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 authorised by a centralised authorisation procedure, like through the American FDA (Food and Drug Administration) or the EMA (European Medicines Agency), or can be subjected to national or decentralised authorisation procedures in every separate country.
A marketed drug has three names
- chemical name: 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.
- generic name: commonly used to identify a drug during its useful clinical lifetime, while the pharmaceutical company that patents the drug creates the brand name (trademark).
- 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 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 harmonise 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.
Centralised procedure (EMA)
Article 6 of the EC Regulation says “each application for the authorisation of a medicinal product for human use shall include the use of a single name for the medicinal product.” The Centralised Procedure, therefore, requires one single name for the medicinal product to be authorised.
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 Authorisation Holder”.
In practice, many companies develop their own names for their medicinal products. Applications through the centralised 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 authorisations in the EU.
Once a marketing authorisation has been granted, the marketing-authorisation holder can legally begin to market the medicine in all EU countries.
National or decentralised procedure
Each EU Member State has its own national authorisation procedures for the authorisation, within their own territory, of medicines that fall outside the scope of the centralised 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 authorisation of a medicine in more than one EU country if it has not yet been authorised in any EU country and it does not fall within the mandatory scope of the centralised procedure. If a company has a medicine authorised in one EU Member State it can apply for this authorisation to be recognised 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 Authorisation Holder”.
Although not mandatory it is common use that all companies submitting marketing authorisation 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.
For more information, have a look on the website Pharmanaming by Globrands!