Module 1 2021

30/06/2021

 Principle: ● CHMP and PRAC, with the support of the COVID-ETF, review data as they become available on a rolling basis, while development is still ongoing ● Assessment performed by Rapporteur and Co-Rapporteur; outcome adopted by CHMP  Eligibility: ● Applicants should email 2019-ncov@ema.europa.eu with: – a justification for assessing the product via a rapid procedure; – data supporting the proposed role of the product in the COVID 19 setting; – data supporting proof of concept. – Applicants can submit it together or after the request for eligibility to the centralized procedure  Several rolling review cycles possible ● Each cycle a minimum of 2 weeks depending on amount of data  Submission formal MAA ● Once CHMP considers data package sufficient complete ● Shortened timetable depending on remaining data to be assessed Rolling Review

The Organisation for Professionals in Regulatory Affairs

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Strategic choices Type of Application

• Mandatory scope of Centralised Procedure • Legal Basis • Complete • Bibliographic • Generic • Biosimilar • ……..

The Organisation for Professionals in Regulatory Affairs

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