Distinctive brand names are essential in the pharmaceutical industry, as they play a crucial role in mitigating name-related medication errors. A brand name that is too similar to an existing medicinal product’s name, or is considered difficult to pronounce, spell, or remember can lead to confusion among healthcare professionals, patients, and caregivers, which may result in medication errors. Medication errors are a significant concern in the healthcare sector, and they can have severe consequences, including adverse reactions, hospitalization, or even death.
To ensure that brand names for medicinal products are safe and effective, the European Medicines Agency (EMA) has established the Name Review Group (NRG). The NRG is responsible for evaluating the suitability of proposed brand names for medicinal products in the European Union (EU). The NRG review process is rigorous, and it involves a comprehensive analysis of each proposed name ensuring the safe use of the product in all phases of the clinical setting, while evaluating its linguistic, cultural, and semantic aspects.
However, the high rejection rate of names submitted to the NRG is a cause of concern for pharmaceutical companies. Many companies struggle to get their brand names approved by the EMA, as the rejection rate is as high as 55%. The NRG review process can be perceived as unreasonable by some companies, and some rejections may seem unjustified. However, it is important to note that the NRG aims to ensure that brand names for medicinal products are safe, effective, and appropriate for the intended use. The NRG review process is essential in mitigating the risks of medication errors and ensuring patient safety.
To address the challenges of getting brand names approved by the EMA, pharmaceutical companies can seek the services of expert drug naming companies like Brand Institute and its regulatory affiliate, Drug Safety Institute. Drug Safety Institute, comprised of ex-naming regulators globally (including EMA, FDA, and Health Canada), has developed a methodology that is the best in the market in securing a name through the EMA and any other Regulatory Authority globally. Their expertise and experience in drug name development can help companies navigate the complex regulatory landscape and ensure that their brand names are safe and effective.
In conclusion, brand name approvals for medicinal products in the EU are a crucial part of drug safety. The NRG review process is rigorous, and while you are free to disagree with the reason for a rejection, it is important to remember that the EMA is tasked with ensuring that brand names for medicinal products are safe, effective, and appropriate for the intended use. Pharmaceutical companies can benefit from the services of expert drug naming companies like Brand Institute/Drug Safety Institute to ensure that their brand names are approved by regulatory authorities globally.
By: Nakos Balamotis