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Question 9 of 20 Fundamentals Concept

Which medicines must use the EU centralised procedure?

Short answer

The centralised procedure is compulsory for new active substances treating HIV or AIDS, cancer, diabetes, neurodegenerative diseases, autoimmune and other immune dysfunctions and viral diseases, and for biotechnology medicines, advanced therapy medicines and orphan medicines. One European Commission decision then covers every EU Member State plus Iceland, Liechtenstein and Norway.

Why

EMA's Committee for Medicinal Products for Human Use (CHMP) evaluates the application, and the European Commission issues a legally binding decision, normally within 67 days of the CHMP opinion. EMA describes up to 210 active days of assessment, interrupted by clock stops: a list of questions at day 120, usually answered within about three months, and a list of outstanding issues at day 180, usually answered within about a month. In practice, approval takes around a year.

Accelerated assessment can cut the active time to 150 days for medicines of major public health interest. The procedure is optional for other new active substances and for products that are a significant innovation. Most other medicines go through national, decentralised or mutual recognition routes.

For a biotech company, the practical point is that almost every novel biologic, gene therapy or oncology drug will be centralised, so there is one dossier and one decision, but also one chance. A negative opinion affects the whole EU at once. The EU reached political agreement on reforming its pharmaceutical law in December 2025, so check whether any change has started to apply.

A strong answer covers

  • Compulsory scope: therapeutic areas, biotech, ATMP, orphan
  • CHMP opinion then Commission decision
  • 210 active days plus clock stops, around a year in total
  • Accelerated assessment at 150 days
  • Pending EU pharmaceutical law reform

Common mistakes

  • Saying EMA itself grants the marketing authorisation.
  • Quoting 210 days as calendar time to approval.
  • Assuming all new medicines must go through the centralised route.