Monday , 22 April 2024

Observations on Guidelines for Post Marketing Surveillance for Pharmaceuticals

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

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.

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