Affiliation:
1. Amity Institute of Pharmacy, Amity University, Sector 125, Noida, 201301, Uttar Pradesh, India
Abstract
Abstract:
Regulatory affairs are one of the most crucial connections between the pharmaceutical
company and the other stakeholder’s or regulatory agencies such as FDA, EMA, etc. Strategies in
drug approval and marketing to assure the quality, safety, and efficacy of the drug follow the
guidelines and laws stated under the drug and cosmetic act 1940 and rules 1945. Their primary responsibility
is to keep the company in compliance with changing guidelines, which necessitates
constant monitoring of the most recent industry updates. Drug regulation is a complex process as
every country has its own set of documentation that must be done while regulatory submissions.
From drug development and drug approval to drug commercialisation, there is a large amount of
documentation that must be completed with accuracy, which can be challenging for the professional
to complete, therefore, this leads to the introduction of the concept of big data that can be incorporated
which will map the regulations according to 5vs model of big data. Thus, to make it more
efficient, we can work big data with artificial intelligence to ease the process using natural language
processing. This concept will map all the rules and guidelines together and make a cluster of
similar rules together. Now, users can use the tool to locate the data of interest in a single site in a
more comprised universal language that can be accessed by any professional to complete the task
in the given time schedule.
Publisher
Bentham Science Publishers Ltd.
Reference57 articles.
1. Laenen K.; The key role of regulatory affairs in the pharmaceutical industry: From drug development to commercialization, QbD Group Available from:
2023
2. ICH M4/The Common Technical Document (CTD): Comparison of Clinical Documents and Summaries Assessment Practices in the United States, Europe, and Japan. Available from: 2022
3. Aher R.; Aher P.; Ahire T.; Shahare H.V.; Nemade C.T.; Regulatory requirement and step for registration and approval of Indian drug products in overseas market. Int J Pharm Sci Rev Res 2021,68(2),54-62
4. Johnson T.; Joyner M.; DePourcq F.; et al. Using Research Metrics to Improve Timelines Proceedings from the 2nd Annual CTSA Clinical Research Management Workshop. Clin translat Sci 2010,3(6),305-8
5. Evangeline L.; Mounica N.V.; Reddy V.S.; Ngabhushanam M.V.; Reddy D.N.; Bonthagarala B.; Regulatory process and ethics for clinical trials in India (CDSCO). Pharma Innov 2017,6(4, Part C),165