PREPARATION AND REVIEW OF CHEMISTRY, MANUFACTURING AND CONTROL (CMC) SECTIONS OF CTD DOSSIER FOR MARKETING AUTHORIZATION
Journal Title: International Journal of Drug Regulatory Affairs - Year 2017, Vol 5, Issue 2
Abstract
The present article summarizes & simplify the marketing application requirements i.e. the critical aspects of marketing application in different CTD using countries, Process to prepare and review the requirements for CMC section (Chemistry manufacturing & Control) for filing an application in regulated market. Study shows the compilation of dossier as per CTD format with minimum errors during filing. The focus is on the application filing & Query part that may come after submission & during approval process. So one has to focus on the requirements of dossiers with minimal queries & study the probable queries that may arise after filing an application to regulated countries. Once approved, the applicant can market the safe, effective, stable & quality generic drug product with low cost to the public. The complete marketing application is based as per CTD format gives understanding of critical aspects of Marketing Application and better understanding of dossier filing.
Authors and Affiliations
Dhruvi H. Patel, Jitendra Kumar Badjatya, Amit A Patel
PATENT V/S MONOPOLY-A CASE STUDY
Provisions of Compulsory License balance this law between interest of Inventor & public as through these provisions License can be provided to others if the invention did not use sufficiently for Public. In case of medic...
EFFECTS OF PH, SALT, TEMPERATURE ON CONVENTIONAL LIPOSOMES SIZE ENLARGEMENT ANALYZED BY OPTICAL MICROSCOPE
The objective of the present study was to investigate the effects of experimental conditions like pH, salt, temperature on the interactions of conventional liposomes. The model drug Stavudine was entrapped in the liposom...
Regulatory overview of biosimilars in Europe
A biosimilar is a biological medicine similar, but not identical, to an already registered reference bio therapeutic product in terms of quality, safety, and efficacy. These drugs are also called as biosimilar products„,...
Overview of current Regulations governing Medical Devices
Medical Device (MD) is one of the fastest growing sector and so are the associated regulations. From lack of even policies and guidelines to stringent MD legislations in others, the requirements vary across countries. Un...
INTERNATIONAL CONFERENCE ON HARMONISATION: AN OVERVIEW
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 dis...