stage clinical trials. The PMDA is planning to increase the number of products for conditional approval by changing the requirement to drugs where clinical usefulness can be logically predicted. In addition, in an effort to foster more innovation in the pediatric drug area, the PMDA is planning to extend the re-examination period or in effect, the data protection period, two more years —  so instead of 8 to 10 years, now from 10 to 12 years. Finally, the PMDA will continue to enhance legislation that will make real-world data more acceptable for drug approvals.


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.