On September 6, 2024, Thai FDA released and amended the “Ministry of Public Health Notification, Re: Standards of Medical Devices that Manufacturers or Importers must comply with, B.E. 2563 (2020)”
The
Regulatory News
Thai FDA issues guidelines on referencing existing documents, document transfer, and other cases for manufacturing and importing licensed and notified medical devices without agency evaluation
On September 19, 2024, Thai FDA releases the guidelines for submitting applications to manufacture and import Licensed and Notified Medical Devices on the condition that referencing existing documents, document transfer,
Singapore HSA Implements Testing of Diethylene Glycol and Ethylene Glycol for Health Supplement and Traditional Medicines
Following World Health Organization (WHO) Alert regarding identified batches of falsified and fraudulently mislabelled drums of DOW USP/EP Propylene Glycol, which were found to contain unacceptable levels of ethylene glycol,
Malaysia NPRA updates on Procedure and Criteria for Extending the Validity Period of the Bioequivalence Study Center (BE) and Ethics Committee registered with Drug Control Authority (DCA)
Based on current guidelines of BE study center inspections, BE study centers that have been inspected with satisfactory inspection results will be listed in NPRA BE Study Center Compliance Program
Singapore HSA Releases eCTD Specification Package for Implementation
“Singapore HSA’s Therapeutic Product Branch (TPB) is pleased to announce the release of the SG-HSA Specification version 1.0 package, effective 25 September 2024. The eCTD Specification package version 1.0 is
Singapore HSA Updates Guidance for Post-Marketing Vigilance Requirements for Therapeutic Products & CTGTP
“On 7th Oct 2024, Singapore HSA updated Guidance for Post-Marketing Vigilance Requirements for Therapeutic Products & Cell, Tissue and Gene Therapy Products. The changes are summarised as below:
– Removed fax
Singapore HSA Updates Guidance Documents for CTGTP
In September/October 2024, HSA has re-organized and updated Cell, Tissue or Gene Therapy Product (CTGTP) guidance on Product Notification, Product Registration and Variation Application.
To view the updated guidance, please visit
FDA Philippines Publishes General Rules and Regulations on the Registration of Pharmaceutical Products and Active Pharmaceutical Ingredients Intended for Human Use
Administrative Order 2024-0013 establishes updated rules for the registration of pharmaceutical products and Active Pharmaceutical Ingredients (APIs) for human use, aligning with regional and global regulatory harmonization efforts. The Order
Singapore HSA Updates Webpage on Nitrosamine Impurities in Medicines
Singapore Health Sciences Authority (HSA) has updated the webpages on nitrosamine impurities in medicines.
The main webpage provides general information on the background and the regulatory approach on the nitrosamine impurities