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Singapore HSA Guidance: Post-Marketing Vigilance Requirements for Therapeutic Products and CTGTPs in 2026
The Singapore Health Sciences Authority (HSA) has released Version 6 of its updated guidance document titled “Post-Marketing Vigilance Requirements for Therapeutic Products and Cell, Tissue and Gene Therapy Products (CTGTP)”, effective from 1 April 2026. The updated guidance provides important clarification on pharmacovigilance obligations, adverse event reporting, risk management plans (RMPs), and post-registration safety responsibilities for companies operating in Singapore
Sharan Murugan
Apr 303 min read