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
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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,
read more...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)
NPRA Malaysia Publishes Updates on Guidance and Requirements on Conditional Registration of Pharmaceutical Products During Disaster
National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued the third revised version of the guidance and requirements on conditional registration of pharmaceutical products during disaster in March 2022.
The objectives of
read more...Hong Kong Drug Office Publishes Guideline on Pharmaceutical Products Recall
Hong Kong Drug Office has published some guidelines on the recall of pharmaceutical products in March 2022.
Pharmaceutical products are subjected to a recall when there is suspicion on the potential
Singapore HSA Announces Requirement for Notification of Lot Release Information of Imported Vaccines
The Health Sciences Authority (HSA) Singapore has published an update regarding the notification of lot release information of imported registered vaccines before they are supplied to Singapore, and this information
read more...Australia TGA Publishes Latest Guidance on Reclassification of Active Implantable Medical Devices
The Therapeutic Goods Administration (TGA) Australia has published the latest document on the reclassification of active implantable medical devices (AIMD) with information on transitional arrangements and obligations, in March 2022.
Active
NPRA Malaysia Publishes Frequently Asked Questions on Medicinal Gases
National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued a set of frequently asked questions (FAQs) on medicinal gases in February 2022.
The document provides detailed information on the questions and answers
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