ABSTRACT
It takes about 12 years from first synthesis of a new molecule in the chemistry laboratory to the granting of marketing authorisation and the launch of a new drug. On average, six years are spent in basic pre-clinical research (chemistry, pharmacy, biology, pharmacology, toxicology) and a further six years in clinical development. Since the patent life of a newlydiscovered molecule is 20 years, only a limited number of years is available for a drug manufacturer to make profits from marketing a successful new drug. After the patent expires, other companies are allowed to market generic copies without having to invest in the enormously expensive research and development programme which first brought the drug into clinical use. All pharmaceutical companies are therefore looking for ways to speed up the drug development process, and try to get the cooperation of everyone, including the clinical investigators, in making the process quick and smooth. Many companies, particularly the large ones, are now aiming to shorten the interval between molecular discovery and marketing authorisation to five or six years.
