Procedural and regulatory know-how for China biotech in the EU

Drug development requirements in China differ substantially from the EU legislation. Despite this, increasingly Chinese biotech firms are seeking to obtain a marketing authorisation in Europe following recent precedents. Before applying for a marketing authorisation, applicants must assess the correct pathway to market in Europe, analyse the clinical, non-clinical and quality data package for potential gaps and ensure content addresses European requirements and expectations.

Applicants must begin communicating with the EMA during the early development stages of medicinal products to identify the optimal EMA procedure. They must understand the EMA Centralised Procedure Timeline; from Early Preparation Phase to EC Decision, in order to ensure compliance or significant delays can result.

In this white paper, ICON’s experts outline potential regulatory strategies and interaction plans for sponsors in China as a guide for marketing authorisation applications in the centralised procedure to the EMA. These allow the marketing authorisation holder to market a drug product in all European Union (EU) Member States, in addition, specific countries in European Economic Area (EEA), with a potential patient pool of over 450 million people. The paper also includes a focus on EMA's Policy 0070, covering transparency requirements for clinical data.