Regulatory Perspective on Technology Transfer

Abstract

Several stages of development are involved before a medicine comes into the market. They are mainly designed to demonstrate its safety and efficacy. These include research and development, pre-clinical studies, clinical studies and finally culminate in obtaining approval from the concerned regulatory authority. This process is generally costly and time consuming. Technology transfer plays a vital role in avoiding repetition of such development process. Globalization in the pharmaceutical industry demands a need for proper technology transfer. Proper knowledge and experience in technology transfer can lead to reduction in cost and wider availability of life saving drugs. Technology transfer aids to keep the acquired knowledge alive and promotes continued progress. Technology transfer is the transfer of knowledge along with its documentation from one company to another or between different sites of same company. This thesis throws light on the regulations related to technology transfer in pharmaceutical industry, mentioning the types of technology transfers, the requirements for successful technology transfer. It also highlights the role of the regulatory affairs department and necessity for its involvement from the start of the transfer rather than at the time of dossier filing. The regulatory gap analysis between India & Europe and documentation involved in the transfer is also discussed with an example.