ATMP Draft guideline on the requirements

Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products (ATMPs) in clinical trials.

To take into account the characteristics of advanced therapy medicinal product (ATMP) development and the implementation of clinical trials with ATMPs, the Committee of Advanced Therapies (CAT) of the European Medicines Agency (EMA) published on 21 February 2019 the draft of the new guideline on quality, non-clinical and clinical requirements for investigational ATMPs in clinical trials. Comments on this draft could be submitted until 01 August 2019.

With this new guideline ATMP manufacturers are now provided with guidance on the structure and data requirements for a clinical trial application for exploratory (primary objectives are safety and tolerability) and confirmatory (for obtaining pivotal data for marketing authorization application) trials with ATIMPs with focus on exploratory trials. Thereby the guideline addresses various disciplines including development, manufacturing and quality control as well as non-clinical and clinical development of ATIMPs.

The complete draft of the EMA guideline is available here.