Accelerated assessment and the PRIME scheme

Accelerated assessment is the procedure by which the Committee for Medicinal Products for Human Use reduces from 210 to 150 days the time for examining a centralised authorisation application, for a medicinal product of major interest from the point of view of public health, in particular in terms of therapeutic innovation. It is provided for by Regulation (EC) No 726/2004. The PRIME scheme (PRIority MEdicines), launched by the European Medicines Agency in 2016, strengthens upstream support for the most promising medicinal products.

Conditions for accelerated assessment

The applicant requests accelerated assessment before filing its authorisation application, showing that the medicinal product addresses an unmet medical need and is of major public health interest. The Committee for Medicinal Products for Human Use rules on that request. Acceleration does not alter the substantive requirements regarding quality, safety and efficacy. The Committee may also revert to the standard timetable during the examination where major issues remain, which is not unusual in practice.

The PRIME scheme

The PRIME scheme is aimed at medicinal products that target an unmet medical need and for which preliminary clinical data suggest a major therapeutic benefit. It creates no legal status and does not guarantee authorisation. It offers early and enhanced dialogue with the Agency, the early appointment of a rapporteur, scientific advice at key development milestones and the prospect of accelerated assessment at the time of filing. Small and medium-sized enterprises and academic applicants may enter it at an earlier stage of development.

Impact on the protection timetable

An authorisation obtained more quickly benefits patients and brings marketing forward, but it also alters the balance of protection. The duration of the supplementary protection certificate depends on the interval between the filing of the patent application and the first authorisation in the Union, and a shorter development period reduces the certificate or even makes it pointless. Data protection, which runs from authorisation, then gains in relative importance. Accelerated assessment may also be combined with a conditional marketing authorisation.

Key points

Accelerated assessment reduces to 150 days the examination of a centralised application for medicinal products of major interest, without easing the substantive requirements. The PRIME scheme supports these medicinal products upstream but confers no rights. A faster authorisation shortens the duration of the supplementary protection certificate. The protection timetable (patent, certificate and data) should be modelled before requesting acceleration, and a sufficiently mature dossier should be filed to avoid reverting to the standard timetable.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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