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INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2456-4184 | Impact factor: 8.76 | ESTD Year: 2016 Scholarly open access journals, Peer-reviewed, and Refereed Journals, Impact factor 8.76 (Calculate by google scholar and Semantic Scholar | AI-Powered Research Tool) , Multidisciplinary, Monthly, Indexing in all major database & Metadata, Citation Generator, Digital Object Identifier(DOI) |
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| Paper Title: | “A Review Role Of Regulatory Agencies In The World For Controlling The Quality Of Medicines” |
| Authors Name: | Mr. Rushikesh S. Sarode , Mr. Dnyaneshwar B. Hardas , Mr. Pramod M. Bhosale |
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IJNRD_191892
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| Published Paper Id: | IJNRD2304382 |
| Published In: | Volume 8 Issue 4, April-2023 |
| DOI: | |
| Abstract: | Drugs are crucial for saving lives, preserving health, preventing diseases, halting epidemics, and boosting a nation's economy. As a result, the cost of pharmaceuticals is borne by the general public, government, pharmaceutical industry, and research institutions. However, for this to happen, the medicine must be high-quality, reliable, and safe. In order to ensure that medications are developed, produced, imported, exported, and distributed in accordance with established standards, there are regulations in place. Governments create powerful National Regulatory Authorities (NRAs) to ensure that pharmaceutical products are adequately regulated, thereby preserving and advancing public health. Global pharmaceutical rules are essential for ensuring the efficacy, quality, and safety of the medicines. The responsibility for enforcing laws and issuing guidelines for medication development, licencing, registration, production, labelling, storage, marketing, distribution, drug pricing, import, and post-marketing research on pharmaceutical products falls on the shoulders of the pharmaceutical regulatory agency. Pharmaceutical businesses that are interested in the global market must adhere to the various regulatory requirements of other nations' pharmaceutical laws. It is challenging to develop a single regulatory strategy for a drug product's Marketing Authorization Application (MAA) that is relevant to numerous nations. As a result, the Common Technical Document (CTD) was created to offer a standard structure for electronic filing of applications for the registration of pharmaceuticals. This review article provides an outline of the pharmaceutical regulatory bodies in India, the United States, and Europe. |
| Keywords: | WHO, Regulatory Agency ,CDSCO, US FDA, EMA, MHRA, TGA, ICH guidelines |
| Cite Article: | "“A Review Role Of Regulatory Agencies In The World For Controlling The Quality Of Medicines”", International Journal of Novel Research and Development (www.ijnrd.org), ISSN:2456-4184, Vol.8, Issue 4, page no.d588-d602, April-2023, Available :http://www.ijnrd.org/papers/IJNRD2304382.pdf |
| Downloads: | 000118761 |
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2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar| ESTD YEAR: 2016 An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.76 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator |
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Published Paper ID:IJNRD2304382 Registration ID: 191892 Published In: Volume 8 Issue 4, April-2023 DOI (Digital Object Identifier): Page No: d588-d602 Country: Jalna, Maharashtra, India Research Area: Pharmacy Publisher : IJ Publication Published Paper URL : https://www.ijnrd.org/viewpaperforall?paper=IJNRD2304382 Published Paper PDF: https://www.ijnrd.org/papers/IJNRD2304382 |
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ISSN: 2456-4184
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