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

Drug development requirements in China differ substantially from the EU legislation, and, to avoid regulatory setbacks, China-based companies must consider that drug development requirements in China differ substantially from the EU legislation as they prepare to perform regulatory submissions in the centralised procedure to the EMA.

Applicants must begin communicating with the EMA during the early development stages of medicinal products to identify the optimal EMA procedure and align with EMA product leads, rapporteur, and co-rapporteur. These interactions are critical to identifying the regulatory strategy for the optimal route to the approval of medicinal products. It subsequently aids the generation of the correct clinical, non-clinical and quality data during their development and in the marketing authorisation submission planning stage to ensure the best possible chance of a successful validation and subsequent likelihood of a positive opinion by the Committee for Medicinal Products for Human Use (CHMP).

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, which allows 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) (Iceland, Norway and Liechtenstein), with a potential patient pool of approximately 500 million people. The paper also includes a real-world case study outlining ICON’s success in guiding a specific China-based biotech to market through the EMA.