INTERNATIONAL CONFERENCE ON HARMONISATION: AN OVERVIEW
Journal Title: International Journal of Drug Regulatory Affairs - Year 2014, Vol 2, Issue 3
Abstract
The International Conference on Harmonisation (ICH) is a project that makes together the regulatory bodies of Europe, Japan and the United States and professionals from the pharmaceutical domain in the three areas to discuss scientific and technical views of medicinal product registration. The one aim of ICH is to reduce the need to repeat the testing carried out during the R &D of new Pharmaceuticals by suggesting ways to attain greater harmonisation in the interpretation and application of technical guidelines and requirements for Pharmaceuticals registration. Harmonisation would lead to a more frugal use of human, animal and material resources, and the evacuation of unnecessary time lag in the global development and availability of new Pharmaceuticals while maintaining safeguards on quality, safety, and efficacy, and regulatory duties to protect public health.
Authors and Affiliations
Chaitanya Prasad Kolla
Keywords
Related Articles
- EP ID EP349823
- DOI 10.22270/ijdra.v2i3.138
- Views 106
- Downloads 0
A PARADIGM SHIFT IN DRUG REGULATIONS IN TAIWAN
Across Asia, a convergence of economic trends, government policies and greater awareness among the general public of healthcare issues has created an environment that is poised for dramatic growth and change. Taiwan, for...
EMERGING TRENDS IN ORAL BIOAVAILABILITY ENHANCEMENT
Oral route is one of the most accepted and convenient mode of drug administration, however low oral bioavailability of many drugs is a major concern which limits their oral administration. Optimum solubility and permeati...
Regulation of Blood and Blood products in India, USA and EU
Blood and blood products are precious commodity which gives life to another person. Though we have immense discoveries and invention in science and technology, yet we cannot make blood hence, human blood has no substitut...
COMMON DEFICIENCIES RAISED BY VARIOUS REGULATORY AGENCIES
Timely Product registration is a challenge in today’s scenario. Regulatory agencies are keen in assessing CTD sections like redefining starting material of Drug substance manufacturing, Pharmaceutical development, impuri...
COMPARATIVE STUDY OF REGULATORY REQUIREMENTS AND REGISTRATION PROCESS OF GENERIC DRUGS IN JAPAN AND CHINA
A Generic Product must meet the standards established by Pharmaceutical Medical Device Agency (PMDA) & China Food and Drug Administration (CFDA) to be approved for marketing in Japan and China respectively. This study co...