1、ICON and regulatory know-how for China biotech in the EU How to navigate European Medicines Agency registration and regulationProcedural and regulatory know-how for China biotech in the EU2ContentsExecutive summaryDefinitionsIntroductionHurdles for China-based biotech companies submitting MAAs to EM

2、AClinical trial and clinical dataAdministrative challenges to China-based biotech companies when entering the EUUnderstanding EMA regulatory processes and the EU centralised procedure for marketing authorisation Early engagement of China-based companies with EU EMA and national regulatory authoritie

3、sEarly and late interactions between the applicant and European Medicines Agency at scientific advice meetingsCase study:China-based biotech applications post-COVID-19ConclusionFurther reading3457 991011121314153Procedural and regulatory know-how for China biotech in the EUExecutive summaryApplicant

4、s must also 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 t

5、he 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

6、 a positive opinion by the Committee for Medicinal Products for Human Use(CHMP).ICON has experience providing regulatory direction and strategy to China-based clients during and after preparation for regulatory submissions in the centralised procedure to the European Medicinal Agency.In this white p