for the healthcare and pharmaceutical industry
Pharmaceutical drug naming and approval
Pharmaceuticals are considered as the most highly regulated industries worldwide. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing, marketing and labeling of pharmaceutical products. Medicines can be authorized by a centralized authorization procedure, like through the American FDA (Food and Drug Administration) or the EMA (European Medicines Agency), or can be subjected to national or decentralized authorization procedures in every separate country.
The FDA began reviewing drug names beginning in the early 1990’s. However, it was a landmark report published in 1999 by the Institute of Medicine, linking drug name similarity to medication error, that led the FDA to increase its attention to and oversight of this part of the overall drug approval process. EMEA began examining “invented” names in 1995 and set up a specific working group to oversee the process in 1999. Both agencies initiated proprietary nomenclature assessment in the interest of public health and safety. This was based on the belief that names that sound alike or look alike can cause confusion, and in the worst cases, lead to medication errors.
A marketed drug has three names: chemical name, generic name and brand name
The chemical name is a scientific name based on the compound's chemical structure and is almost never used to identify the drug in a clinical or marketing situation.
The generic name is commonly used to identify a drug during its useful clinical lifetime, while the pharmaceutical company that patents the drug creates the brand name (trademark).
The brand name identifies the drug during the years that the company has exclusive rights to make, sell, and use it under patent law. Companies usually begin developing a brand name during Phase I of the Investigational New Drug Application (IND) process as a good brand name is essential to marketing success in the highly competitive pharmaceutical business.
European Medicines Agency
The EMA's role as a regulator is to protect and promote public and animal health by evaluating and supervising medication for both human and veterinary use. The EMA was created to harmonize the working practices of the various EU member state territories, reducing the costs for those requiring approval throughout the EU.
It is only after authorisation has been granted that a company can market a product. However, while regulatory approval might be granted by the EMA, there is still the legal side to consider, both in terms of registering the brand name as a trademark and checking that you are free to use that brand name.
Centralized procedure (EMA)
Article 6 of the EC Regulation says “each application for the authorization of a medicinal product for human use shall include the use of a single name for the medicinal product.” The Centralized Procedure, therefore, requires one single name for the medicinal product to be authorized.
The name of the medicinal product “may be either an invented name not liable to confusion with the common name, a common name or scientific name accompanied by a trademark or the name of the Marketing Authorization Holder”.
In practice, many companies develop their own names for their medicinal products. Applications through the centralized procedure are submitted directly to the Agency. Evaluation by the Agency's Scientific committees can take up to 210 active days plus 'clock stops', at the end of which the committee adopts an opinion on whether the medicine should be marketed or not. This opinion is then transmitted to the European Commission, which has the ultimate authority for granting marketing authorizations in the EU.
Once a marketing authorization has been granted, the marketing-authorization holder can legally begin to market the medicine in all EU countries.
National or decentralised procedure
Each EU Member State has its own national authorization procedures for the authorization, within their own territory, of medicines that fall outside the scope of the centralized procedure. In the Netherlands the CBG-MEB assesses and monitors the efficacy, risks and quality of medicines for humans and animals.
Companies can apply for simultaneous authorization of a medicine in more than one EU country if it has not yet been authorized in any EU country
and it does not fall within the mandatory scope of the centralized procedure. If a company has a medicine authorized in one EU Member State it can apply for this authorization to be recognized in other EU countries.
The name evaluation procedure
According to Article 1(20) of Directive 2001/83/EC, the name of the medicinal product “may be either an invented name not liable to confusion with the common name or a common name or scientific name accompanied by a trademark or the name of the Marketing Authorization Holder”.
Although not mandatory it is common use that all companies submitting marketing authorization wish to use invented names for their medicinal products.
In particular, the name of a medicinal product:
should not be liable to cause confusion in print, handwriting or speech with the (invented) name of an existing medicinal product.
should not convey misleading therapeutic or pharmaceutical connotations;
should not be misleading with respect to the composition of the product;
In order to identify potential name difficulties in an early stage, the EMA/ CHMP set up the Name Review Group (NRG), to perform the review of names.