Other Asian Regulatory Updates

  • Japan’s PMDA will open its first overseas office in Bangkok in 2024 or at the latest by March 2025. The new PMDA office will interact with Southeast Asian countries and hopefully improve their knowledge of Japanese requirements.
  • China removes tariffs on 62 APIs for cancer drugs and 5 APIs for rare diseases according to their 2024 Tariff Adjustment Plan. In addition, other imported drugs will no longer be taxed including certain vaccines, gene therapies, and insulin drugs.
  • Malaysia increases reference countries for drug approval. In the past, Malaysia expedited drug registration if the drug already had EU or US approvals. Beginning in 2024, Malaysia’s NPRA has expanded the referenced regulatory agencies to include Australia, Switzerland, UK, Japan, and Canada. Referenced countries are eligible for a 120-day review and two referenced countries have already approved the drug. The review period will only be 90 days.
  • Singapore issued a new bill called the Health Information Bill to protect health data. The goal of this bill is to counteract cybersecurity threats. The bill hopes to tighten up health information used by doctors, health institutions, and other systems. In addition, Singapore’s HSA will increase their government fees for medical devices, drugs, cell tissue and gene therapy products as well as other government services by a minimum of $1 Singapore dollar to a maximum of $200 Singapore dollars per fee item on July 1, 2024.

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.

Source used in the article: https://asia.nikkei.com/Business/Health-Care/Japan-s-pharmaceutical-regulator-to-open-office-in-Bangkok