The European Medicines Agency (EMA) has opened a second consultation period for its guideline on requirements for investigational advanced therapy medicinal products (ATMP) in clinical trials.

The first version of the guideline was open for consultation from February to August 2019. Comments received during this consultation period have been reviewed and applied, where possible, in the guideline, according to the agency. The new consultation period will be open until May 31.

The 60-page guideline provides guidance on the structure and data requirements for trial applications for exploratory and confirmatory ATMP trials and covers development, manufacturing and quality control, in addition to clinical and nonclinical development of investigational ATMPs.

Requirements for exploratory trials, including first-in-human studies and confirmatory trials, including a perspective toward application for marketing authorization, are addressed in the draft guidance.

Among the clinical topics covered are details of requirements for active substances and manufacturing requirements for investigational medicinal products and control of excipients. Nonclinical topics include pharmacology, pharmacokinetic and toxicology studies, in addition to minimum nonclinical data requirements before first-in-human studies.

After the consultation ends, the final version will be adopted by the Committee for Advanced Therapies and the Committee for Medicinal Products for Human Use and put into effect at unspecified dates.

Read the draft guidance here.