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 …
Singapore HSA Publishes Cosmetic Products Guidance on Adverse Effects Reporting, Product Defects and Product Recalls
In December 2023, HSA’s Complementary Health Products Branch publishes guidance on “Procedures for Reporting of Adverse Effects, Product Defects and …
Singapore HSA Announces Upcoming Regulatory Fee Revision for Health Products
Singapore’s Health Sciences Authority (HSA) regulates health products to ensure that they meet the required standards of quality, safety and …
More News
#pharmaceuticalindustry
#regulatoryaffairs
ASEAN
Australia
Biologics/Biosimilars
Canada
China
Clinical Trials
Cosmetics
eCTD
EU
Global
Health Supplements
Herbal/Traditional Medicines
Hong Kong
India
Indonesia
Japan
Malaysia
Medical Devices
New Zealand
Pharmaceutical Drugs
Philippines
regulatory
Singapore
South Korea
Sri Lanka
Switzerland
Taiwan
Thailand
United Kingdom
United States
Vietnam