[Contact and dialogue between drug companies and the global regulatory authorities throughout research and development phase]

Abstract

Contact between pharmaceutical companies and local as well as global regulatory authorities (Ministry of Health) takes place throughout the development phase and especially when a clinical study is to be initiated. This contact is important both for the company and for the authorities, as both parties are constantly kept informed about the development progress and about the potential unexpected findings in connection with development of a new drug. The authority dialogue secures that authorities and companies exploit their resources optimally and patients get access to new, safe and efficacious drugs without delay.