The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has issued the second version of the guideline on the regulation of therapeutic products in February 2022, and the document
Regulatory News
Singapore HSA Publishes Regulatory Updates for Therapeutic Product Registration
The Health Sciences Authority (HSA) Singapore has provided a list of the latest regulatory updates for therapeutic product registration in April 2022.
The changes include revised checklists for post-approval minor variations,
Singapore HSA Publishes Guidelines on Safety of Ingredients for Traditional Medicines and Health Supplements
The Health Sciences Authority (HSA) Singapore has published the first version of the guidelines on the establishment of ingredients’ safety for traditional medicines (TM) and health supplements (HS) in March
Australia TGA Publishes Latest Guidance on Medical Device Patient Information Leaflets and Implant Cards
The Therapeutic Goods Administration (TGA) Australia has published the latest version of the guidance document on patient information materials (patient implant cards and patient information leaflets) in March 2022.
One notable
Singapore HSA Publishes Guidelines for Manufacturing Standards of Traditional Medicines and Health Supplements
The Health Sciences Authority (HSA) Singapore has published the first version of the guidelines on manufacturing standards of traditional medicines (TM) and health supplements (HS) in March 2022.
Manufacturers are required
NPRA Malaysia Publishes Guide on Voluntary Good Pharmacovigilance Practices (GVP) Inspection
The National Pharmaceutical Regulatory Agency (NPRA) Malaysia has published the first edition of the “Malaysian Guidance Document on Voluntary Good Pharmacovigilance Practices (GVP) Inspection” in March 2022.
The objective of this
Singapore HSA Publishes Latest Guidance on Special Access Routes
The Health Sciences Authority (HSA) Singapore has published the latest guidance document on special access routes (SAR), that provide a pathway for unregistered medical devices to be brought into Singapore,
Singapore HSA Publishes Guidelines on Labelling Standards of Traditional Medicines and Health Supplements
The Health Sciences Authority (HSA) Singapore has published some guidelines regarding the labelling standards of traditional medicines (TM) and health supplements (HS) in March 2022.
The objective of these guidelines is
Australia TGA Publishes Information on Manufacture of Medical Devices
The Therapeutic Goods Administration (TGA) Australia has published some information regarding the manufacture of medical devices pertaining to quality management in March 2022.
Medical devices and in vitro diagnostic products (IVDs)