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 regarding these points: General information, Registration, Good Manufacturing Practice (GMP) requirements and Pharmacovigilance (PV).
Under general topics, the scope of the regulation for medicinal gases is discussed in detail. Some examples of medicinal gas that is considered as a medicinal product or drug is oxygen, carbon dioxide and medical air.
The registration of medicinal gas products can currently be done voluntarily (from 1st January 2022). It will be mandatory to register these products from 1st January 2023 onwards.
As for the GMP requirements, manufacturers are expected to adhere to the PIC/S Guide to Good Manufacturing Practice for Medicinal Products and any related Annexes.
Regarding PV requirements for these products, Adverse Drug Reactions (ADRs) need to be reported to NPRA.
More details can be found in “Medicinal Gas: Frequently Asked Question (FAQs), February 2022”: https://npra.gov.my/easyarticles/images/users/1061/Medicinal-Gas-FAQ.pdf