Malaysia NPRA Strengthens Regulatory Control of Medicinal Gases Classified as Drugs

Malaysia NPRA issues 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. 

To ensure the product is safe, of quality and efficacious, strengthening the implementation of the regulatory control to the medical gas products that are classified as drugs are as follows:          

  • GMP inspection 
  • licensing and registration of medical gas in cylinder 

The scope of control is for the following six (6) types of gases:                   

  1. Oxygen, 02 (not less than 99%v/v oxygen)                  
  2. Carbon dioxide, C02 (not less than 99%v/v carbon dioxide)                  
  3. Nitrous oxide, N20 (not less than 98%v/v nitrous oxide)                  
  4. *Nitric oxide, NO (not less than 99%v/v nitric oxide)                  
  5. Nitrous oxide/oxygen mixture (50: 50%)                  
  6. Medical air (oxygen/nitrogen mixture; 19.5 – 23.5%v/v of oxygen (02))                   

*Nitric oxide, NO (Group B Scheduled Poison) 

The following gases are outside the scope of this implementation:                   

  1. Gases classified as medical devices              
  2. Gases that are manufactured, mixed and handled (including extemporaneous preparation) in hospitals for own patients use            
  3. Gases for animal use (veterinary)  
  4. Gases use for cosmetic/aesthetic purpose              
  5. Gases use in laboratory (e.g., gases for freezing of tissue samples, calibration gases)          
  6. Recreational gases (e.g., oxygen gases for diving, mountain climbing)      

The procedures and requirements for registration of the product gas medicine is similar to that of the pharmaceutical products. Requirements for registration that are specific for medicinal gas is detailed in the Guideline on Registration of Medicinal Gases. 

Effective date for this implementation: 

  • GMP inspection: starting June 1, 2021 
  • Product licensing and registration (voluntary): starting January 1, 2022  
  • Product licensing and registration (mandatory): starting January 1, 2023 

More details are found on the Malaysian NPRA website:—Produk-Gas-Perubatan-Dan-Penggunaan-Guideline-On-Registration-Of-Medicinal-Gases.pdf/ 

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