EU Procedures & Committees

EMA committee that assesses quality, safety, and efficacy of advanced therapy medicinal products (ATMPs) and provides recommendations within the centralised procedure.

An EU marketing authorisation route where a single application to EMA leads to one marketing authorisation valid across EU/EEA (for eligible products).

EMA committee responsible for preparing opinions on questions concerning medicines for human use, including assessment of marketing authorisation applications under the centralised procedure.

A coordination group facilitating harmonised decisions for human medicines assessed via mutual recognition and decentralised procedures in the EU.

In EU DCP/MRP, a Member State where the applicant seeks marketing authorisation and that relies on the RMS assessment while performing national steps.

A second appointed assessor who supports and independently reviews an application alongside the rapporteur to strengthen the assessment.

EMA committee that reviews applications for orphan designation and provides opinions on whether criteria for orphan status are met.

An EU procedure for obtaining marketing authorisations in multiple Member States simultaneously when the product is not yet authorised in any EU Member State.

The legally binding EU decision that grants a marketing authorisation following a positive CHMP opinion under the centralised procedure.

A public document describing EMA’s assessment of a medicine authorized via the centralised procedure, including key benefits/risks and scientific considerations.

The entity legally responsible for placing a medicinal product on the market in a given region and for meeting post-authorisation obligations.

An EU procedure where one Member State’s existing marketing authorisation is recognized by other Member States to extend authorisation to additional countries.

A country’s medicines regulator responsible for national authorisations, clinical trial oversight, inspections, and implementation of EU procedures where applicable.

EMA committee responsible for assessing Paediatric Investigation Plans (PIPs) and related waivers/deferrals to support development of medicines for children.

An EU development plan describing studies in children and related measures (waivers/deferrals) required for many applications.

EMA committee responsible for assessing and monitoring safety of human medicines, including risk management and pharmacovigilance activities.

A member of an EMA committee appointed to lead the assessment of an application and coordinate the assessment report.

An EU regulatory procedure used to resolve concerns or disagreements about a medicine (e.g., safety, efficacy, quality) across Member States, leading to harmonised outcomes.

In EU DCP/MRP, the Member State that leads the scientific assessment and prepares key assessment reports for other Member States to consider.