Navigating the regulatory landscape for controlled substances

Controlled substances hold considerable potential as an alternative to opioids for use as painkillers and treatments for certain disorders. However, the regulatory requirements modulating controlled substance manufacturing, analysis, transport, import, and export are complex and challenging to navigate due to their tendency to be used for recreational use. 

As the sector’s understanding increases, more and more companies are seeing potential in the use of controlled substances for a new generation of painkillers.

Controlled substances are becoming increasingly highly prized as active pharmaceutical ingredients (APIs) for a key reason. Regulated substances, such as cannabinoids and hallucinogens, have been used for hundreds of years in folk medicine to manage pain as well as a wide range of other conditions

However, now the pharma industry’s work to find solutions to treat and mitigate the abuse and addiction to opiate-derived pain killers is leading to a maturation in its understanding of the biological mechanisms involved in drug intoxication. 

In an article with Speciality Chemicals, Gianluca Franguelli, Vice President, Drug Substance Development explores the complex regulatory environment for handling controlled substances.

You can read the full article by clicking here on page 28.