Thai Food and Drug Administration (FDA) published new guidelines on labelling requirements for medical devices. These guidelines provide clarity on how labels should be attached to medical devices intended for
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Thai FDA Enforces New Compliance Standards for Medical Device Manufacturers and Importers
On September 6, 2024, TH FDA released and amendment of the “Ministry of Public Health Notification, RE: Standards of Medical Devices that Manufacturers or Importers must comply with, B.E. 2563
read more...Thai FDA releases Guideline for Referencing Existing documents, Document transfer, or other cases in Submitting Applications to Manufacture and Import Licensed and Notified Medical Devices without requirements of Evaluation by Experts, Government Agencies, Organizations designated by Thai Food and Drug Administration
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,
read more...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,
read more...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
read more...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
read more...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
read more...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
read more...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
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