[From the chemical product to the authorization of drug marketing].

A great number of highly qualified specialists are involved in the drug development process, mainly chemists, galenic and pharmacokinetic experts, pharmacologists and toxicologists. The 7 to 15 years development process implies preclinical studies in thousands of animals as well as clinical studies in about 3,000 patients. Various mandatory studies, regulatory requirements as well as a drug assessment process lead to the possible marketing authorization approval. The drug assessment process usually leads to a sound assessment of pharmaceutical quality of clinical benefit in each indication proposed; yet, occasionally, the assessment of safety is incomplete. Performing phase IV studies, collecting pharmacovigilance data is a requirement in the future. The prescriber of a newly approved drug must remain highly watchful.