REGULATORY CONTROL OF MEDICINAL GASES

1. Introduction:

1.1 Medicinal gases are gases or gas mixtures intended for the administration to patients for medicinal purpose such as anaesthetic, therapeutic, prophylactic and diagnostic use.

1.2 Based on Drug Registration Guidance Document (DRGD); Appendix 2 Table I: Medical Device-Drug-Cosmetic Interphase (MDDCI) and Combination Products Classification Decision, medicinal gases are classified into two (2) categories as below:

a) Medicinal gases classified as a medicinal product / drug (regulated by Drug Control Authority (DCA)):
  • Gases or gas mixtures which mode of action is achieved primarily based on pharmacological, immunological or  metabolic action in/on the body.
b) Medicinal gases classified as medical device (regulated by Medical Device Authority (MDA)):
  • Gases or gas mixtures which mode of action is achieved primarily by physical in nature and not achieved primarily based on pharmacological, immunological or metabolic action in/on the body.

1.3 Medicinal gases classified as a medicinal product / drug (regulated by Drug Control Authority (DCA)) covers medicinal gas in cylinders intended for inhalation, which manufactured in a filling plant from bulk liquid gas for the following six (6) types of medicinal gases:
  1. Oxygen, O2 (not less than 99%v/v oxygen)
  2. Carbon dioxide, CO2 (not less than 99%v/v carbon dioxide)
  3. Nitrous oxide, N2O (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 (O2))
           *Nitric oxide, NO (Group B Scheduled Poison)

2. Implementation:

The medicinal gas industries should abide with the following implementation dates for medicinal gas products classified as medicinal product / drug:

Good Manufacturing Practice (GMP) Inspection:         starting 1st June 2021
Licensing and product registration (voluntary):            starting 1st January 2022
Licensing and product registration (mandatory):         starting 1st January 2023
 
 

Recent Updates

Additional Indications Approved
published on 2022-11-07


Voluntary Good Pharmacovigilance Practices (GVP) Inspection on Pharmaceutical Product Registration Holders (PRHs)
published on 2022-03-29


Malaysian Guidance Document on Voluntary Good Pharmacovigilance Practices (GVP) Inspection (1st Edition, March 2022)
published on 2022-03-29


Direktif untuk penggunaan Drug Registration Guidance Document (DRGD) Third Edition, Second Revision January 2022
published on 2022-01-26


Direktif untuk semua produk yang mengandungi mengandungi Mirtazapine: Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko amnesia dan Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
published on 2021-04-13


Direktif untuk semua produk yang mengandungi Rocuronium: Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan risiko Kounis Syndrome
published on 2021-04-13


Application for Section S Revision for Registered Product
published on 2019-02-19


Guidelines on Active Pharmaceutical Ingredient (API)
published on 2019-01-16


Template and Declaration Letter for API
published on 2019-01-16


Pembukaan Data Editing dan Penutupan Data Cleaning
published on 2018-12-12


Direktif untuk semua produk yang mengandungi pemetrexed: Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan nephrogenic diabetes insipidus dan renal tubular
published on 2018-12-10


Direktif untuk semua produk yang mengandungi filgrastim, pegfilgrastim dan lenograstim: Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan aortitis.
published on 2018-12-10


Direktif untuk semua produk yang mengandungi domperidone: Pengemaskinian sisip bungkusan dan risalah maklumat ubat untuk pengguna (RiMUP) dengan maklumat berkaitan interaksi ubat yang mengakibatkan peningkatan risiko QT interval prolongation.
published on 2018-12-10


National Centre for Adverse Drug Reactions Monitoring Annual Report
published on 2018-12-03


Garispanduan Pelaksanaan Risalah Maklumat Ubat Untuk Pengguna (RiMUP)
published on 2018-08-01


Product Classification Application Forms
published on 2018-08-01


Directives, Circulars & Announcements for Active Pharmaceutical Ingredient (API)
published on 2018-01-16


Arahan Pengarah Kanan Perkhidmatan Farmasi Bil. 11 Tahun 2016 - Penerimaan Pengesahan Pematuhan APB Bagi Tujuan Pendaftaran Semula Produk Farmaseutikal Berdaftar
published on 2016-07-01


Appendix 6 : Guideline On Regulatory Control Of Active Pharmaceutical Ingredients (APIs)
published on 2014-04-07


National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

 

 

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