Malaysia NPRA issues Directive 8 of 2021 on Strengthening of the Implementation of Products Regulatory Control – Medical Gas Products and the Use of Guideline on Registration of Medicinal Gases.
To
Regulatory News
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 2023. The Therapeutic Goods (Medicines – Standard for Serialisation and
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 Register of Therapeutic Goods (ARTG) changed. This follows similar changes
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 Cells, Tissue and Gene Therapy Products (CTGTPs). The main updates
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 device – SaMD) that take effect from 25 February 2021.
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.
According to the Health Products (Cell, Tissue, and Gene Therapy Products)
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 No 2018-002: “Guidelines Governing the Issuance of an Authorization for
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 order for applicants to understand and comply with regulations properly
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 Products Clinical Changes Technical Guidelines”, and “Chemicals Changes Acceptance and