August 2017 ARTICLE LIST >>
PharmaTutor (August - 2017)
ISSN: 2347 - 7881
(Volume 5, Issue 8)
Received On: 24/04/2017; Accepted On: 02/05/2017; Published On: 01/08/2017
AUTHORS:
G. TarunKumarReddy*1, g. Naveen KumarReddy2
1*Department of Pharmaceutics and Drug regulatory affairs
AnnamacharyaCollege of Pharmacy,
Rajampet, Kadapa, Andhra Pradesh, India
2Department of Pharmaceutical analysis,
Sri PadmavathiSchool of Pharmacy,
Tiruchanoor, Chittoor, Andhra Pradesh, India
* gtarunkreddy@gmail.com
ABSTRACT:
The regulatory bodies are being established in various pharmaceutical industries across the globe which plays a vital role to meet the requirements of legal procedures related to drug development process in a country. The pharmaceutical industry is considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug. Countries possess their own regulatory authority, which is responsible for enforcing the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing, marketing, labeling and the product life cycle of pharmaceutical products. In an ever-changing regulatory environment, the role of regulatory affairs personnel is essential to ensure compliance with legislation in all regions in which a company wishes to distribute its drug. This article describes about the development of the drugs as it is a cumbersome process which includes several months of time, volunteers, and a huge finical investment majorly through the funding process, so it is strictly regulated as per the norms and regulations as given by those individual countries to carry out the drug development which were generally governed by the Drug Regulatory Affairs Personals.
How to cite this article: Reddy GTK, Reddy GNK; Significance of Pharmaceutical Regulatory Bodies - A Review; PharmaTutor; 2017; 5(8); 15-22
[ABSTRACT WITH CITATION] [VIEW AS HTML]
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