Regulatory Focus™ > News Articles > EMA Releases New Guideline Meant to Clarify Process for Naming Drug Products

EMA Releases New Guideline Meant to Clarify Process for Naming Drug Products

Posted 07 June 2013 | By Alexander Gaffney, RAC

Around the globe, healthcare product regulators have expressed an interest in-and occasionally concern with-naming conventions for brand-name pharmaceutical products. EU regulators are no exception to this rule, and announced this week that they have issued new revisions to a guideline regarding the acceptability of names for human medicines.


While many consumers might consider branded pharmaceutical names a marketing tool-which they undoubtedly are-regulators are far more concerned with how names might affect the safety of a product in practical terms.

Take, for example, the US Food and Drug Administration (FDA), which recently took to the pages of the New England Journal of Medicine to argue that its regulation of branded drug names was proper after being criticized by researchers who maintained that the pharmaceutical industry had an "insatiable proclivity to include the letters X and Z in their proprietary names," and that FDA had failed to police the practice.

Those researchers may be onto something. In the last few years, FDA has approved drugs with branded names like Xofigo, Xtandi, Xarelto, Xalkori, Xgeva, Zaltrap, Zytiga, Zelboraf, Zioptan, and Zometa. Those names can cause safety issues if pharmacists or other healthcare practitioners prescribe or dispense a drug incorrectly.

In recent months, however, FDA has moved to reduce medication errors by issuing a new guidance document meant to build safety into drug naming conventions by requiring sponsors to conduct proactive risk assessments.

Health Canada, too, has released a new process for branding drugs with proprietary names, insisting that companies go through a look-alike sound-alike (LASA) detection process meant to root out potential mix-ups before products reach the market. That process involves an algorithmic assessment called a Phonetic Orthographic Computer Analysis (POCA) score. Any drug registering a similarity score of 65% or above is flagged as being potentially problematic.

New EMA Guideline

Now the European Medicines Agency (EMA) is looking to refine its approach toward the same issue, clarifying details of a newly-revised guideline and releasing it for public consultation.

EU regulators said the update clarifies four aspects of the previous iteration of the guideline: the criteria applies to address safety and public health concerns, international non-proprietary naming issues, product-specific concerns and the procedure by which sponsors should submit proposed/invented name requests.

For example, EMA notes that drug names should take into account the potential for confusion in the drug's indication, patient population, pharmaceutical forms, routes of administration, strengths, dispensing settings, legal status of the drug or orphan drug status. In addition, companies should assess what harms would occur if a mix-up were to occur.

Further, the drug name itself should not be promotional in nature (e.g. OncoCure-All), and the sponsor should make all similar names available to EU regulators for assessment.

EMA also noted that several types of products had specific concerns associated with them. For example, radiopharmaceuticals used to target organs should avoid using the organ in the name of the drug to avoid "misleading connotations should an extension of the indication include new target organs."

EMA notes that its process is more subjective in nature, with each competent authority of each EU member state weighing in on the name opposed to Health Canada's more objective algorithmic-based naming adjudication process.

EMA's full guideline may be found here. Comments will be accepted until 30 August 2013.

EMA: Draft guideline on the acceptability of names for human medicinal products processed through the centralised procedure


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