FIGURE 1 | The European centralized procedure.

From the following article:

Typical pitfalls in applications for marketing authorization of biotechnological products in Europe

Christian K. Schneider & Gabriele Schäffner-Dallmann

Nature Reviews Drug Discovery 7, 893-899 (November 2008)


Typical pitfalls in applications for marketing authorization of biotechnological products in Europe

The centralized review process is initiated with the submission of a letter of intent by the applicant to the European Medicines Agency (EMEA) up to 7 months ahead of the marketing authorization application (MAA) in order to allow the EMEA's Committee for Medicinal Products for Human Use (CHMP) to plan and designate the Rapporteur and Co-Rapporteur. These are members of the CHMP that will prepare two independent assessment reports during the initial review period of 80 days. The EMEA is the project leader and contact for any pre-submission meetings to prepare the MAA. Following validation of the application and confirmation by the CHMP Rapporteur and Co-Rapporteur that they have received the MAA dossier, the EMEA starts the procedure at the monthly starting date published on the EMEA web site. A timetable is prepared by the EMEA Product Team Leader in consultation with the Rapporteur and the Co-Rapporteur. All member states are involved by commenting on the initial assessment reports provided by the two Rapporteurs. The applicant will then receive a List of Questions at day 120 of the procedure, to which the company normally needs to respond within 3 months clock-stop. This will trigger a second review round. In case the response is still not satisfactory, another written answer and/or oral presentation might be requested to clarify issues still outstanding. Based on this review process, the CHMP concludes on the approvability of the product and the European Commission issues the legally binding approval decision. It should be emphasized that the active time of the scientific review process by CHMP is 210 days, but effectively the overall review period until the CHMP issues an opinion can be considerably longer owing to prolonged clock-stop periods when major problems have been encountered. Following a positive CHMP opinion at day 210, the applicant is obliged to provide translations of the product information in all European languages, which is followed by a linguistic check by the EU member state authorities. CHMP Opinion and the product information in all EU languages are then transmitted to the European Commission. The European Commission as the executive body finally issues the marketing authorization that is automatically valid in all EU member states. BWP, biologicals working party; GCP, good clinical practice; GLP, good laboratory practice; GMP, good manufacturing practice; QRD, quality review of documents.

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