A medical or medicinal gas is defined as any gas or mixture of gases intended for the administration to patients for anaesthetic, therapeutic, diagnostic, or prophylactic medicinal purposes. They include common medicinal gases like Oxygen, Carbon dioxide, Nitrogen, Helium and Nitrous oxide.
The National Pharmaceutical Regulatory Agency (NPRA) Malaysia has categorized medicinal gases as:
- A medicinal product/drug (under DCA), where the mode of action is achieved primarily based on the pharmacological, immunological, or metabolic action in/on the body.
- A medical device (under Medical Device Agency, MDA), where the mode of action is primarily by physical nature and not achieved predominantly based on the pharmacological, immunological, or metabolic action.
As medicinal gases are drugs as per Section 2, SODA 1952, they are regulated by the Drug Control Authority (DCA) and all the Regulatory frameworks pertaining to the manufacturing, authorization and marketing of drugs are applicable to medicinal gases as well.
NPRA issued 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.
The scope is for the following six (6) types of gases:
- Oxygen, 02 (not less than 99%v/v oxygen)
- Carbon dioxide, C02 (not less than 99%v/v carbon dioxide)
- Nitrous oxide, N20 (not less than 98%v/v nitrous oxide)
- Nitric oxide, NO (not less than 99%v/v nitric oxide) [Nitric oxide, NO (Group B Scheduled Poison)]
- Nitrous oxide/oxygen mixture (50: 50%)
- Medical air (oxygen/nitrogen mixture; 19.5 – 23.5%v/v of oxygen (02))
The effective dates of implementation are:
- GMP inspection: starting June 1, 2021
- Product licensing and registration (voluntary): starting January 1, 2022
- Product licensing and registration (mandatory): starting January 1, 2023
With the above information, it is clear that the manufacturers of medicinal gases must abide by the Malaysian Regulatory jurisdiction in order to have a successful market-entry. To know more about the jurisdiction of Medicinal gases in Malaysia, reach out to Freyr.