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THE PULSE OF GLOBAL PHARMA REGULATION
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ASIA-PACIFIC · NMPA · PMDA · TGA
APAC edition · 2025-12
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ARTICLE
APAC Regulatory Landscape Remains Stable
As we close out 2025, the regulatory environment across APAC remains consistent, with no significant updates from major authorities including PMDA, TGA, CDSCO, NMPA, and HSA. This stability allows for continued focus...
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REGULATORY · PMDA
PMDA Pre-Submission Consultation Fees
The PMDA continues to charge approximately USD 10,000 for a 2-hour pre-submission consultation meeting, maintaining its fee structure.
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REGULATORY · CDSCO
CDSCO Review Timelines
The review timelines for product categories in India continue to range from 6 to 18 months, providing a predictable framework for manufacturers.
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NEWS
HSA eCTD Portal Acceptance
The HSA's eCTD portal continues to operate under SG-HSA version 1.1, supporting electronic submissions for regulatory processes.
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Numbers of the month
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PMDA Consultation Fee
No Change
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CDSCO Review Timeline
No Change
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NMPA Testing Labs
No Change
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Official sources
- https://pmc.ncbi.nlm.nih.gov/articles/PMC9395591/
- https://www.pmda.go.jp/english/
- https://www.tga.gov.au/
- https://cdsco.gov.in/
- https://www.nmpa.gov.cn/
- https://www.hsa.gov.sg/
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www.novapharmanews.com
Crafted for APAC manufacturing, regulatory, and market-access teams.
APAC
· Edition 2025-12
· B2B pharma intelligence, generated and reviewed by editors.
© NovaPharmaNews. Trusted pharmaceutical intelligence covering FDA, EMA, NMPA, and PMDA regulatory developments across global markets.
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