A Review on regulatory affairs and regulatory requirements for drug approval

Abstract

Regulatory affairs are a new profession that can be developed for the controlling the safety, quality and efficacy of the drug products by submitting the investigational new drug application (IND) and new drug application (NDA) to regulatory authority. The whole process may be done in conscious manner in order to release a safe drug product to protect the public from toxic effects of drugs during and after the usage of drugs. The main intention of this article was to aware the peoples towards the role of regulatory affairs department, requirements for new drug approval and the involvement of the regulatory professionals in this process as well as how crucial it is to perform and monitor the clinical and nonclinical trials of the drug before marketing the drug.