Centralised Procedure

Definitions #

A single EU marketing authorisation process for medicines that, when approved, allows one drug to be sold in all EU member states.

Technical The EMA's regulatory pathway whereby a single application is evaluated to grant a centralized marketing authorisation valid across all EEA countries, mandatory for certain biotech and orphan medicines.

Example The new oncology drug received a marketing authorisation via the Centralised Procedure in the EU.

Etymology #

From 'centralise' (to concentrate) + 'procedure' (a process), referring to the single EU-level pathway established in 1995.

Collocations #

marketing authorisation 上市许可（通过集中程序获得的药品许可）
centralised procedure application 集中程序申请（向EMA提交的申请）
EMA evaluation EMA评估（集中程序中的科学审查）
one-stop-shop 一站式（集中程序的非正式说法，指单一申请覆盖多国）

Real Business Examples #

The new oncology drug received a marketing authorisation via the Centralised Procedure in the EU.
Pharmaceutical companies must prepare a dossier meeting EMA requirements for centralised procedure applications.

Register & Variants #

Register: formal
BrE/AmE: 英式拼写 centralised，美式省略为 centralized，但在欧盟语境中多用英式

Synonyms & Antonyms #

Synonyms: EMA Centralised Procedure, Centralized Procedure (US spelling)
Antonyms: National Procedure, Decentralised Procedure

Common Errors #

把中央程序与互认程序（MRP）混淆中央程序是单次申请所有欧盟国家；互认程序是先在成员国批准，再互相承认，流程不同
误以为中央程序适用于所有药物中央程序是强制性的仅针对特定药物（如生物药、孤儿药和特定疫苗），其他药物可选择国家程序或互认程序

Confusable Terms #

Decentralised Procedure vs Centralised Procedure: 分散程序由多个国家同时审查但独立批准，不同于中央程序的单一授权

Frequently Asked Questions

Is Centralised Procedure required for all drugs??

不是，仅对某些类别（如生物技术药物和孤儿药）强制，其他可自愿选择

What is the benefit of the Centralised Procedure??

一次申请即可获得全 EU/EEA 范围内的上市许可，节省时间和成本

Published: 2026-09-24 Category: Regulatory