Starting from Jan 1, 2023, the licensing and registration of medical gas products will be mandatory in order to guarantee the quality, safety, and effectiveness of products provided to patients and consumers, revealed Health director-general Datuk Dr Muhammad Radzi Abu Hassan in a statement on Monday (Dec 11).
Dr Muhammad Radzi emphasized the importance of this move, stating that medical gas is utilized in the treatment of specific diseases or medical conditions, as well as for anesthesia and diagnostic purposes.
He further explained that the National Pharmaceutical Regulatory Agency (NPRA) under the Health Ministry is expanding its regulatory control to include medicinal gas products, and Guidelines on Registration of Medicinal Gases have been issued in 2021 to ensure compliance.
Additionally, the NPRA is conducting inspections on local medical gas manufacturers to ensure adherence to the Good Manufacturing Practice (GMP) standards for pharmaceutical products, with inspections of 12 manufacturers already carried out, showing compliance with the set standards for the continuous production of quality medical gas.
Dr Muhammad Radzi also mentioned that the Drug Control Authority (PBKD) recently agreed to register the first medical gas, Linde Medicinal Water 100% v/v, during its 391st meeting on Dec 7, based on the product evaluation report presented.
Linde Malaysia Sdn Bhd is the registration holder of the product, which is manufactured by Linde Gas Products Malaysia Sdn Bhd in Selangor and Linde EOX Sdn Bhd in Kuching, Sarawak.
Moreover, the NPRA is currently evaluating several registration applications submitted by medical gas distribution companies for local use, with the aim of registering them in the near future, while continuing to monitor and ensure the smooth registration of medical gas products.
Dr Muhammad Radzi affirmed the commitment of the NPRA and the health ministry to continually improve regulatory control of medicines and cosmetics to safeguard the well-being of the people. – Bernama
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