World Journal of
Pharmaceutical and Life Sciences

TECHNICAL STEPS AND CHALLENGING DECISIONS DURING REGISTRATION OF DRUG PRODUCTS

K. Prasanna Teja, D. Nagarjuna Reddy*, M. V. Nagabhushanam, Konda Ravi Kumar and Munagala Gayatri Ramya

ABSTRACT

Regulatory Affairs in the Parma Industry may be defined as "The interface between the pharmaceutical company and the regulatory agencies across the world." Regulatory affairs is a comparatively new profession which developed from the desire of governments to protect public health by controlling the safety and efficacy of products[1-6] in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. Regulatory agency in the present context may be defined as "The competent government agency which is responsible for ensuring that medicines work and are acceptably safe."

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