Abstract

ROLE AND OVERVIEW OF DRUG REGULATORY AFFAIRS IN PHARMACEUTICAL INDUSTRY WITH IMPLEMENTATION OF CTD AND ECTD

Sonali P. Mahaparale* and Bhakti R. Desai

Abstract

Drug Regulatory affairs is a vital unit in a pharmaceutical Industry. As the Pharmaceutical sector is rising very rapidly, there is a need of regulatory affairs professionals to provide the current needs of industries for the global competition. Drug Regulatory affairs professionals are the crucial link between pharmaceutical industries and worldwide regulatory agencies. Pharmaceutical product approval process should be a critical step in ensuring access to safe and effective drugs. Central Drugs Standard Control Organization (CDSCO), India has decided to adopt CTD format for technical requirements for registration of pharmaceutical products for human use. Implementation of CTD is expected to significantly reduce time and resources needed by industry to compile applications for global registration. This present article discusses the evolution of Drug Regulatory Affairs, its role in Pharmaceutical industry and its involvement for the implementation of CTD guidelines to regulate the marketing of the drugs and improve the growth of the industry.

Keywords: Regulatory Affairs, Regulatory Agencies, ICH guidelines, Drug Approval Process, CTD, eCTD.