Accelerated Assessment
If the product is considered to be of major public health interest and is innovative, the accelerated assessment may be requested under Article 14(9). A request for accelerated assessment should be submitted as early as possible but this must be at least 10 days before the CHMP meeting which takes place prior to the start of the procedure. Accelerated assessment results in an opinion within 150 days.
Marketing Authorization under Exceptional Circumstances
Article 14(8) of Regulation 726/2004 allows for the granting of an MA under exceptional circumstances. This applies when the applicant can justify that full safety and efficacy data cannot be provided. The Regulation cross-refers to the grounds set out in Part II of Annex 1 of Directive 2001/83 as amended, which specifies the following reasons:
- It would be contrary to generally accepted principles of medical ethics to collect such information.
Even if additional data are provided subsequent to approval, the MA remains under exceptional circumstances.
The difference between conditional approval and approval under exceptional circumstances are summarized below:
|
Conditional MA |
Exceptional Circumstances MA |
|
Demonstrate positive benefit-risk balance, based on scientific data, pending confirmation. |
Comprehensive data cannot be provided (specific reasons foreseen in the legislation) |
|
MA valid for one year, on a renewable basis |
Reviewed annually to reassess the risk-benefit balance, in an annual re-assessment procedure. |
|
Once the pending studies are provided, it can become a “normal” MA |
It will normally not lead to the completion of a full dossier and become a “normal” MA |
