ISSN: 2249–9504
CAS CODEN: IJPCDX

COMPARATIVE STUDY OF REGULATORY REQUIREMENTS FOR THE COMPILATION AND APPROVAL OF DOSSIER; AS PER CTD, ACTD AND ECTD FORMATS

Abstract

Author(s): Sunil L. Harer1*, Yuvraj D. Aher2, Vikas S. Kokane3 and Priyanka A. Sonar 4

This present article discusses the rules & regulations which are followed for drug approval process in USA, Europe & ASIAN country and India. Data required for the compilation of the dossier for various countries include the formats like CTD, e-CTD and ACTD.Regulatory affairs as a profession have important positions to play in positively impacting medication policy, use, results and other aspects of medical proper care. In many such cases this will be through cooperation and support with other wellness care professionals at a community stage. Pharmaceutical product approval process should be a critical step in ensuring access to safe and effective drugs. If performed, they will result in added value to medication treatment and development by making a beneficial participation to the safe, inexpensive and affordable use of drugs, leading to significant resources and results and improve the growth of the industry. Obtain and maintain medication records, results and relevant wellness details, if they do not already exist. These detailsare essential to evaluate personalized medication treatment. Identify, develop, evaluate and assess: Medication related problems, Symptoms described by patients, selfdiagnosed conditions. Implementation of CTD is expected to significantly reduce time and resources needed by industry to compile applications and reports for global registration. The pharmacologist must use his clinical reasoning and data to determine the stage of drug proper care and effects that is needed for each patient.

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