EMA offers simultaneous review of products for EU and non-EU markets

The Committee for Medicinal Products on Human Use (CHMP) has announced in the minutes of its Organizational Matters (ORGAM) meeting of 17 February 2020, which were published on 7 May 2020, that it has adopted the EMA proposal for the simultaneous submission and assessment of EU centralized marketing authorization applications (MMAs) and applications for a scientific opinion under Article 58 of Regulation (EC) 726/2004 on the authorization and supervision of medicinal products for human and veterinary use.

Under the Article 58 procedure, also known as EU Medicines4All, the CHMP provides scientific opinions on medicinal products intended exclusively for markets outside the European Union. Medicinal products eligible for this procedure are products used to prevent or treat diseases of major public interest, such as vaccines. The aim of this procedure is to facilitate patient access to essential medicinal products in non-EU countries since the scientific opinion by the CHMP may be used to support local registration procedures.

As explained in the minutes of the ORGAM meeting, the simultaneous evaluation of medicinal products can be helpful when these products are needed for both EU and non-EU populations. Applicants will have to submit two separate applications, one for each procedure, which will be evaluated in parallel.

The submissions will be handled by the same rapporteurs and co-rapporteurs and will result in two assessment reports and two separate opinions. The two assessment reports are expected to be identical, except where there may be different conditions of use of a medicinal product.

The CHMP explains that this parallel evaluation is expected to optimize the use of national competent authorities’ resources, prevent assessment discrepancies and reduce the time necessary to complete an Article 58 opinion in cases where the medicinal product is also intended to be used in the EU.

The parallel evaluation of the submissions is not expected to have any impact on the fees paid by the applicants.

The process of simultaneous evaluation of EU centralized marketing authorization applications and Article 58 submissions has been available as of March 2020.