Navigating the regulatory landscape for controlled substances
Gianluca Franguelli , vice president of drug substance development at Recipharm , explores the complex regulatory environment for handling controlled substances in pharmaceutical development and advises how to maintain legislative compliance in order to ensure project success
Controlled substances are chemicals whose manufacture , possession or use are highly regulated by national governments and local authorities , due to their tendency to be abused as recreational drugs . They include several classes of chemical , such as opioids , hallucinogens and cannabinoids . The global controlled substance market was valued at $ 64 billion in 2018 and is expected to expand at a CAGR of 7 % through to 2027 . 1 They are becoming increasingly highly prized as APIs for a key reason . Regulated substances , such as cannabinoids and hallucinogens , have been used for hundreds , if not thousands , of years in folk medicine to manage pain and many other conditions . Now , the pharmaceutical industry ’ s work to find ways to treat and mitigate the abuse of and addiction to opiatederived painkillers is leading to a maturation in its understanding of the biological mechanisms involved in drug intoxication . As the sector ’ s understanding increases , more and more companies are seeing potential in the use of non-opioid controlled substances for a new generation of painkillers , as well as treatments for ADHD , hormonal disorders and sleep disorders . However , to achieve this requires handleingthem safely and in a manner that complies with stringent regulations . Failure to do so could leave pharmaceutical companies vulnerable to fines and sanctions from regulatory authorities .
Regulatory landscape
The international legislative environment for handling controlled substances in pharmaceutical production is highly complex and varies from market to market . In the UK , for example , Home Office regulations require robust and secure facilities during the manufacture of any controlled substance . Strong procedural systems and trained , knowledgeable , reliable employees are needed to ensure compliance . Import licences are also required each time an order for a controlled substance is received . Further afield in Israel , the regulatory landscape of all controlled substances affects different levels from production to final user . For growing plants , research , analysis , production , transport , import and export of regulated substances and cannabinoids , permits are required from the Ministry of Health and the local police department . Cannabinoids , both plant-derived and synthetically produced , are further regulated by a special unit of the Ministry of Health . To receive these permits , a CDMO must be able to demonstrate a secure and controlled work environment , worker safety , that its workers do not have criminal records , and either GMP or GLP . For research performed in drug development and / or production , the company has to present and receive approval of the research plan in all stages
Compliant transport
The steps that need to be taken to ensure compliance vary depending on the market you are operating in at the time . However , there are commonalities between the different markets . For example , import licence are required from the relevant local body or bodies each time an order for a controlled substance is made and received . It is crucial to apply for these in good time to ensure that they are ready to be sent to the exporter as early as possible , so that the exporter can apply to their relevant local body for an export licence . Import licence time frames differ from country to country and an early knowledge of the local regulations is essential . The system for exporting the controlled substance – or formulation , or finished drug product containing one – after processing is the same in reverse . Given the fact that the granting of export licences depends on first receiving import permits , it is crucial to maintain a close working relationship with both suppliers and customers , benefiting from their understanding of the local regulatory requirements .
28 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981