The legal status of investigational pharmaceutical products for human use varies from country to country; in some of them, these products are manufactured and inspected like "normal" licensed pharmaceutical products. In most countries, however, they are not covered by legal and regulatory provisions in the areas of good manufacturing practice (GMP) inspection, etc.

However, the EC guide on GMP recommends that the principles of GMP should be applied, as appropriate, to the preparation of these products, and the WHO guide on GMP, according to the statement in the general considerations is applicable to "the preparation of clinical trials supplies". The present guidelines supplement both the WHO guide on GMP and the guidelines on good clinical practice (GCP) for trials on pharmaceutical products. The application of the principles of GMP to the preparation of investigational products is necessary...