EMEA Accelerated Review

In Europe, a sponsor may request an accelerated review of a marketing authorisation by the EMEA on grounds that the product is of major interest to public health, particularly from the viewpoint of therapeutic innovation. If granted, an accelerated review must be conducted within 150 days as opposed to the 210 days allowed for a standard technical assessment. 

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At least 4—6 months before submission, the applicant should notify the EMEA of their intention to submit an application. The applicants intent to submit notification lettei should include the draft SPC of the new product as a kind of product profile, the proposed trade name and - if not a product for which the CP is mandatory - also a justification as to why the product falls under the procedure. If the appHcant can claim exceptional circumstances (e.g., unmet medical need, acceler-ated/limited development programme, orphan drug), which may lead to an accelerated review, this should also be claimed in this letter. 

The CTDs were implemented in July 2003. They are format-based documents for submission to the regulatory authorities the country-specific process of review, for example, via the IND and NDA of the United States or the Centralized Procedure of the EMEA, is not affected. The harmonized CTDs help to reduce cost and accelerate approval time. Figure 7.1 shows the CTD structure five modules with Module 1 for regional administrative information specihc to each country. Module 2 on summary of quality, nonclinical and clinical. Module 3 on quality. Module 4 on nonclinical study reports, and Module 5 on clinical study reports. 

Accelerated Assessment The EU introduced the accelerated assessment in November 2005. The aim is to speed up the regulatory procedure to enable patients access to new medicines. The EMEA review time for accelerated assessment is 150 days. See Exhibit 8.9 for the approval of Soliris (eculizumab),... 

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