Regulatory affairs in the pharmaceutical industry:
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| Other Authors: | , |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
London ; San Diego, CA ; Cambridge, MA ; Oxford
Academic Press
[2022]
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| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | xvi, 269 Seiten Illustrationen |
| ISBN: | 9780128222119 0128222115 |
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Contents List of contributors Editor biographies Preface 1. Drug regulatory affairs: an introduction xi xiii XV 1 Patent certifications Trademark registration Copyright registration Design registration in pharmaceutical context 1.5 Conclusion References 1.4.9 1.4.10 1.4.11 1.4.12 27 27 28 29 29 29 Jasjeet Kaur Narang, Anmol Dogra, Javed AH, Sanjula Baboota and Harmanpreet Singh 1 Introduction 1.1.1 Reason for the requirement of a drug regulatory department in the pharmaceutical industry 2 1.1.2 Responsibilities and duties of Drug Regulatory Affair professionals 2 1.1.3 Different regulatory agencies regulating pharmaceutical industries worldwide 4 1.2 Pharmaceutical regulatory affairs: documentation 6 1.2.1 Dossiers 6 1.2.2 Drug master file 9 1.2.3 Master formula record 12 1.2.4 Batch manufacturing formula record 13 14 1.2.5 Distribution record 1.3 Applications filed by the Drug Regulatory 14 Affairs department 1.3.1 Investigational new drug application 15 1.3.2 New drug application 16 1.3.3 Abbreviated new drug application 19 1.4 Hatch-Waxman Act and amendments 21 1.4.1 OrangeBook 22 1.4.2 Biologies license application 23 1.4.3 Marketing Authorization Application 24 1.4.4 Scale-up, process approval changes, 24 and postmarketing surveillance 1.4.5 Food and Drug Administration Modernization Act 25 1.4.6 Postmarketing surveillance 25 1.4.7 Good manufacturing practice certification 26 1.4.8 Application for getting a certificate of pharmaceutical product 26 1.1 2. Regulatory requirement for the approval of novel, nanotechnology 31 based biological products Shobhit Kumar, Javed
AH and Sanjula Baboota 2.1 Introduction 2.2 Regulatory requirements and active pharmaceutical ingredients approval process 2.2.1 Registration of active pharmaceutical ingredients 2.2.2 Drug master file 2.2.3 Recent changes in the drug master file rules 2.2.4 Responsibilities of active pharmaceutical ingredients manufacturer 2.2.5 Letter of access 2.2.6 Regulatory requirement for drug approval in the United States 2.3 Novel drugs and their regulatory requirements 2.3.1 Rules for approval of novel drugs 2.3.2 Approaches for approval 2.3.3 CDSCO and rules for novel drug marketing 2.4 Guidelines on approval of novel drug delivery systems 2.5 Regulation for nanotechnology products 2.5.1 FDA's methodology for various product classes 2.5.2 Data required for nanopharmaceuticals evaluation 2.6 Biologies and its regulatory guidelines 31 31 33 33 33 34 34 34 38 39 39 40 40 40 41 41 43 vii
viii Contents 2.6.1 International standards for regulation of biologies 2.6.2 U.S. Food and Drug Administration biologies team 2.6.3 Postlicensing monitoring 2.7 Conclusion References 3. International Council for Harmonisation (ICH) guidelines 43 44 44 45 45 47 Bhavna, Abhijeet Ojha and Samir Bhargava Introduction 3.1.1 Opportunities and difficulties 3.1.2 History of ICH 3.1.3 Progression of ICH harmonization 3.2 Outlines of ICH guidelines 3.2.1 Quality guidelines 3.2.2 Safety guidelines 3.2.3 Efficacy guidelines 3.2.4 Multidisciplinary guidelines 3.3 Conclusion References 3.1 4. Regulatory affairs for chemistry, manufacturing, and controls 47 47 47 49 50 51 61 63 66 72 72 75 Sonal Gupta, Sanjula Baboota, Javed AH and Shweta Dang 4.1 Introduction 4.2 Chemistry, manufacturing, and controls submission at investigational new drug (IND) stage 4.3 Chemistry, manufacturing, and controls submission at new drug application (NDA) stage 4.4 CMC changes and maintaining the CMC regulatory compliance 4.5 Combination product regulations 4.5.1 Premarket review process 4.5.2 Marketing application 4.6 Medical devices regulations 4.7 Conclusion References 5. Global submissions for drug approvals 6. Regulatory requirements of regulated market 97 100 102 102 105 105 105 105 106 106 106 106 107 107 107 107 108 108 108 109 113 76 Sandesh Lodha, Hetal Patel, Shrikant Joshi, Gajanan Kalyankar and Ashish Mishra 77 78 81 83 83 84 86 86 89 Global submissions 5.1.1 Introduction 5.1.2 Drug approval in the United States 93 75 Shrestha Sharma, Syed Arman Rabbani and Rajesh Sharma 5.1 5.1.3 Drug approval
in Europe and United Kingdom 5.1.4 Investigational medicinal product dossier 5.1.5 Drug approval process in Australia 5.1.6 Drug approval in Japan 5.1.7 Approval of new drug in India 5.2 Common technical document 5.2.1 Module 1: general information 5.2.2 Module 2: CTD summaries 5.2.3 Module 3: quality 5.2.4 Module 4: nonclinical study reports 5.2.5 Module 5: clinical study reports 5.3 Investigator's brochure 5.3.1 General considerations 5.3.2 Purpose of an Investigator's Brochure 5.3.3 Aims of an Investigator's Brochure 5.3.4 Revision of an Investigator's Brochure 5.3.5 Contents of Investigator's Brochure 5.3.6 Summary of data and guidance for the investigator 5.3.7 Regulation of Investigator's Brochure 5.4 Conclusion References 89 89 90 Introduction Marketing authorization of pharmaceuticals in the EU 6.2.1 Introduction 6.2.2 Steps before submission of application (EMA/821278/2015) 6.2.3 Submission of the application 6.2.4 Evaluation of the application 6.2.5 Decision on marketing approval 6.2.6 Assigning new marketing approval number and product information requirements 6.2.7 Withdrawal of MAA 6.2.8 Marketing approval: biosimilar medicines 6.2.9 Marketing approval: generic and hybrid applications 6.2.10 Marketing approval: pediatrics 113 113 113 115 116 117 118 119 120 120 121 124
Contents Pediatric-use marketing authorizations Marketing authorization of pharmaceuticals in the United Kingdom 6.3.1 Application process 6.3.2 Product license number 6.3.3 Active substance master files 6.3.4 Summary of product characteristics 6.3.5 Providing a name for your medicine 6.3.6 Fast track your marketing authorization 6.3.7 Payments 6.3.8 Rejection Marketing authorization of pharmaceuticals in the United States 6.4.1 Introduction 6.4.2 Marketing of veterinary products in the United States Marketing authorization process for Japan 6.5.1 New drug application 6.5.2 Generic drug approval process 6.5.3 Orphan drug regulation in Japan 6.5.4 Biological product approval in Japan Marketing authorization for pharmaceuticals in Australia 6.6.1 Introduction 6.6.2 Application for registering drug product 6.6.3 Registration of over-the- counter (OTC) medicine 6.6.4 Registration of complementary medicine Marketing authorization of pharmaceuticals in India 6.7.1 Introduction 6.7.2 Regulatory framework 6.7.3 Prohibition of importing and/or manufacturing of certain drugs or cosmetics 6.7.4 Import and manufacture of drugs for commercial use in India 6.7.5 Import and manufacturing of drugs for examination, testing, or analysis 6.7.6 Import or manufacture of novel homeopathic medicine 6.7.7 Selling, stocking, exhibiting, offering for sale, or distributing drugs (including homeopathic) in India 6.7.8 Manufacturing Ayurvedic, Siddha, or Unani medicine 6.7.9 Cosmetics 6.7.10 New drugs 6.2.11 6.3 6.4 6.5 6.6 6.7 6.7.11 Similar biologies 6.7,12 SUGAM portal 6.8 Conclusion References 125
125 125 125 125 126 126 7. Pharmaceutical regulatory requirements of nonregulated markets ix 156 158 158 158 163 G.N.K. Ganesh and Suresh K. Mohankumar 126 126 126 7.1 Introduction 7.2 Malaysia 7.3 Indonesia 7.4 Thailand 7.5 Vietnam 7.6 Philippine 7.7 Myanmar 7.8 Sudan 7.9 Uganda 7.10 Zimbabwe 7.11 Conclusion Acknowledgment References 126 126 131 132 132 133 133 134 134 134 135 139 141 144 144 145 145 145 148 148 148 148 148 149 8. Drug product performance and scale-up process approval changes 163 164 171 172 179 180 187 190 191 201 212 213 213 215 Gulam Mustafa, Md AH Mujtaba, Sabna Kotta, Abdullah Habeeballah, Nabil A. Alhakamy, Hibah Μ. Aldawsari. Shahid Karim and Shadab Md 8.1 Introduction 8.2 In vitro drug product performance 8.3 In vitro drug product performance evaluation 8.3.1 Disintegration test 8.3.2 Dissolution test 8.3.3 Dissolution profile comparisons 8.3.4 Dissolution specification for a new chemical entity 8.3.5 Dissolution specification for generic products 8.3.6 Biopharmaceutics classification system 8.4 In vivo performance 8.4.1 In vivo performance evaluation of generic drugs 8.5 Bioavailability and bioequivalence regulatory perspective 8.5.1 Design of bioequivalence studies 8.5.2 Drug interchangeability 8.5.3 Practical issues 8.6 In vitro-in vivo correlation 8.6.1 Advantages of IVIVC 215 215 216 216 216 219 220 220 221 221 222 223 223 225 225 226 226
X Contents 8.6.2 Drawbacks associated with IV1VC 8.6.3 Criteria and classification of MVC 8.6.4 Biowaivers 8.7 Scale-up and postapproval changes 8.7.1 EMA guidelines 8.7.2 US FDA guidelines 8.8 Conclusion References 9. Regulatory affairs in clinical trials 226 226 228 229 229 232 236 236 241 Mohammad Ahmed Khan, Sadat Shafi, Syed Sufian Ahmad and Faraha Ahmed 241 9.1 Introduction 241 9.2 Regulatory submissions of new drugs 9.2.1 Role of regulatory professionals in 242 regulatory submissions 9.3 Clinical trial regulation in regulated markets: the United States, Japan and 242 Europe 9.4 Regulatory collaboration: developing 244 new reliance model 9.5 Harmonization of clinical trial regulation: 244 principles of ICH-GCP 9.6 Clinical trial protocol 246 9.6.1 Significance of clinical trial protocol 246 247 9.7 Ethical aspect of clinical trial 9.7.1 Informed consent form 247 9.7.2 Exceptions to informed consent 248 249 9.8 Protection of human subjects 9.8.1 The common rule 249 9.8.2 Institutional review board 250 9.9 Investigator's brochure 251 9.9.1 Contents of investigator's brochure 251 9.10 Clinical trial: quality assurance 253 9.10.1 Good clinical practice: requirement of quality clinical trial 253 9.11 Safety monitoring in clinical trials 254 9.11.1 Role of Data and Safety Monitoring Board in monitoring safety in clinical trials 254 9.11.2 Role of regulatory authorities in monitoring safety of clinical trials 254 9.11.3 Postmarketing surveillance (pharmacovigilance) 255 9.11.4 Postmarketing reporting of adverse experiences 255 9.12 Outsourcing of clinical trials 255 9.12.1
Contract research organizations 256 9.12.2 Outsourcing of bioavailability and bioequivalence studies 256 9.13 Health Insurance Portability and Accountability Act 257 9.13.1 HIPAA compliance in clinical trials 257 259 9.14 Conclusion References 259 Index 263 |
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| spelling | Regulatory affairs in the pharmaceutical industry edited by Javed Ali (Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India), Sanjula Baboota (Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India) London ; San Diego, CA ; Cambridge, MA ; Oxford Academic Press [2022] xvi, 269 Seiten Illustrationen txt rdacontent n rdamedia nc rdacarrier Regulierung (DE-588)4201190-5 gnd rswk-swf Pharmazeutische Industrie (DE-588)4045696-1 gnd rswk-swf Drugs / Law and legislation Pharmacy / Law and legislation Pharmaceutical industry Pharmaceutical policy Drug Industry Industrie pharmaceutique Médicaments / Politique gouvernementale Pharmazeutische Industrie (DE-588)4045696-1 s Regulierung (DE-588)4201190-5 s DE-604 Ali, Javed edt Baboota, Sanjula edt Digitalisierung UB Passau - ADAM Catalogue Enrichment application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=033578673&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
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| title | Regulatory affairs in the pharmaceutical industry |
| title_auth | Regulatory affairs in the pharmaceutical industry |
| title_exact_search | Regulatory affairs in the pharmaceutical industry |
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| title_full | Regulatory affairs in the pharmaceutical industry edited by Javed Ali (Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India), Sanjula Baboota (Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India) |
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| title_full_unstemmed | Regulatory affairs in the pharmaceutical industry edited by Javed Ali (Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India), Sanjula Baboota (Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India) |
| title_short | Regulatory affairs in the pharmaceutical industry |
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