The European Medicines Agency's (EMA) has released a revised version of its procedural advice for sponsors of medicinal products using the centralised procedure, part of an ongoing series of revisions to one of its key regulatory documents.
The centralised procedure, established in EC No. 726/2004, is intended to allow application sponsors to obtain a single marketing authorization from EMA that is accepted throughout the EU.
With the passage of additional legislation, the procedure continues to grow in complexity and requirements, and EMA regulatory updates one document, pre-authorisation procedural advice for users of the centralised procedure, to assist sponsors on how best to navigate its considerable complexities.
Among the 54 questions it answers-ranging from the conduct of pre-submission meetings to eligibility standards-are two newly revised sections.
Section Four: Naming Your Drug
Section four explains how products are to be named, and whether the branded ('invented') name of the product is acceptable from a public health standpoint. The naming of drugs is important to regulators because ones that are too similar or are easily confused may cause public health problems. Thus, a pain pill by the name of "Paintera" (painpillus genericum) might not be approved based on its similarity to similarly named hypothetical drugs, "Paintella" or "Paintena" based on, respectively, how similar the names sound and look.
EMA added that companies must also be sure that the names of their products are not liable to be confused with the scientific name of a product or with an already trademarked name.
Such products are reviewed by the Name Review Group (NRG), which determines if a product's proposed name is acceptable for public use. Approved names are able to be changed after marketing authorization is granted, but must undergo a new name review after the submission of a Type IAIN variation notification to EMA.
Section 53: Northern Europe
Section 53, meanwhile, is concerned with marketing authorization of centrally authorized products in Norway, Iceland and Liechtenstein-none of which are formal members of the EU. While they are signatories to the European Economic Area agreement, meaning that they are parties to the centralised procedure, decisions by the European Commission (EC) are not legally binding in Norway or Iceland. In those states, decisions on national authorization must be done on a case-by-case basis, though the countries will render a decision within 30 days of the EC's decision.