New EU clinical trial regulations will pass into law in 2016. For clinical trial logistics, it is always important to plan the distribution strategy at the same time as planning the packaging – and with the upcoming legislation, companies should consider options that minimise the need for expiry updating of clinical trial material. Catalent Pharma Solutions’ Esther Sadler-Williams offers her personal thoughts on the matter.
Tell us more about the new EU clinical trial regulations due to pass into law next year.
This new regulation collates all current Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) regulations into one, and should become effective in May 2016 – but this date is dependent on the availability of an electronic portal that manages clinical trial submissions/communications between sponsors and member states. There are transition periods for ongoing studies. The changes that the new regulation brings may have a substantial impact on the packaging and labelling of clinical trial supplies; re-test/expiry dates will be needed on each level of packaging.
How will these regulations affect the logistics sector?
Today, re-test/expiry dates do not need to be on every level of clinical trial medication packaging (kit), or can even be omitted if they can be controlled by electronic means. After these regulations come into force, expiry updating at regional or local depots may be required more often. Thus, these depots must have the capability and be licensed to do this. In some circumstances, if expiry date updates are not possible locally, kits may need to be transported back to a region where this process can be managed, which may result in import/export challenges.
Could this have a knock-on effect on the trials themselves?
This regulation may bring efficiencies: predictability (lower potential for divergent requirements for clinical trial authorisations) with limited impact to overall submission assessment timelines; and a single approval for the clinical trial rather than approval in each member state. However, the changes regarding re-test/expiry dates may provide logistical challenges; if local update is not possible, or considered ‘unsafe’, new batches of clinical trial medication with the updated re-test/expiry dates may need to be manufactured, which can increase costs and potentially compromise timelines for re-supplies. In addition, ‘seeding supplies’ at potentially low recruiting sites may be a challenge.
Why is it important for companies to consider their distribution strategy alongside their packaging requirements?
During the planning process for a clinical trial protocol, most studies are managed using an interactive voice/web response system that requests appropriate patient kits automatically, and it may also manage the randomisation process. It is important that the way in which kits are packed and labelled is in alignment with how they are going to be requested, such as kit number ranges (country specific or single randomisation strategies). It would also be inappropriate to pack patient kits into a shippable unit of four if they will later be requested singly. Any regional or local depots involved in the supply chain must be identified and included in the set-up for the supply chain and interactive response technology system.
How can the need for expiry updating of clinical trial material be minimised?
An innovative approach is to package the clinical trial medication as close as possible to the time and place where it is to be dispensed to the patient. This way, the current re-test/expiry date can be added to the clinical label that is applied to the kit. At Catalent, we call this a demand-led service process: we have primary packaged material at regional GMP distribution facilities; we forecast appropriate regional requirements for a certain time period; and, based on this forecast, we then secondary package, release and ship to the required clinical sites in that region. This has a very positive effect in reducing waste and securing continuity of supply for the important end user – the patient.
Can pharma and logistics companies work together to overcome some of the issues?
Logistics providers are key to pharma being able to offer a successful supply chain. They are the experts in import and export requirements and can support in some of the new patient-centric offerings – where clinical trial medication is delivered directly to the patient’s home rather than to the clinical site.
In addition, logistics companies can support the supply chain of tomorrow through the provision of innovative technology for tracking or cool chain management.
Join Esther Sadler-Williams at the FlyPharma Conference 2015, and learn more about this topic in her session Clinical Trial Logistics: A Different Perspective on the Supply Chain. Book your two-day pass now and meet all our distinguished speakers at this September’s event.
This content is provided for information purposes only, and is not intended as legal advice. Readers are encouraged to seek the advice of his/her own legal counsel with regard to the impact of any regulations on their business.
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