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Table 1 Definition of clinical trials on typical investigational medicinal products as well as less typical investigational medicinal products.

From: Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries

Category

Includes

Clinical trials on typical investigational medicinal products

Phase I to IV clinical trials on medicinal products, that is any substance or combination of substances presented for treating or preventing disease in human beings. Any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings is likewise considered a medicinal product.

Clinical trials on biopharmaceutical investigational medicinal products or other less typical investigational medicinal products

Phase I to IV clinical trials on

 

- Biological medicinal products, i.e., proteins preceded either from biological material by standardised purification techniques or by recombinant DNA technologies or hybridoma or monoclonal antibody methods.

 

- Vaccines.

 

- Advanced therapy medicinal products, consisting of

 

   - gene therapy medicinal products (human or xenogeneic);

 

   - somatic cell therapy medicinal products (human or xenogeneic);

 

   - tissue engineered product, i.e., a product that contains or consists of engineered cells or tissues (human or xenogeneic).

 

- Plasma-derived medicinal products.

 

- Blood products.

 

- Radio-pharmaceuticals and precursors.

 

- Homeopathic medicinal products.

 

- Herbal medicinal products.