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
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
The United States Department of Health and Human Services has a federal agency called the Food and Drug Administration (FDA or USFDA). A pre-planned assembling of two or more people who have been together for the purpose...
FORMULATION AND EVALUATION OF FAST DISINTEGRATING LOSARTAN POTASSIUM TABLETS BY FORMAL EXPERIMENTAL DESIGN
In the treatment of hypertension fast onset of action is the major concern. The problem of slow onset of action of drugs can be overcome by development of appropriate dosage forms. Fast disintegrating tablets in mouth ar...
This article states requirement of Marketing Authorization Application to get registration of Drug Product to EEA. The procedures for application of marketing authorization are: Centralised procedure, National procedure,...
RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF TELMISARTAN IN BULK AND TABLET DOSAGE FORM
A simple, sensitive, precise and specific reverse phase high performance liquid chromatographic method was developed and validated for the determination of Telmisartan in bulk and tablet dosage forms. It was found that t...
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...
How To Cite
Dhruvi H. Patel, Jitendra Kumar Badjatya, Amit A Patel (2017). PREPARATION AND REVIEW OF CHEMISTRY, MANUFACTURING AND CONTROL (CMC) SECTIONS OF CTD DOSSIER FOR MARKETING AUTHORIZATION. International Journal of Drug Regulatory Affairs, 5(2), 1-12. https://europub.co.uk/articles/-A-326700