A joint commitment to brand excellence
Let’s talk about something in the pharmaceutical drug naming world that will impact us all: the recent interested parties meeting held by the European Medicines Agency’s (EMA) Name Review Group (NRG). The NRG discussed revisions to their guideline for naming human medicinal products, which had been in draft form since December 2021.
In our promise to act as the bridge between the NRG and our clients, we’re here to highlight key takeaways from the meeting and how they will affect your future brand/name development projects.
- Naming objections due to difficulties in pronunciation:
Since the NRG must consider multiple languages when reviewing names, if difficult pronunciation can lead to misidentification of a drug product, there may be an objection. They did note a decrease in company submissions of these types of problematic names, down from a peak in 2021.
- Increased stringency of application on the International Nonproprietary Names (INN) 50% rule: To comply with the WHO resolution on protection of INNs and INN stems, the length and location of letter strings that are common between a nonproprietary name and a proposed invented name will be considered by the NRG when reviewing names. A decision tree and some examples of acceptable and objectionable proposals were shared with the group.
- They changed the validity of period of names: The NRG noted that they will still review two name proposals at a time but made changes to the time period that a conditionally approved name will remain valid in their database. Currently, names are valid for three years, with an option to renew once for an additional three years. Based on the low number of requests for reconfirmation, the updated guideline will allow for a one-year extension following the initial three-year validity period.
But there’s more: The NRG revealed another part of their process that aligns with our commitment to safety: They confirmed that they have been experimenting with using POCA, a tidbit that has long been speculated. And like many of us, while we’ve integrated POCA into our process, we know it is not the end-all-be-all—we must incorporate human insight and consider how non-name characteristics and other clinical factors contribute to medication errors.
On the linguistic and product context front, they shared a real-world example where a proposed invented brand name for a breast cancer drug was the same as a milk product in a certain country. If they had solely relied on POCA as a measure of acceptability, they might have ended up with an offensive name in a few cultures. We appreciate how seriously they take their job!
Delivering excellence amongst an ever-expanding landscape
As the naming landscape gets busier, these case-by-case reviews are getting tougher. But the NRG is staying ahead with an AI-driven tool.
Although we don’t know all the details about the tool yet, it’s encouraging that we are all innovating and aligning on how to better use technology and improve upon processes to ensure excellent brands, even in tricky situations.
In fact, we are developing a new proprietary AI to stay ahead of the curve as well. It specializes in brand creation, employing advanced phonetic, orthographic and various analytical methods to align brand identity with competitive intelligence insights. Interested in learning how we will leverage AI to optimize your next branding project all while you continue to focus on creating effective drugs for patients? Contact our team today.