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Linde Gas Therapeutics
SE-181 81 Lidingo
Sweden
Phone +46 8 731 10 00
Fax +46 8 765 52 87
asklindegastherapeutics@linde-gas.com

Relevant regulations

For decades medical gases have been regarded by the healthcare community as low value commodities, delivered to the hospital and reordered when necessary. However, things are evolving rapidly. The most significant change is the classification from medical gases to pharmaceutical quality products. This process is largely driven in Europe by the regulatory authorities. This means that for medicinal gases the same requirements are applicable as for the traditional medicinal pharmaceutical industry - all for the safety of the patient. We document the quality, safety and efficacy of our gases.
 

Relevant regulations - Increasing patient safety

Gases have become an important part of modern medicine. They should be handled, prescribed and administered with the same precision and care as any other pharmaceutical.

Our focus on pharmaceutical quality control in the complete chain of events for gases, from the production facility to the administration to the patient, increases the level of patient safety in hospitals and in homecare. In documenting the toxicology and clinical aspects of our medical gases, we have followed the pharmaceutical guidelines set by the International Conference of Harmonization (ICH). In the case of traditional medicinal gases such as oxygen and nitrous oxide, our documentation summarizes existing, public domain, scientific literature according to guidelines launched by the European Medicines Agency, EMEA. With new gas enabled therapies, pre-clinical and clinical assessment follows the same development guidelines as for any new pharmaceutical compound.

As a leader in this increasingly important field, our goal is to enable healthcare professional to provide better and safer patient care when they use gas enabled therapies to treat the patients.

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