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) …
Singapore HSA Updates Labelling Guideline for Therapeutic Products
On 28th March 2024, HSA revises “Appendix 7: Points to Consider for Singapore Labelling of the Guidance on Therapeutic Product …
Malaysia NPRA Update Guideline for Facilitated Registration Pathway (FRP)
Malaysia NPRA implement Guideline on Facilitated Registration Pathway: Abbreviated and Verification Review with the aim of increasing the efficiency of …
Singapore HSA Updates Software Medical Device Registration Requirements
Singapore HSA updated “GN-17 R3 Guidance on Preparation of a Product Registration Submission for GMD” and “GN-18 R3 Guidance on …
Singapore HSA and Republic of Korea MFDS sign MRA on GMP for Medicinal Products
On 26th February 2024, Singapore’s Health Sciences Authority (HSA) and the Ministry of Food and Drug Safety (MFDS)of the Republic …
Singapore HSA Updates Good Distribution Practice Guides for Therapeutic Products
In December 2023, HSA updated the following Good Distribution Practice (GDP) guides: – GUIDANCE NOTES ON GOOD DISTRIBUTION PRACTICE …
Singapore HSA Publishes List of Acceptable Intake for Nitrosamines
In March 2020, HSA had communicated the regulatory requirement to conduct risk assessments for all therapeutic products containing chemically synthesized …