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Licensing new antibacterial agents - a European perspective
1Medicines Control Agency, 1 Nine Elms Lane, Market Towers, SW8 5NQ, London, UK. mair.powell@mca.gov.uk
International Journal of Antimicrobial Agents
|November 25, 2000
Summary
Two EU marketing authorization procedures exist for new antibacterial agents: Centralised and Mutual Recognition. These processes facilitate standardized drug development guidance and data presentation across all EU Member States.
Area of Science:
- Pharmacology
- Regulatory Affairs
Background:
- Marketing authorization for new antibacterial agents in the EU follows specific regulatory pathways.
- The European Agency for the Evaluation of Medicinal Products (EMEA) and its Committee on Proprietary Medicinal Products (CPMP) play key roles.
Purpose of the Study:
- To outline the two primary procedures for granting marketing authorization for antibacterial agents in the European Union.
- To highlight the impact of these EU-wide procedures on drug development and regulatory guidance.
Main Methods:
- Description of the Centralised Procedure involving a single application to the EMEA.
- Explanation of the Mutual Recognition Procedure where one Member State's authorization is recognized by others.
Main Results:
- Both procedures lead to a harmonized Summary of Product Characteristics (SPC) across all EU Member States.
- EU-wide procedures have enabled the development of specific guidance for antibacterial agents by the CPMP.
Conclusions:
- The Centralised and Mutual Recognition Procedures streamline the approval of antibacterial agents in the EU.
- These regulatory frameworks support the development of clinical guidelines and the presentation of in-vitro data, including pharmacokinetic-pharmacodynamic relationships.