Design and development review: At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements— (a) to evaluate the ability of the results of design and development to meet requirements; and (b) to identify any problems and propose necessary actions. Participants in such reviews shall include representatives of functions concerned with th ...

INTRODUCTION 1. A number of communicable as well as non-communicable diseases place heavy burdens in terms of morbidity and mortality, and economic losses, onto the populations and health systems of the country. 2. In order to address the disease burden, it is of paramount importance that safe and effective new drugs are developed and available for prevention and treatment of various diseases. 3. ...