ABSTRACT:
Drug regulatory affairs are an important part of the pharmaceutical industry. As usual The pharmaceutical industry is growing very fast, and there is a need Regulatory affairs experts to meet current needs industry for global competition. Drug Regulatory Affairs Specialists are an important link between the pharmaceutical industry And regulatory agencies around the world. Drug product approval Should be an important step to ensure that the process is safe and effective Drug. Central Narcotics Control Organization (CDSCO), India Decided to adopt the CTD format for the technical requirements for Registration of medicinal products for human use. Implementation CTD is expected to significantly reduce the time and resources required By industry to prepare applications for global registration. In this article Evolution of Drug Regulatory Issues, Roles and Relationships in the Pharmaceutical Industry to implement CTD guidelines to regulate and improve drug marketing industrial development.
Cite this article:
Dhananjay D. Chaudhari, Mohit R. Koli. Drug Regulatory Affairs: Short Review. Asian Journal of Research in Pharmaceutical Sciences. 2023; 13(1):73-6. doi: 10.52711/2231-5659.2023.00014
Cite(Electronic):
Dhananjay D. Chaudhari, Mohit R. Koli. Drug Regulatory Affairs: Short Review. Asian Journal of Research in Pharmaceutical Sciences. 2023; 13(1):73-6. doi: 10.52711/2231-5659.2023.00014 Available on: https://ajpsonline.com/AbstractView.aspx?PID=2023-13-1-14
REFERENCE:
1. https://www.slideshare.net/DipakBhingardeve/regulatory-affairs-238230245
2. https://www.sciencedirect.com/topics/medicine-anddentistry/regulatoryaffairs#:~:text=The%20regulatory%20affairs%20(RA)%20department,the% 20product%20on%20the%20market.
3. https://www.internationaljournalssrg.org/IJPBE/2016/Volume3- Issue1/IJPBE-V3I1P101.pdf
4. https://www.linkedin.com/pulse/regulatory-affairs-its-rolepharmaceutical-industry-numra
5. https://www.worldwidejournals.com/global-journal-for-research-analysisGJRA/recent_issues_pdf/2018/January/January_2018_1515152068__76.p df
6. https://wjpr.s3.ap-south-1.amazonaws.com/article_issue/1522475057.pdf
7. https://www.researchgate.net/publication/301637817_Drug_Regulatory_Agencies_In_India_USA_Europe_And_Japan-A_Review/link/571f57d908aefa64889a7182/download
8. http://webstor.srmist.edu.in/web_assets/srm_mainsite/files/downloads/Responsibilities_of_Regulatory_authority.pdf
9. https://www.researchgate.net/publication/357649862_Current_Scenarios_On_Regulatory_Landscape_Of_Indian_Pharmaceutical_Industries/link/61d823d2e669ee0f5c8db757/download
10. http://shodhganga.inflibnet.ac.in/bitstream/10603/114212/6/chap
11. Avhad P: The Indian pharmaceutical industry: The “pharmacy of the world‟?. Available from: https://www. Farmavita.net/documents/Indian Pharmaceutical Industry.