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International Journal for Research Trends and Innovation
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ISSN Approved Journal No: 2456-3315 | Impact factor: 8.14 | ESTD Year: 2016
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Impact Factor : 8.14
Issue per Year : 12
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| Paper Title: | REGULATORY AFFAIRS IN PHARMACEUTICAL INDUSTRIES |
| Authors Name: | Umesh Indrajit Kale , Nikita Dadasaheb Shinde , Pratiksha Prashant Bombale , Rutuja Raju Khandale , Shital Tanaji Khandagale |
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| Author Reg. ID: |
IJRTI_186225
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| Published Paper Id: | IJRTI2304191 |
| Published In: | Volume 8 Issue 4, April-2023 |
| DOI: | |
| Abstract: | Regulatory Affairs Professionals Are Responsible For Maintaining Product Compliance And Maintaining All Records. Pharmaceutical Regulations Are Necessary To Ensure The Quality, Safety And Efficacy Of Medicines. Even A Small Error Can Result In A Product Recall And Cost Millions Of Dollars. Regulation Affects All Aspects Of The Pharmaceutical Industry. The Marketing Authorization Holder, Including The Terms "Marketing Authorization Holder" And "Person Responsible For Placing The Medicinal Product On The Market", Must Be Established Within The EEA. The MA Can Be Granted To Applicants According To The Following Procedures: National Procedure, Decentralized Procedure, Mutual Recognition Procedure, Centralized Procedure CTD Stands For Common Technical Document And Is An Internationally Recognized Format For Preparing Well-Structured Submissions Applications Must Be Submitted To The Regulatory Authorities Of The Three ICH Regions (Europe, United States And Japan)..The Main Objective Is To Prepare And Validate A Complete File In CTD Modules 1-5 Format For Submission In Europe And ORM. This Applies To All Types Of Applications - National, Centralized, MRP (Mutual Recognition Program) And DCP (Decentralized Program).Mutual Recognition Procedure: Thanks To The Mutual Recognition Procedure, The Product Is First Authorized By A European Country According To The National Procedure Of This Country. Then, Other Marketing Authorizations Can Be Requested From Other European Countries, Which Do Not Carry Out Their Own Review But Agree To Determine The Decision Of The First Country. |
| Keywords: | Pharmaceutical Drug Regulatory Affairs, Importance of Drug Regulatory Issues, Importance of Drug Regulatory Issues, History Of Regulatory Affairs |
| Cite Article: | "REGULATORY AFFAIRS IN PHARMACEUTICAL INDUSTRIES", International Journal for Research Trends and Innovation (www.ijrti.org), ISSN:2455-2631, Vol.8, Issue 4, page no.1170 - 1173, April-2023, Available :http://www.ijrti.org/papers/IJRTI2304191.pdf |
| Downloads: | 000205240 |
| ISSN: |
2456-3315 | IMPACT FACTOR: 8.14 Calculated By Google Scholar| ESTD YEAR: 2016 An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.14 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: IJRTI2304191
Registration ID:186225
Published In: Volume 8 Issue 4, April-2023
DOI (Digital Object Identifier):
Page No: 1170 - 1173 Country: Solapur, Maharashtra, India Research Area: Pharmacy Publisher : IJ Publication Published Paper URL : https://www.ijrti.org/viewpaperforall?paper=IJRTI2304191 Published Paper PDF: https://www.ijrti.org/papers/IJRTI2304191 |
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ISSN: 2456-3315
Impact Factor: 8.14 and ISSN APPROVED,
Journal Starting Year (ESTD) : 2016
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