Drug regulation in the future from the point of view of the industry

Abstract

Registration work can be defined as the act of collating all available relevant information from a drug development programme, and presenting it in such a way as to simplify as far as possible the assessment of quality, safety and efficacy. The determination of what information goes into the data package is much more of an art. One has to consider not only the science of the drug itself, but also the current needs of the drug regulatory authorities for the particular drug type and the likely requirements in 2–5 years’ time, when the drug reaches the registration stage. The term ‘registrology’ has been coined for this aspect of predicting registration requirements. It might have a finer scientific basis than astrology, but there can still be a strong element of crystal gazing in this scientific art. Thus the situation can be summed up as follows: Registration: Collation of all data for assessment of quality, safety, and efficacy. Registrology: Determination and prediction of data requirements for registration and beyond. In this paper I attempt to look into the future to see how the regulatory control of medicines might change over the next 10 years or so. Current trends in the regulatory scene are examined and projected towards the outcome of those trends; much more difficult is to endeavour to predict changes for which trends are at present not yet identified.