About Authors:
Geetanjali Sengar*, Pranab Tripathy
Drug Regulatory Affairs Dept.
Belco Pharma, 515, Modern Industrial Estate,
Bahadurgarh-124507(Haryana), India.
*geetanjali.sengar@gmail.com, geetanjalisengar87@gmail.com
ABSTRACT:
As the pharmaceutical industries throughout the world are moving ahead towards becoming more and more competitive, regulatory agencies are being established in various countries across the globe. Regulatory agencies and organizations play a vital role to meet the requirements of legal procedures related to drug development process in a country.
In the present scenario, pharmaceuticals are considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate drug development process,licensing, registration, manufacturing, marketing and labeling of pharmaceutical products. USFDA(USA), MHRA(UK), TGA(Australia), CDSCO(India), HEALTH CANADA(CANADA), MCC(South Africa),ANVISA (Brazil) , EMEA (European Union), SFDA (China),NAFDAC(Nigeria), MEDSAFE(Newzeland), MHLW(Japan), MCAZ(Zimbabwe), SWISSMEDIC(Switzerland), KFDA(Korea), MoH (Sri Lanka) are the few regulatory agencies and organizations established in respective countries.