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
Regulatory News
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
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 drug substances to identify any potential risk of nitrosamine impurities.
Where
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 Product Recalls for Cosmetic Products”. The document provides guidance on
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 efficacy. There are fees in place to help cover the
WHO: Singapore HSA, Korea MFDS, and Switzerland Swissmedic are the first three countries to be listed as WHO-Listed Authorities (WLA)
Korea MFDS, Singapore HSA and Switzerland Swissmedic are the first 3 countries to be listed as WHO-Listed Authorities (WLA).
This marks a significant milestone for the 3 countries that have been
Minister of Finance of Vietnam Promulgates Circular Prescribing Fees in Medical Device Sector
Circular 59/2023/TT-BTC introduces regulations on fees in medical sector, and the collection, transfer, management and use thereof. Such fees in the medical sector include:
a) Fees for processing of applications for