“Malaysia NPRA has revised the Malaysian Guideline for Application of Clinical Trial Import License (CTIL) and Clinical Trial Exemption (CTX) Edition 8.0, slated for publication on April 30, 2024.
This decision
read more...“Malaysia NPRA has revised the Malaysian Guideline for Application of Clinical Trial Import License (CTIL) and Clinical Trial Exemption (CTX) Edition 8.0, slated for publication on April 30, 2024.
This decision
read more...On 28th March 2024, HSA revises “Appendix 7: Points to Consider for Singapore Labelling of the Guidance on Therapeutic Product Registration in Singapore”. The guidance has been updated to include
read more...Malaysia NPRA implement Guideline on Facilitated Registration Pathway: Abbreviated and Verification Review with the aim of increasing the efficiency of the NPRA in pharmaceutical product registration.
The following information has been
read more...Singapore HSA updated “GN-17 R3 Guidance on Preparation of a Product Registration Submission for GMD” and “GN-18 R3 Guidance on Preparation of a Product Registration Submission for IVD MD” for
read more...On 26th February 2024, Singapore’s Health Sciences Authority (HSA) and the Ministry of Food and Drug Safety (MFDS)of the Republic of Korea signed a Mutual Recognition Agreement (MRA) on the
read more...In December 2023, HSA updated the following Good Distribution Practice (GDP) guides:
– GUIDANCE NOTES ON GOOD DISTRIBUTION PRACTICE
read more...In March 2020, HSA had communicated the regulatory requirement to conduct risk assessments for all therapeutic products containing chemically synthesized drug substances to identify any potential risk of nitrosamine impurities.
Where
read more...In December 2023, HSA’s Complementary Health Products Branch publishes guidance on “Procedures for Reporting of Adverse Effects, Product Defects and Product Recalls for Cosmetic Products”. The document provides guidance on
read more...Singapore’s Health Sciences Authority (HSA) regulates health products to ensure that they meet the required standards of quality, safety and efficacy. There are fees in place to help cover the
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