This article describes the procedures and the requirements for submitting an SFDA registration application for medicinal gases products in Saudi Arabia.
What are Medicinal gases?
Medicinal gases are gases used in medical procedures as key components of Life-supporting systems in human beings. They are packed as a compressed gas under pressure in cylinders or liquefied gas at high or low pressure and administered to patients through designated valves or evaporation and delivery by using hospital delivery systems.
Medicinal Gas Classes
Medicinal gases are classified into two main categories as below:
- Medicinal gases as a medicinal drug product.
- Medicinal gases as a medical device
Medicinal Gases as a Drug
Registration of medicinal (pharmaceutical) gases in Saudi Arabia will be applicable starting from 2022 in three stages as follows:
|SFDA registration||– Drug Track and Trace System for pharmaceutical products (RSD)|
– Pharmacovigilance system
|First stage(Starting in 2022)||Voluntary||Voluntary|
|The second stage (Starting in 2023)||Mandatory||Voluntary|
|Third stage (Starting in 2024)||Mandatory||Mandatory|
Medicinal gases that have the following medical claims will be registered under the Drug sector as Generic products.
|Gas Name||Gas Status||Indication|
|Oxygen (O2)||Liquid||Restore tissue oxygen tension by improving oxygen availability in a wide range of conditions such as COPD, cyanosis, shock, severe haemorrhage, carbon monoxide poisoning, major trauma, and cardiac/respiratory arrest. Aid Resuscitation. Provide Life support for artificially ventilated patients. Aid Cardiovascular stability. Treatment or prevention of acute or chronic hypoxemia, irrespective of genesis. As part of the fresh gas supply in anaesthesia or intensive care. As the driving gas in nebulization therapy. As first aid treatment with 100% oxygen in decompression accidents, and suspected- carbon monoxide poisoning. Under hyperbaric pressure is used for treatment of conditions where it is beneficial to increase the oxygen content of blood and other tissues above which is attainable under norm baric pressure. Treatment of decompression sickness, air/gas emboli of another genesis.|
|Oxygen (O2)||Compressed||Restore tissue oxygen tension by improving oxygen availability in a wide range conditions such as COPD, cyanosis, shock, severe haemorrhage, carbon monoxide poisoning, major trauma, and cardiac/respiratory arrest. Aid Resuscitation. Aid Cardiovascular stability. Treatment or prevention of acute or chronic hypoxemia, irrespective of genesis. As part of the fresh gas supply in anaesthesia or intensive care. As the driving gas in nebulization therapy. As first aid treatment with 100% oxygen in decompression accidents, and suspected carbon monoxide poisoning Under hyperbaric pressure is used for the treatment of conditions where it is beneficial to increase the oxygen content of blood and other tissues above which is attainable under norm baric pressure Treatment of decompression sickness, air/gas emboli of another genesis.|
|Nitrogen (N2)||Compressed||Gas mixture for lung function test|
|Carbon Dioxide (CO2)||Compressed||Respiratory stimulation during and after anaesthesia|
|Nitrous Oxide (N2O)||Compressed||Used extensively in a wide range of surgical procedures for both analgesia and anaesthesia. For the treatment of short-term pain conditions of mild to moderate intensity when rapid analgesic onset and offset effects are wanted. As an anesthetic agent, for use in combination with any other anesthetic agent administered intravenously or by inhalation.|
|Synthetic Air||Compressed||As a replacement for ordinary ambient/atmospheric air whenever it is needed e.g.: during ventilatory therapy and/or in anesthesia, As part of the fresh gas flow e.g.: combined with oxygen in order to achieve a desired inspired oxygen fraction. As source of clean air for immuno-suppressed patients e.g.: post organ/cell transplants or severe burns As a carrier gas for anaesthetic agents. Driving ventilators and incubators, where it provides uncontaminated and controlled air flows helping to reduce the high concentration of oxygen exposure.|
|Medical Air||Compressed||As a replacement for ordinary ambient/atmospheric air whenever it is needed e.g.: during ventilatory therapy and/or in anesthesia, As part of the fresh gas flow e.g.: combined with oxygen in order to achieve a desired inspired oxygen fraction. As a source of clean air for immuno-suppressed patients e.g.: post organ/cell transplants or severe burns. As a carrier gas for anaesthetic agents Driving ventilators and incubators, where it provides uncontaminated and controlled air flows helping to reduce high concentration of oxygen exposure.|
|Nitric Oxide (NO) / Nitrogen (N2) mixture||Compressed||The therapeutic use of inhaled nitric oxide is based on its ability to achieve potent and sustained pulmonary vasodilation without significantly decreasing systemic vascular tone. It is produced in mixtures with Nitrogen N2 at different concentrations: 250 ppm, 450 ppm, 800 ppm, 900 ppm In conjunction with ventilatory support and other appropriate active substances, is indicated: For the treatment of newborn infants 34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation. As part of the treatment of peri- and postoperative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction with heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation|
|Nitrous Oxide (N2O) / Oxygen (O2) mixture||Compressed||Provides the pain-relieving properties of nitrous oxide with the benefits of additional oxygen without producing unconsciousness. It is a widely used analgesic for acute, short term pain relief in a diverse range of clinical situations, from painful procedures to childbirth. For the treatment of short-term pain conditions of mild to moderate intensity when rapid analgesic onset and offset effects are wanted. It is an analgesic with a very rapid onset of action and is quickly eliminated from the body. It is widely used by midwives, hospitals and the ambulance service. It is used exclusively for short-term procedures inevitably involving pain, including (but not limited to): – Acute Trauma – Tooth extraction and other brief procedures in dental works – wound and burn dressing, wound debridement and suturing – fracture and joint manipulation – Colonoscopy – Venopuncture – Labour.|
|Helium (He) / Oxygen (O2) mixture||Compressed||Helium is often used to treat fixed partial upper airway obstructions or increased air resistance. This will help patients breathe easier. Indicated to assist flow of oxygen into the alveoli and to reduce the work of breathing in patients with severe airway obstruction (upper or lower). Can be used for nebulization therapy as the driving gas for generation of aerosol and as the carrier gas for inhalation of aerosol.|
|Carbon Dioxide (CO2) / Oxygen (O2) mixture||Compressed||For extracorporeal circulation (CEC) Carbon Dioxide /Oxygen Medical Gas Mixture is used to stimulate respiration after a period of apnea and in the management of chronic respiratory obstruction after the obstruction has been removed. For stimulation of spontaneous respiration during normobaric administration of oxygen, e.g. for emergency treatment of CO-intoxication or for prevention of hypocapnia in hyperventilation.|
Route of registration
SFDA registration of Medicinal gases will be through the Saudi Drug Registration system (eSDR). The file structure will be as the usual SFDA drug registration requirements.
Medicinal Gases Registration Requirments
Module 1: the below requirements from module 1.
|Module 1||Regional Administrative Information|
|1.1||Table of content|
|1.3.1||Summary of Product Characteristics (SPC)|
|1.3.3||Patient information leaflet (PIL)|
|1.7||Certificates and documents|
|1.7.2||CPP or Free-sales|
|1.7.3||Certificate of analysis – drug substance / finished product|
|1.7.7||Certificate of suitability for TSE|
|1.7.10||Letter of access or acknowledgement to DMF|
|1.9||Response to questions|
Module 3: the below requirements from module 3.
|3.2.S||Drug Substance For S part, current European, British or US Pharmacopoeia monographs and guidelines should be taken into account.|
|3.2.P.1||Description and composition of the drug product|
|3.2.P.3.5||Process validation and/or evaluation|
|3.2.P.5||Control of drug product|
|3.2.P.7||Container / closure system|
Medicinal gases must comply with:
- SFDA GMP: Guide to Good Manufacturing Practice for Medicinal Products and related Annexes (Annex 6).
- The GCC Guidance for Presenting the SPC, PIL, and Labeling Information.
Medicinal gases classified as medical devices
Gases or gas mixtures that are used to operate or sterilize medical devices and supplies or that are used for the treatment or diagnosis and do not cause any pharmacological, immunological, or metabolic action to achieve the primary purpose of their use.
- Accessories during use fall under the definition of a medical device and are subject to the requirements of the medical devices sector
- Gases that are manufactured or produced in the hospitals.
- Cylinders on their own (empty cylinders).
Note: Gas cylinders must comply with the national standards (SFDA.MD /ISO 32:2017).
|Gas/gas mixture for medical use||Shoulder colour||RAL number|
|Medical air/Synthetic air||White/Black||9010/9005|
|Nitric Oxide/Nitrogen||Turkish Blue if NO <=1000 ppm (VN)||5018|