Malaysia NPRA Strengthens Regulatory Control of Medicinal Gases Classified as Drugs
Malaysia NPRA issues Directive 8 of 2021 on Strengthening of the Implementation of Products Regulatory Control – Medical Gas Products …
Australia TGA Releases New Standard for Medicines with Data Matrix Codes or Serialisation
A new standard clarifying requirements for serialisation and data matrix codes on medicines supplied in Australia commences on 1 January …
Australia TGA Changes ARTG Inclusion Process for Class 1 IVD Medical Devices
On 4 December 2020, the TGA inclusion process for Class 1 in vitro diagnostic (IVD) medical devices in the Australian …
Singapore Health Sciences Authority Updates the Guidance for Product Defect Reporting and Recall Procedures for Therapeutic Products and Cells, Tissue and Gene Therapy Products
Singapore Health Sciences Authority has updated the Guidance for Industry: Product Defect Reporting and Recall Procedures for Therapeutic Products and …
Australia TGA Published Regulatory Changes for Software Based Medical Devices
Australia TGA published a summary of regulatory changes to the regulation of software-based medical devices (including software as a medical …
Singapore Implements New Regulations for Cell, Tissue, and Gene Therapy Products (CTGTP)
Singapore implements new regulations for cell, tissue, and gene therapy products (CTGTP). The regulations take effect from 1 March 2021. …
Philippines FDA Issues Implementation Schedule and Guidelines on Standards for Medical Devices
The Philippines FDA issued Circular no. 2021-002 on 4th January 2021, which contains the implementation schedule of the Administrative Order …
Vietnam MOH Issues Official Letter to Guide the Preparation of Applications for Medical Device Registration
The letter states that the Ministry of Health has received, processed, and appraised applications for medical device registration and in …
CDE of China Issues Guidelines for Drug Information Changes
The Center for Drug Evaluation (CDE) released the “Marketed Chemicals Pharmaceutical Changes Study Technical Guidelines (Trial)”, “Marketed Chemicals and Biological …