Observations on Guidelines for Post Marketing Surveillance for Pharmaceuticals

M. Bhavana Priya¹, J. Praveen Kumar²
Department of Regulatory Affairs, Krishna Teja Pharmacy College, Tirupati.

A B S T R A C T
Some issues about healthy volunteer recruitment in first-in-man trials and reimbursement remain unresolved, and they can be summarized as follows: There is a lack of international consensus on the definition of healthy status, based on standard physical, psychological, and laboratory parameters, suitable for the enrolment of candidate subjects in first-in-man trials. There is a need for guidelines about appropriate advertisements addressed to potential participants in first- in-man clinical trials, to set out specific ethical limitations. There is a lack of international and/or local statements about standard criteria for offering fair payments to healthy volunteers enrolled in first-in-man trials. Based on current Italian regulations, there is a need for a national register to monitor the participation of healthy subjects in different early clinical trials at the same or different centres for drug experimentation. In view of a “new era of early phase trials,” the national legislation should offer Italian investigators conducting phase 0 and phase I trials a comprehensive guideline encompassing all principles sanctioned.