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Abstract

Efficient and frequent communication between both the pharmaceutical industry and the European Medicines Agency (EMEA) is vital for the development, registration, and maintenance of medicinal products. Examples for such dialogue in the European Union are the Scientific Advice Procedure, clarification meetings, and oral explanations as well as the Product Information Linguistic Review Procedure during the Centralized Procedure. The Scientific Advice Working Party provides advice on scientific questions regarding a medicinal product according to defined timetables depending on the number and complexity of the questions. Meetings in relation to a Centralized Procedure are held with the EMEA project manager, Rapporteur, and Co-Rapporteur to discuss administrative questions, the objections to the registration dossier, and the response strategy and to build a good relationship between the involved stakeholders. In the Product Information Linguistic Review Procedure, the English version of the product information of a medicinal product is reviewed first. After the adoption of the positive opinion in the Centralized Procedure, the high quality of the translations into the remaining 18 official languages of the European Union has to be ensured. Based on the experience gained with the dialogue between the pharmaceutical industry and the EMEA in the past years, these procedures have been modified, which already has had a positive impact on the outcome of registration procedures. This good result should encourage all involved stakeholders to further improve communication to achieve the common goal for fast access to innovative, safe, and efficacious medicinal products of high quality to patients.

Keywords

Scientific Advice Procedure Oral Explanation Meeting Product Information Linguistic Review Process Centralized Procedure

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References

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Dialogue between Companies and the EMEA regarding the Centralized Procedure from an Industry's Point of View

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