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
read more...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
read more...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...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
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)
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 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
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...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
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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