Clinical study supply disrupted by EU Regulation
New EU regulation is causing nightmarish knock on effects for clinical trial supply practitioners.
The European Union’s (EU) new clinical trial regulation coming into application in 2019, is set to revolutionize the way clinical trials operate within the EU in terms of enhanced safety and transparency requirements. These new supervision measures are being deployed through the EU portal and database.
In June 2017, the European Medicines Agency management board announced that instead of launching in October 2018 “Due to technical difficulties with the development of the IT systems, the portal’s go-live date has to be postponed [to 2019].”
This announcement, along with some of the labelling requirements, have generated frustrations within the industry.
EU labelling requirements
Companies across the whole clinical trial supply industry will have to change their labelling process in order to stay compliant. Some critics believe the requirements restrict flexibility, decreasing the amount of supplies ready to be shipped to patients and upping the amount of update handling required.
The regulation depicts Investigational Medicinal Products (IMP) be appropriately labelled to ensure the subject’s safety and the reliability of data. It requires expiry or retest dates to be printed on both primary and secondary packaging, contrarily to the current period-of-use information visible on the outer packaging.
Steve Jacobs, Chair, Global Clinical Supplies Group said: “Clinical trial regulation expects us to put expiry dating on almost everything, all the way down to primary packaging. In some cases even five milliliter vials come under consideration by some regulators.
“The key to this whole thing is that labelling requirements are a nightmare. If we actually find ourselves having to update expiry dates, we would almost have to open the clinical packaging to do it which causes a bigger nightmare from a quality perspective. Hence the focus from respondents here on cooperation between manufacturers and sponsors.
“This is going to cause a lot of smaller packaging jobs, because we can not afford to just package large quantities and then update those at sites or depots around the world, which was standard. So this is why the clinical trial regulation is something that everyone in the industry is concerned about.
“There are some serious issues with the clinical trial regulation and it would be nice if the regulators in Europe would be willing to change [aspects] before it goes into effect.”
Systems for clinical trial labelling
Labelling is a complex but integral part of supplying medicines to clinical trials around the world. The landscape is varied in terms of the systems and processes employed in designing, populating and printing labels for clinical studies (including booklets and IFUs).
To control clinical trial labelling on a global scale a number of key functions need to be managed. The three main functions are:
• Complexities around local language labelling
• Managing source data for labels, booklets and IFUs
• Customizing labels for country specific requirements
There are some compliance rulings that block the use of some labelling innovations for example the e-label which would present all the information required on scanning a barcode.
Almost a third of respondents in the Clinical Trial Supply Forum’s recent research believe semi-automated labelling could be the best fit for their company. Automation in both primary and secondary packaging can minimize errors, save time and ensure aseptic manufacturing. Any labelling changes would be made manually.
Instead of blindly pushing produced material towards sites, these methods listen to the demand and manufacture accordingly. This boosts efficiency and reduces wastage with medicines.
Just-in-time labelling has caught the eyes of many in the industry. This method speeds up the final packaging and labelling stage by part-completing the process upfront so only a small label or amendment is needed when a shipping request is received.
These systems can solve a range of complications for example with pooled studies where labels are finalized last minute, with retest or expiry date labelling after initial labelling has been done.
Bernard Jaucot, Director Strategic Solutions, Global Clinical Supplies PPD notes that just-in-time labelling systems greatly benefit larger trials that are supplying to a high amount of countries. In these cases, sponsors are likely to see less waste and more importantly have less to produce overall as the overage can be lower.
Bernard Jaucot: “Who wouldn’t be interested just-in-time labelling? The only issue I see is that often people don’t always understand what just-in- time labelling actually is and you need to in order to use it efficiently.
It has to be cleared with Quality personnel, as you want to quickly finalize the packaging & labelling without or minimal QA intervention when you get the order.”
Steve Jacobs commented: “The just-in-time labelling and on-demand supply chain concepts are really good, but they really require a paradigm shift in manufacturing for a lot of companies. Drastic changes are needed regarding quality. So companies have a quality control unit in the warehouse and other areas regarding packaging and distribution.
“It is nice to see that this is evolving.”