Introduction of Regulatory Affairs

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Information about Introduction of Regulatory Affairs

Published on April 2, 2013

Author: girishswami


PowerPoint Presentation: Girish Swami, (M.Pharm, PGDIPR, PGDDRA) International Regulatory Affairs Dept. +91-9881492626 Introduction of Regulatory Affairs Regulatory Affairs: Regulatory Affairs Role of RA: Role of RA To keep track of the ever-changing legislation Registration documents to regulatory agencies To give strategic and technical advice to R&D, Production, QC dept etc. You should know: You should know What is Dossier ? What is DMF ? What is CTD / eCTD ? What is NDA / ANDA and MAA ? What is Dossier ?: What is Dossier ? Dossier is a collection or file of documents that contains all the technical data of pharmaceutical product to be approved / registered / marketed in a country. It most commonly called as Registration Dossier , In US : New Drug Application (NDA), In EU : Marketing Authorization Application (MAA) What is DMF ? Drug Master File (DMF): What is DMF ? Drug Master File (DMF) US U nited S tate D rug M aster F ile ( US-DMF ) EU E uropean D rug M aster F ile ( EDMF ) or A ctive S ubstance M aster F ile ( ASMF ) Type I – Mfg. Site, Facilities, Operating Procedures, and Personnel (no longer applicable) Type II - DS, Intermediate & Material Used in Their Preparation or Drug Product Type III - Packaging Material Type IV - Excipient, Colorant, Flavor or Material Used in Their Preparation Type V - FDA Accepted Reference Information (FDA discourages its use) [ Applicant’s Part / Open Part and Restricted part / Closed part ] What is CTD/eCTD ?: What is CTD/eCTD ? C ommon T echnical D ocument ( CTD ): Its an format set by ICH which was agreed by the Regulatory Agencies of Europe , Japan & the US . Its electronic version called as e lectronic C ommon T echnical D ocument ( eCTD ). The CTD Triangle: The CTD Triangle CTD Modules: CTD Modules Module 1 – Administrative Information (Region Specific) Module 2 – CTD Summaries (QOS) Module 3 – Quality (CMC) Module 4 – Non-Clinical Study Reports Module 5 – Clinical Study Reports Module 1 Administrative Information (Region Specific): Module 1 Administrative Information (Region Specific) For USA Application form 356h Proposed label Patent certification / information Debarment certificate Letter of Authorization (LoA)/ DMF letter Labeling text For EU Application form Summary of product characteristics Labelling text and mock-ups Information about the experts Environmental risk assessment Description of the pharmacovigilance system Risk management plan Should contain documents specific to each region Module 2 CTD Summaries (QOS): Module 2 CTD Summaries (QOS) It contain 7 sections in the following order: 2.1 CTD TOC (Module 2-5) 2.2 CTD Introduction 2.3 Quality Overall Summary 2.4 Non-clinical Overview 2.5 Clinical Overview 2.6 Non-Clinical Summary 2.7 Clinical Summary Module 3 Quality (CMC): Module 3 Quality (CMC) 3.1 TOC of Module 3 3.2 Body of Data 3.2.S - Drug substance 3.2.P - Drug product 3.2.A - Appendices 3.2.R - Regional Information 3.3 Literature references Module 4 Non-Clinical Study Reports: Module 4 Non-Clinical Study Reports 4.1 TOC of Module 4 4.2 Study reports 4.2.1 Pharmacology 4.2.2 Pharmacokinetics 4.2.3 Toxicology 4.3 Literature References Module 5 Clinical Study Reports: Module 5 Clinical Study Reports 5.1 TOC of Module 5 5.2 Tabular listing of Clinical Studies 5.3 Clinical study reports 5.3.1 Reports of Biopharmaceutical (BA-BE) Study 5.3.2 Reports of Pharmacokinetic ( biomaterial ) study 5.3.3 Reports of Pharmacokinetic (PK) Studies 5.3.4 Reports of Pharmacodynamic (PD) Studies 5.3.5 Reports of Efficacy and Safety studies 5.3.6 Reports of Post-Marketing experience 5.3.7 Case Report Forms & Individual patient listings 5.4 Literature References eCTD: eCTD Its electronic version of CTD, so called as e lectronic C ommon T echnical D ocument ( eCTD ). eCTD composed of two types of specification Content specification – As defined by ICH Technical specification – Electronic software's PowerPoint Presentation: eCTD is highly recommended by USFDA for NDAs, BLAs, DMFs and INDs filing From year 2010 European Union also make compulsory for electronic CTD submission to all procedures eCTD Characteristics: eCTD Characteristics Structure All Modules 1 to 5 have granularity options. PDF documents linked via XML backbone Increased document granularity. Transparency of entire submission Ease of navigation and review eCTD Template: eCTD Template M1: M1 M2: M2 M3: M3 M4: M4 M5: M5 Benefits of eCTD: Benefits of eCTD

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