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Draft guideline on the requirements for ATIMPs in clinical trials, EMA, 31th of January 2019.

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

 

Further information


 
Dr Claudia Papewalis is giving a GMP for ATMP training

GMP for ATMPs

If you want to know more about the regulatory requirements requested for manufacturing ATMPs, contact our experts or take part at one of our internal GMP training courses.

A scientist is looking at t-cells visible at a computer screen

GMP-compliant manufacturing process

Valicare supports start-ups like polybiocept in transferring cell-culturing methods developed at the laboratory into a GMP-compliant manufacturing process. Check the press release and get an overview about our GMP for ATMP services.

cell culture, ATMPs

„Guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products”

On 22th of November 2017 the European Commission adopted the "Guidelines on Good Manufacturing Practices (GMP) specific to Advanced Therapy Medicinal Products".