- Todos > Medicine Access and Rational Use > Selection
- Todos > Quality and Safety: Medicines > Safety and Efficacy
- Palabras clave > clinical evaluation
- Palabras clave > clinical trials conducted - new medicines approved/New Drug Application (NDA)
- Palabras clave > drug development process
- Palabras clave > drugs evaluation
- Palabras clave > essential medicines history
- Palabras clave > Essential Medicines List (EML)
- Palabras clave > new medicines - efficacy and safety
- Palabras clave > selection of medicines
- Palabras clave > WHO expert committee
- Palabras clave > WHO Model List of Essential Medicines
- Palabras clave > evaluación de medicamentos
(1975; 60 pages) [French] [Russian] [Spanish]
The introduction of a large numbers of new drugs during recent decades has caused concern among the medical profession, research workers in the drug field, and the public in regard to both safety and efficacy. But it was not until the tragic effects of thalidomide in the early 1960s that the procedures employed, which left evaluation of the safety and efficacy of drugs largely in the hands of the drug manufacturers and clinicians, were recognized as inadequate. Legislation governing the evaluation of both new and old drugs has now been adopted in many countries.
The manner in which the World Health Organization can contribute to an improvement in drug evaluation has been discussed at various sessions of the governing bodies of WHO. The present Group was convened to consider all aspects of the evaluation and testing of drugs in the light of increasing knowledge and to formulate proposals and guidelines for present and future research in the field.