COMMON DEFICIENCIES RAISED BY VARIOUS REGULATORY AGENCIES
Journal Title: International Journal of Drug Regulatory Affairs - Year 2014, Vol 2, Issue 2
Abstract
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, impurities in Drug substance and Drug product, Container-closure. Common deficiencies are presented in this article.
Authors and Affiliations
Mohidekar S, Maharao V, Badjatya J. K.
Keywords
Related Articles
- EP ID EP345402
- DOI 10.22270/ijdra.v2i2.125
- Views 101
- Downloads 0
Regulatory requirements for the approval of Anti-Cancer drug (Mercaptopurine) in Myanmar as per ACTD
South East Asian pharmaceutical market is growing rapidly. In Asian country, the regulatory environment is similar among all countries. But still requirements and process of registration is varying among countries of Asi...
Comparative study of the harmonization of pharmaceutical regulations in the western and central sub-regions of Africa
The harmonization of pharmaceutical regulations in Africa aims to offer States a coherent body of texts and practices by combining limited resources. The objective of this study was to describe policies to harmonize phar...
ADVANCES IN THE REVIEW OF GENERIC DRUG APPLICATIONS BY UNITED STATES FOOD AND DRUG ADMINISTRATION, A REGULATORY PERSPECTIVE IN THE ERA OF GDUFA (GENERIC DRUG USER FEE AMENDMENT 2012)
A regulatory process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. The United States - Food and Drug Administration (U.S. FDA) has...
A SNAP-SHOT OF FIRST-LINE ART TREATMENT FAILURE CASES FROM MPUMALANGA PROVINCE ON THE DECENTRALISED PHARMACOVIGILANCE PROGRAMME DATABASE
The increase in ART use comes with the inevitable increase in cases of ART treatment failure, especially that patients are living longer on ART. The main objective of this short study was to conduct an interim review of...
COMPARISON OF GLOBAL REGULATORY GUIDELINES FOR AVAILABILITY OF DIFFERENT BIOWAIVER PROVISIONS AND APPLICATION REQUIREMENTS OF BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS) BASED BIOWAIVER.
To waive a complete and systemic Bioequivalence (BE) study, Biowaiver or Request for a Biowaiver is a fast track approach to boost the drug development process. Over the past three-four years the Biowaiver market shows g...