For those individuals and companies invited to attend the European Medicines Agency Name Review Group (EMA NRG) joint meetings, we are given the first chance to receive news from the organisation in regards to regulatory guidance and key points of emphasis for name reviews.

As I sat in the room with my fellow invitees and heard the announcement that - as part of a pilot programme to improve effectiveness of the name review process and rationalise the work load - the EMA NRG cancelled the scheduled July meeting, reduced future meetings from six per year to four, and instituted a cap of 90 or so name submissions for review at each meeting, my thoughts turned immediately to the widespread impact this would have for those both with names nearing submission and for those who are about to begin their name development journey.

Time is of the essence. Names are accepted in principle on a first-come, first-served basis with priority applied to ongoing initial marketing authorisation applications and although the submission deadline has passed for the next review meeting on 20 September, interested parties have until 29 September to submit names for the review meeting scheduled for 22 November.

In addition to the changes in the review schedule, attendees were given an insight into how the EMA NRG is reviewing names, which represents a shift in the way companies should approach submitting names to the agency. At Addison Whitney, a global branding firm specialising in pharmaceutical naming and brand development, we keep it as a top priority to maintain current knowledge of global regulations and how it impacts your asset, so it is always best to first consult with a branding firm when developing a name for submission to ensure you’re getting the most current guidance. Based on my gained insight after leaving the meeting, here are my top recommendations to consider when submitting a name for review with the EMA.

1. Conduct full regulatory research studies and Phonetic and Orthographic Computer Analysis (POCA) for your potential name candidates

   The EMA NRG notes that the main reason for name rejection is orthographic/phonetic similarity, with additional factors having an impact. In order to identify and remove any name candidates with the potential for rejection, it is recommended that full validation studies, with safety and promotional assessments, are conducted.

   To specifically address the orthographic/phonetic similarities, a full POCA analysis should be completed for name candidates. EMA NRG continues to see the benefit of using POCA as a complementary tool to support identification of potential objections and, as such, so should you.

2. Submit two names for review

   The NRG’s most recent research shows that in 2016, of those who submitted only one name for review, only 36% were granted approval, but those that submitted two names for review saw their approval rating jump to 67%.

   When gaining approval on first submission saves you valuable time and money, these increased odds are crucial.

3. Don’t submit names without properly developed submission documents

The NRG has a limited time for analysing new names, and well-developed submission documents help them make their review of names more efficient and effective. It is highly recommended to work with an outside organisation that specialises in and has extensive experience of creating these documents to achieve the quality and thoroughness the EMA looks for.

Well-crafted submission documents offer a valued source of information to the EMA NRG to support their decision, and need to provide easily reviewed proof that the names are not promotional and linguistics have been tested, along with allowing the NRG to review handwritten examples.

For those with current names in development, these changes present a need for immediate adjustment in order to keep the asset on track for submission. But the impact doesn’t stop there - these are important changes to be aware of for those with assets in all phases of development.

The final piece of advice is don’t try and go it alone. The regulatory landscape is complicated and always subject to change, so reach out to your branding partner today to get your asset on the right track for submission.

Barbara Gerber is VP managing director at Addison Whitney, part of INC Research/inVentiv Health, leading the industry in pharmaceutical brand name approvals