Licensing new antibacterial agents - a European perspective.

There are two procedures by which new antibacterial agents may be granted marketing authorisation in the EU. The Centralised Procedure involves a single application through the European Agency for the Evaluation of Medicinal Products (EMEA). If a positive opinion is advised by the Committee on Proprietary Medicinal Products (CPMP), the European Commission grants a marketing authorisation in all EU Member States (MS). In the Mutual Recognition Procedure, the first EU country to license the drug becomes the Reference MS (RMS) and the company then requests some or all of the other MS to recognise this first authorisation. Both Centralised and Decentralised Procedures result in a Summary of Product Characteristics (SPC) which is identical in all EU MS. These EU-wide procedures have made possible the development of CPMP guidance regarding the clinical development of antibacterial agents, the presentation of data on in-vitro activity in SPCs, and the exploration of the pharmacokinetic-pharmacodynamic relationship. In addition, many CPMP guidelines that are applicable to a wide range of drugs, such as that regarding drug development in children, are pertinent to antibacterial agents.