Drug approval process in India and Europe
Journal Title: International Journal of Drug Regulatory Affairs - Year 2019, Vol 7, Issue 1
Abstract
Every time a new drug is developed it requires a great amount of research work in manufacturing, Pre- clinical Science, Controls, Chemistry & Clinical trials. Regulatory agencies have Drug Reviewers who has the responsibility of checking that whether the data supports the Safety, Effectiveness and Quality control of a New Drug product to serve the public health. Every country has its own Regulatory agency which is responsible for regulating all the Rules and Regulations and forms the guidelines for regulating the Manufacturing, Processing and Marketing of the Drugs. This Article focuses on Drug Approval Process in Europe and India.
Authors and Affiliations
S P Yamini Kanti, Ildiko Csoka, Amrish Chandra, Vikesh Kumar Shukla
Keywords
Related Articles
- EP ID EP495760
- DOI 10.22270/ijdra.v7i1.304
- Views 80
- Downloads 0
A COMPARISON OF NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES ACT WITH DRUGS AND COSMETICS ACT: SALIENT DIFFERENCES
This article assesses the comparison of Narcotic Drugs and Psychotropic Substances Act (NDPS Act) with the Drug and Cosmetic Act (D & C Act) and also point out the salient features of NDPS Act. Drugs and Cosmetics Act, 1...
THE PATH OF PERSONALIZED MEDICINE: REGULATORY PERSPECTIVE
Personalized medicine (PM) has become a topic of great interest because of its potential to improve patient care and optimize therapeutic strategy. The way we understand and treat disease is changing rapidly. The traditi...
SIMULTANEOUS UV SPECTROPHOTOMETRIC METHODS FOR ESTIMATION OF CEFADROXIL AND PROBENECID IN TABLET DOSAGE FORM
Two methods for simultaneous estimation of Cefadroxil and Probenecid in combined tablet dosage form have been developed. The first UV spectrophotometric method was a determination using the simultaneous equation method a...
QUALITY STANDARDS FOR MEDICAL DEVICES
Formerly with more augmented disabilities, Medical devices have become decisive device in many circumstances. As these are more perilous, the manufacturer should endow with an ideal medical device in aspects of safety &...
SOFTWARE AS MEDICAL DEVICE
The use of software in a medical device allows the manufacturer to concentrate on the application needed to run device-specific functions. The medical device manufacturer using software generally neglect software life cy...