Investigational medicinal products

Like authorised medicinal products, investigational medicinal products must be manufactured in accordance with GMP. Regulation (EU) 2017/1569 describes additional rules for investigational medicinal products.

Investigational medicinal products for early phase clinical trials do not need to meet the same requirements as authorised medicinal products, regarding for example validation of the manufacturing process and analytical methods.

Manufacturing of products for blinded clinical trials, where the physician and/or the patient do not know whether the investigational product is a placebo or active, requires the manufacturer’s systems to ensure that products appear identical and that the blinding information does not go astray.

Regulatory framework

There are different rules governing the manufacture of investigational medicinal products for humans and for animals. The rules are similar, and it is possible for a manufacturer to have authorisation to manufacture investigational medicinal products for both humans and animals at the same site.

Specific rules for human investigational medicinal products

Specific rules for veterinary medicinal products, including investigational products