What is the Centralized Procedure?

What is the Centralized procedure (CP)?

The European Medicines Agency’s (EMAs) Centralized Procedure (CP) is a regulatory pathway within the European Union (EU) for the approval of pharmaceutical products within the European Economic Area (EEA). It provides single marketing authorization to a product so that the same product can be marketed and distributed in all other EU Member States. This is important as it streamlines the approval processes involve in order to support timely access to medicines within the region. Many pharmaceutical companies that wish to market their products within all of the EEA tend to choose the CP route for product authorization.

Overview of the Centralized procedure

A pharmaceutical company must submit a marketing authorization application (MAA) to EMA where the dossier must include detailed information on the product’s quality, safety, and efficacy. The Committee for Medicinal Products for Human Use (CHMP) and EMA jointly evaluate the MAA. The CHMP usually constitutes representatives from EU Member States and collectively provide scientific feedback on the MA.

The CHMP evaluates the information that the applicant has provided related to the product’s manufacturing process, pre-clinical & clinical data, and risk-benefit profile. It can request from additional information from the applicant as required. It is important for the applicant and CHMP to closely collaborate to make sure the evaluation is comprehensive and supported by comprehensive information.

Timelines centralized procedure

The application assessment for a new product may take up to 210 “active” days which can be interrupted by at least one “clock-stop”. The applicant can provide answers to any questions raised by the CHMP during this period. This “clock-stop” period occurs after day 120, but can also happen after day 180 when the CHMP has adopted a list of questions that need to be addressed by the applicant.

The CHMP provides an opinion on the application by day 210 on whether the product should be granted MA. After this opinion, the European Commission (EC) issues the decision on granting a MA within 67 days. This decision is applicable for all EU Member States.

These timelines may be accelerated or expedited in particular situations. Indeed, the CP provides pharmaceutical companies with many advantages in providing timely market approval. Its streamlined process for multiple EU countries means that the efforts on time and resources are reduced in order to obtain market approval. It also ensures adherence to the stringent regulatory standards while bringing innovative therapies to the European market.

DReg’s Capabilities

DDReg has supported its customers for navigating the Centralized Procedure to ensure rapid market access in Europe:

Authoring, compilation, and review of MAAs for submission to EMA and other EU competent authorities

Preparing responses to agency queries

QPPV support for EEA region

Marketing Authorization Holder (MAH) services for EEA region

Developing robust regulatory strategy for products through centralized procedure

Post approval lifecycle management including variations, change controls, renewals for MAA