In an effort to help assessors evaluate initial marketing authorization applications, the European Medicines Agency (EMA) has taken the initiative to extend the use of “early background summaries”.

Background

The “early background summary” is the EMA’s product team summary of the critical background information concerning a product, including its regulatory and procedural aspects, as well as the product team’s comments on the product information.

The concept of EMA’s “early background summary” pilot was launched in 2014. Under the pilot, the EMA’s product team provided the rapporteurs in different agency committees – the Human Medicines Evaluation Committee (CHMP), the Pharmacovigilance Risk Assessment Committee (PRAC), and, where appropriate, the Committee of Advanced Therapies (CAT) – with “early background summaries” of 21 marketing authorization applications, at the Day 10 of the assessment of initial marketing authorization applications. To achieve these goals, EMA works closely with representatives of the CHMP, PRAC, and CAT.

The criteria under which the 21 marketing authorizations applications were selected involved among other things:

  • the relevant legal complexities; the type of the marketing authorization;
  • the type of product under assessment;
  • the disease concerned with regard to current regulatory and scientific advancements;
  • scientific advice for other relevant drugs or indications; and
  • novel consensus in the field of disease.

The “early background summaries” are intended to provide assessors with “regulatory intelligence analysis” on specific drugs that are currently assessed or evaluated by the EMA’s scientific committees. In that way, assessors are provided with advice on a potential requirement of additional regulatory/ legal advices, or, the need to collect additional information.

The way forward

EMA has stated that “early background summaries” provide assessors with considerable help as both, the critical background of the evaluated product and the provided information, might be similar to the new application under evaluation.

Considering the positive feedback received with regard to the pilot, the EMA plans to enhance and increase the use of “early background summaries” to a Day 10 step during the assessment of the initial marketing authorization applications. The criteria under which the selection of the product for which “early background summaries” will be developed will also be enhanced.