PUTRAJAYA, Dec 11 — Medical gas products must be licenced and registered from January 1, 2023, to ensure products supplied to patients and consumers are of quality as well as safe and effective.
Health director-general Datuk Dr Muhammad Radzi Abu Hassan, in a statement today, said medical gas is used in treating certain diseases or medical conditions as well as for anaesthesia and diagnostic purposes.
In relation to this, the Health Ministry (MOH), through the National Pharmaceutical Regulatory Agency (NPRA), expanded the scope of regulatory control to include medicinal gas products, and the Guidelines on Registration of Medicinal Gases were also issued in 2021.
“The NPRA is also responsible for conducting inspections on local medical gas manufacturers to ensure the manufacturers comply with the Good Manufacturing Practice (GMP) standards for pharmaceutical products,” he said.
Dr Muhammad Radzi said that inspections of 12 medical gas manufacturers had been carried out and revealed that they meet the standards for continuous production of quality medical gas.
“These manufacturers have also submitted registration applications for their medical gas products produced to the NPRA according to the guidelines issued,” he said.
Dr Muhammad Radzi said the Drug Control Authority (PBKD), in its 391st meeting on December 7, agreed to register the first medical gas, which is Linde Medicinal Water, 100 per cent v/v based on the product evaluation report presented.
The registration holder of the product is Linde Malaysia Sdn Bhd, and it is manufactured by Linde Gas Products Malaysia Sdn Bhd in Selangor and Linde EOX Sdn Bhd in Kuching, Sarawak.
“The NPRA is also evaluating several more registration applications that have been submitted by medical gas distribution companies for local use so that they can be registered in the near future,” he said.
He said the NPRA will continue to monitor and ensure the registration of medical gas products, especially oxygen, carbon dioxide, nitrous oxide (single or mixed with oxygen), nitric oxide, and other medical grade gas in cylinders, runs smoothly so that the supply and patient access to gas medicine is not affected.
“The MOH, through the NPRA, is committed to continue its efforts to improve regulatory control of medicines and cosmetics from time to time to ensure the well-being of the people,” he added.
— Bernama
