As part of HSA’s ongoing initiative to improve regulatory efficiency and enhance clarity in Singapore’s regulatory requirements and processes, HSA updates Main Guidance on Therapeutic Product Registration and Appendices (with
Regulatory News
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 of a Refuse-to-File (RTF) mechanism for initial pharmaceutical product registration
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 Therapy Products. The updates mainly involved the following aspects:
Risk
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) Edition 8.0, slated for publication on April 30, 2024.
This decision
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 Registration in Singapore”. The guidance has been updated to include
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 the NPRA in pharmaceutical product registration.
The following information has been
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 Preparation of a Product Registration Submission for IVD MD” for
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 of Korea signed a Mutual Recognition Agreement (MRA) on the
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