Singapore HSA Releases eCTD Specification Package for Implementation
“Singapore HSA’s Therapeutic Product Branch (TPB) is pleased to announce the release of the SG-HSA Specification version 1.0 package, effective …
Singapore HSA Updates Guidance for Post-Marketing Vigilance Requirements for Therapeutic Products & CTGTP
“On 7th Oct 2024, Singapore HSA updated Guidance for Post-Marketing Vigilance Requirements for Therapeutic Products & Cell, Tissue and Gene …
Singapore HSA Updates Guidance Documents for CTGTP
In September/October 2024, HSA has re-organized and updated Cell, Tissue or Gene Therapy Product (CTGTP) guidance on Product Notification, Product …
FDA Philippines Publishes General Rules and Regulations on the Registration of Pharmaceutical Products and Active Pharmaceutical Ingredients Intended for Human Use
Administrative Order 2024-0013 establishes updated rules for the registration of pharmaceutical products and Active Pharmaceutical Ingredients (APIs) for human use, …
Singapore HSA Updates Webpage on Nitrosamine Impurities in Medicines
Singapore Health Sciences Authority (HSA) has updated the webpages on nitrosamine impurities in medicines. The main webpage provides general information …
Singapore HSA Updates Therapeutic Products Guidances
As part of HSA’s ongoing initiative to improve regulatory efficiency and enhance clarity in Singapore’s regulatory requirements and processes, HSA …
New Refuse-to-File Mechanism for Pharmaceutical Registrations in Hong Kong Effective July 1, 2024
The Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances: Certification of Clinical Trial/Medicinal Test) Committee has announced the implementation …
Singapore HSA Updates Guidance for Post-Marketing Vigilance Requirements for Therapeutic Products & CTGTP
On 1st April 2024, Singapore HSA updated Guidance for Post-Marketing Vigilance Requirements for Therapeutic Products & Cell, Tissue and Gene …
Malaysia NPRA Updates Guideline for Application of Clinical Trial Import License (CTIL) and Clinical Trial Exemption (CTX)
Malaysia NPRA has revised the Malaysian Guideline for Application of Clinical Trial Import License (CTIL) and Clinical Trial Exemption (CTX) …