Regulatory Snapshot for Pharmaceutical Trade Naming Around the World

Proprietary naming regulations can differ between regulatory bodies around the world. Here we've highlighted a few important regulatory considerations for each government agency. Since regulatory guidance is constantly evolving, please verify that the information is current before proceeding with any regulatory pathway.

United States (Division of Medication Error Prevention and Analysis of FDA, DMEPA)

• A primary and secondary name can be submitted but the FDA will only review one at a time.

• Names may be reviewed during the IND phase for conditional approval or submitted with the NDA or BLA.

• FDA originated computer analysis for name similarity with defined thresholds of differentiation (Phonetic and Orthographic Computer Analysis - POCA).

European Union ((Invented) Name Review Group of EMA, NRG)

• The NRG meets 4-6 times a year to review names; only reviewing 75 names per meeting in order of submission. Names beyond the 75 submitted must wait until the next session for decision.

• Two names can be submitted for review at once to the EMA. Both names will be reviewed and evaluated.

United Kingdom (Medicines and Healthcare products Regulatory Agency, MHRA)

• There is no early name review or conditional approval.

• Applicants can submit up to three names in order of preference.

Australia (Therapeutic Goods Administration, TGA)

• There is no early name review or conditional approval.

• Australia requires each asset has an Australian Approved Name or an Australian Biologic Name, similar to USAN for the United States or INN in Europe.

Canada (Health Canada, HC)

• As part of the name evaluation, Health Canada utilizes the “search, simulate, synthesize” method which requires at least 5 prescription simulation scenarios with 100 practitioners.

• Health Canada requires data on name testing be timely, executed within the past 6 months.

• Health Canada also stipulates that at least 20-25% of respondents be French speakers.

Japan (Pharmaceuticals and Medical Devices Agency, PMDA)

• Sponsors must conduct name safety searches via Japan Pharmaceutical Information Center (JAPIC) to validate name candidates prior to submission. Sponsors submit only one name at a time as part of the NDA submission.

Mexico (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS)

• A pre-submission meeting is mandatory prior to submitting a marketing application.

Brazil (Agência Nacional de Vigilância Sanitária - Anvisa, GMMBP)

• Multiple name candidates can be submitted but sponsors must highlight a clear primary candidate.

• Brazil, like the US, uses POCA as a metric for name similarity. Names that have a high similarity score (greater than or equal to 70) in POCA, must have a risk matrix performed.

• Foreign companies cannot get marketing authorization directly with ANVISA; they must have a partner company in Brazil for importation and distribution of their drug in Brazil.

Saudi Arabia (Saudi Food & Drug Authority, SFDA)

• There is no early name review or conditional approval.

• During the Saudi FDA (SFDA) review, a sponsor can change its proposed drug name if a full review is not yet completed.
  

Each agency may differ slightly, but the goal of patient safety is universal. Navigating global regulatory requirements and best practices can be challenging. Leaderboard focuses on matching a submission strategy with your asset's commercial strategy to help our partners achieve approval around the world.

To learn more about our drug safety and regulatory services, visit our drug safety page. To speak with one of our experts for more drug safety insights, contact us.