CTD Dossier Preparation. Sr.Manager-Regulatory Affairs
|
|
- Blaze James
- 7 years ago
- Views:
Transcription
1 CTD Dossier Preparation K. Srikantha Reddy Sr.Manager-Regulatory Affairs Medreich Limited
2 CTD Dossier Preparation CTD (Common Technical Document) contains 5 modules Module 1 Module 2 Module 3 Module 4 Module 5
3 DMF Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The information contained in the DMF may be used to support following, Investigational New Drug Application (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Export Application.
4 ANDA: An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug. The ANDA contains data which when submitted to FDA's Center For drug Evaluation and Research (CDER), Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.
5
6 Module 1 (e.g. EU) Module-1: Administrative Information and Prescribing Information Cover Letter 1.1 Comprehensive Table of Content 1.2 Application Form Product Information SPC s, Labelling and Packaging Mock-Up Specimen Consultation with target patient group SPC s already approved in the Member states Braille
7 Module Information about the Experts 1.5 Specific Requirements for different types of applications 1.6 Environmental Risk Assessment 1.7 Information relating to Orphan Market Exclusivity 1.8 Information relating to Pharmacovigilance 1.9 Information relating to Clinical Trials 1.10 Information relating to Pediatrics 1.11 Response to Queries 1.12 Additional Data
8 Module - 2 Module - 2: CTD Summary Table of Content t (Comprehensive) 2.2 Introduction (general introduction to the pharmaceutical, including its pharmacology class, mode of action, and proposed clinical i l use) 2.3 Quality Overall Summary 2.4 Non-clinical Overview 2.5 Clinical Overview 2.6 Non-clinical Written and Tabulated Summaries 2.7 Clinical summary
9 Module Non-clinical Overview General e Aspects Content and Structural Format 2.5 Clinical Overview Product Development of Content Rationale Overview of Biopharmaceutics Overview of Clinical Pharmacology Overview of Efficacy Overview of Safety Benefits and Risks Conclusions Literature References
10 Module Non-clinical Written and Tabulated Summaries Pharmacology Pharmacokinetics Toxicology Clinical summary Biopharmaceutic Studies and Associated Analytical Methods Clinical Pharmacology Studies Clinical Efficacy Clinical i l Safety Literature References Synopses of Individual Studies
11 Module - 3 Module 3: Quality 3.1 Table of Contents 3.2 Body of Data 3.2.S Drug Substance 3.2.S.1 General Information 3.2.S.1.1 Nomenclature 3.2.S.1.2 Structure 32S S.1.3 General Properties
12 Module S.2 Manufacture 3.2.S.2.1 Manufacturer Details 3.2.S.2.2 Description of Manufacturing Process and Process Controls 32S S.2.3 Control of Materials 3.2.S.2.4 Controls of Critical Steps and Intermediates 32S S.2.5 Process Validation and /or Evaluation 3.2.S.2.6 Manufacturing Process Development 3.2.S.3 Characterisation 3.2.S.3.1 Elucidation of structure and other Characteristics 3.2.S Impurities
13 Module S.4 Control of Drug Substance 3.2.S.4.1 Specification of Drug Substance 3.2.S.4.2 Analytical Procedures 3.2.S.4.3 Validation of Analytical Procedures 3.2.S.4.4 Batch Analyses 3.2.S.4.5 Justification of Specification 32S5 3.2.S.5 Reference Standards or Materials 3.2.S.6 Container Closure System 3.2.S.7 Stability 3.2.S.7.1 Stability Summary and Conclusions 3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment 3.2.S.7.3 Stability Data
14 Module P Drug Product 3.2.P.1 Description and Composition of the Drug Product 32P2 3.2.P.2 Pharmaceutical Development 3.2.P.2.1 Components of Drug Product 32P P.2.2 Drug Product 3.2.P.2.3 Manufacturing Process Development 3.2.P.2.4 Container Closure System 3.2.P.2.5 Microbiological Attributes 3.2.P.2.6 Compatibility
15 Module P3 3.2.P.3 Manufacture 3.2.P.3.1 Manufacturer 32P P.3.2 Batch Formula 3.2.P.3.3 Description of Manufacturing Process and Process Controls 3.2.P.3.4 Controls of Critical Steps and Intermediates 32P P.3.5 Process Validation and /or Evaluation
16 Module P4 3.2.P.4 Control of Excipients 3.2.P.4.1 Specifications 32P P.4.2 Analytical Procedures 3.2.P.4.3 Validation of Analytical Procedures 3.2.P.4.4 Justification of Specifications 32P P.4.5 Excipients of Human or Animal Origin 3.2.P.4.6 Novel Excipients
17 Module P5 3.2.P.5 Control of Drug Product 3.2.P.5.1 Specification of Drug Product 32P P.5.2 Analytical Procedures 3.2.P.5.3 Validation of Analytical Procedures 3.2.P.5.4 Batch Analyses 3.2.P.5.5 Characterisation of Impurities 3.2.P.5.6 Justification of Specification 3.2.P.6 Reference Standards or Materials 3.2.P.7 Container Closure System
18 Module P.8 Stability 3.2.P.8.1 Stability Summary and Conclusions 3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment 32P P.8.3 Stability Data
19 Module A Appendices 3.2.A.1 Facilities and Equipment 3.2.A.2 Adventitious Agents Safety Evaluation 32A3 3.2.A.3 Novel Excipients 3.2.R Regional Information/ Requirements 3.2.R.1 Process Validation and or Evaluation 3.2.R.2 Medical Device 3.2.R.3 Restricted part of DMF 32R4 3.2.R.4 Medicinal i products containing i or using in the manufacturing process materials of animal and / or human origin. 3.3 List of Literature References
20 Module - 4 Module - 4: Non-clinical Study Reports 4.1 Table of contents 4.2 Study Reports Pharmacology Primary Pharmacodynamic Secondary Pharmacodynamic Safety pharmacology Pharmacodynamic drug interactions
21 Module Pharmacokinetics Analytical Methods and validation Reports Absorption Distribution Metabolism Excretion Pharmacokinetic Drug Interactions Other Pharmacokinetic studies
22 Module Toxicology Single-dose toxicity Repeat-dose toxicity Genotoxicity Carcinogenicity Reproductive and developmental toxicity it Local tolerance Other toxicity studies 4.3 Literature References
23 Module - 5 Module - 5: Clinical i l Study Reports 5.1 Table of Contents 5.2 Tabular Listings of All Clinical Studies 5.3 Clinical Study Reports Bioavailability (BA) study Reports Comparative BA and Bioequivalence study reports In-vitro In-vivo Correlation study reports Reports of Bioanalytical and Analytical methods Plasma Protein Binding Study Reports Reports of Hepatic metabolism and Drug Interaction Studies Reports of Studies Using human Biomaterials
24 Module Healthy Subject PK and Initial Tolerability study reports Patient PK and Initial Tolerability study reports Intrinsic Factor PK study reports Extrinsic i Factor PK study reports Population PK study reports Healthy subject PD and PK/PD study reports Patient PD and PK/PD study reports Study reports of controlled clinical studies
25 Module Study reports of Uncontrolled clinical studies Reports of Analyses of data from more than one study Other clinical study reports Reports of Post-Marketing Experience Case report forms and Individual patient listings 5.4 List of Key Literature References
26 ectd (Version 3.2.2) K. Srikantha Reddy Sr. Manager-Regulatory Affairs Medreich Limited
27 ectd ectd electronic Common Technical Document The ectd is the electronic equivalent to the CTD. Regulatory Perspective The ectd is defined as an interface for industry to agency transfer of regulatory information while at the same time taking into consideration the facilitation of the creation, review, lifecycle management and archival of the electronic submission. Common structure for Modules 2 through 5 Agency specific requirements for Modules 1
28 Technical Perspective ectd Structured set of common folders structure containing PDFs and SAS files (Statistical Analysis Software) on a CD/DVD (Can also be submitted through Agency web portals) The ectd backbone is an XML file (Extensible Markup Language) representing the structure t of the submission, it includes links to files and other metadata such as check sum information. The schema for the XML is very rigid. PDF hyperlinks
29 ectd Granularity of files submitted is small (there are no longer issues of creating large volumes of PDFs). Increased potential for reusing the same submission content across agency submissions. The standard, and many of the modules have been agreed upon by the main worldwide agencies. Once a submission is sent in ectd format all future submissions for the application should be in ectd format. Opportunity to use Part 11 Compliant Electronic Signatures. Use only file formats specified in the guidance
30 ectd Benefits Easy to distribute and review More efficient use of resources, less cost and stress to the organization Highly organized electronic table of contents Searchable Self-validating Integrated document and life-cycle management Cross submission integration Living document New, replace, append & delete
31 How it is different to Paper/Document CTD Overall Table of contents provided in XML (Extensible Markup Language) Utility files to enable technical conformance and viewing i Submission Folders, XML and Utility Files are created automatically ti if an ectd builder is used. Generally high level of granularity in documents Structure is more precise Lifecycle Management of the submission is easier.
32 ectd Implementation - FDA Jan 1, 2008, ectd became CDER s standard for electronic submission. FDA has made it mandatory for all ELECTRONIC submissions i to be in ectd format since However, paper copies are still accepted. Suitable waivers will have to be taken before hand. The number of ANDA submissions to FDA has increased from 72 in the year 2006 to 1550 in 2009
33 ectd Implementation - EU ( p Requirements on Electronic submissions (Nees (Non-eCTD electronic submission, Version 2.0 March-2010) and ectd) and paper documentation for New Application within MRP, DCP or National procedure Refer CMDh/085/2008/Rev7 October 2010) F 1 t J l 2010 th EU M1 1 4 t b d f ll From 1st July 2010, the EU M1 v1.4 must be used for all ectd submissions for all European procedures,
34 ectd Implementation - MHRA h ti t /M k ti th i ations/index.htm The preferred format for new marketing authorization (MA) applications i is the electronic Common Technical Dossier (ectd) ectd applications must be created according to the current specifications: ectd specification v MHRA will accept applications in PDF-only format (Note that all PDF files included in an ectd (irrespective of the module) should be v1.4, except where there is an agency-specific requirement for a later version (e.g. for an application form)). The Summary of Product Characteristics (SmPC) will need to be prepared using the Word template. Use the MHRA Adobe Application form which is available via the MHRA Portal. This will produce an XML file that MHRA can upload directly into their database.
35 Regulatory Contact information
36 ectd Modules When making an electronic submission, each document should be provided as a separate file. The documents, whether for a marketing application, an investigational application, or a related submission, should be organized based on the five modules in the CTD: Module dl 1i includes ld administrative ii i information if i and prescribing information, Module 2 includes CTD summary documents, Module 3 includes information on quality, Module 4 includes the nonclinical study reports, and Module 5 includes the clinical study reports.
37 ectd Template
38 ectd Screen Shot
39 ectd Screen Shot of Module 2
40 ectd Screen Shot of Module 3
41 ectd Screen Shot of Module 4
42 ectd Screen Shot of Module 5
43 ectd Screen Shot of Module 5
44 ectd Screen Shot of Module 5
45 ectd Management Software ectdxpress Image Solutions imagesolutions.com MasterControl Submissions Gateway - Master Control, com Liquent s EZsubs software solution, Data Farm, Take solution : Lorenz Life Sciences :
46 Thank You SRIKANTH.K
Volume 2B Notice to Applicants. Medicinal products for human use. Presentation and format of the dossier. Common Technical Document (CTD)
Volume 2B Notice to Applicants Medicinal products for human use Presentation and format of the dossier Common Technical Document (CTD) Introduction Edition June 26 Module 1 Edition May 28 Module 2 Edition
More informationANDA CHECKLIST FOR CTD or ectd FORMAT FOR COMPLETENESS and ACCEPTABILITY of an APPLICATION FOR FILING
ANDA CHECKLIST FOR CTD or ectd FORMAT FOR COMPLETENESS and ACCEPTABILITY of an APPLICATION FOR FILING For More Information on Submission of an ANDA in Electronic Common Technical Document (ectd) Format
More informationectd Digital Handbook Table of Contents
ectd Digital Handbook Table of Contents Introduction by Emily Ethridge, Editor, FDAnews Part 1 Tutorial Section 1.0 ectd Tutorial Table of Contents. This FDA tutorial, consisting of seven PowerPoint presentations,
More informationICH ectd Specification V 3.2.2 INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
ICH ectd Specification V 3.2.2 16-July-2008 INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH M2 EWG Electronic Common Technical
More informationImporting pharmaceutical products to China
Importing pharmaceutical products to China Imported pharmaceutical products need pre-market approval before entering the Chinese market Imported drugs for human use are required to obtain pre-market approval
More informationM4E(R2): The CTD Efficacy
M4E(R2): The CTD Efficacy This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for
More informationINTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION
More informationGuideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products 1
1 2 3 10 March 2015 EMA/HMPC/71049/2007 Rev. 2 Committee on Herbal Medicinal Products (HMPC) 4 5 6 7 Guideline on the use of the CTD format in the preparation of a registration application for traditional
More informationINTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION
More informationINSIDE STORY FOR REVIEW OF DMF AND DOSSIERS BY REGULATORY AUTHORITIES. (Part I: ANDA, NDA & DMF)
INSIDE STORY FOR REVIEW OF DMF AND DOSSIERS BY REGULATORY AUTHORITIES (Part I: ANDA, NDA & DMF) By Rajkumar Gupta, Managing Director Perfect Pharmaceutical Consultant Pvt. Ltd and Director Global Institute
More informationPOLICY AND PROCEDURES OFFICE OF NEW DRUGS. Good Review Practice: Management of Breakthrough Therapy-Designated Drugs and Biologics.
POLICY AND PROCEDURES OFFICE OF NEW DRUGS Good Review Practice: Management of Breakthrough Therapy-Designated Drugs and Biologics Table of Contents PURPOSE...1 BACKGROUND...2 POLICY...3 ROLES AND RESPONSIBILITIES...4
More informationPL 17871/0208 UKPAR TABLE OF CONTENTS
Fultium-D 3 3,200 IU Capsules PL 17871/0208 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 11 Summary of Product Characteristics Page 12 Patient
More informationCATEGORY Advertising. CATEGORY Biopharmaceutics. CATEGORY Biosimilarity
CATEGORY Advertising Guidance Agenda: New & Guidances CDER is Planning to Publish During Calendar Year 2016 (See the Good Guidance Practices (GGPs) regulation on this Web page or 21 CFR 10.115 for details
More informationEUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL. Brussels, ENTR/CT 1. Revision 1
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market : management & legislation for consumer goods Pharmaceuticals : regulatory framework and market authorisations Brussels, ENTR/CT 1 Revision
More informationGuidance for Industry
Guidance for Industry S9 Nonclinical Evaluation for Anticancer Pharmaceuticals U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center
More informationPublic Assessment Report. Decentralised Procedure
Public Assessment Report Decentralised Procedure Olopatadine Zentiva 1 mg/ml eye drops, solution (olopatadine hydrochloride) Procedure No: UK Licence No: PL 17780/0568 Winthrop Pharmaceuticals UK Limited
More information9th DGRA Annual Congress
Bundesinstitut für Arzneimittel und Medizinprodukte 9th DGRA Annual Congress Electronic Regulatory Submission from the Point of View of the National Drug Agencies - Germany Dr. Klaus Menges, BfArM 13.06.2007,
More informationCOMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP)
European Medicines Agency Veterinary Medicines and Inspections London, 15 April 2005 EMEA/CVMP/134/02 Rev 1 CPMP/QWP/227/02 Rev 1 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY
More informationHarmonised Technical Guidance for ectd Submissions in the EU
Guidance for Industry on Providing Regulatory Information in Electronic Format Harmonised Technical Guidance for ectd Submissions in the EU Version 3.0 August 2013 Page 1 of 60 Table of Contents Table
More information4.1 Objectives of Clinical Trial Assessment
L1 4.1 Objectives of Clinical Trial Assessment Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD, Manager, Clinical Group I Office of Clinical
More informationUnedited version adopted by the 45th WHO Expert Committee on specifications for pharmaceutical preparations. World Health Organization 2010
GUIDELINE ON SUBMISSION OF DOCUMENTATION FOR A MULTISOURCE (GENERIC) FINISHED PHARMACEUTICAL PRODUCT (FPP): PREPARATION OF PRODUCT DOSSIERS (PDS) IN COMMON TECHNICAL DOCUMENT (CTD) FORMAT Unedited version
More informationBiological importance of metabolites. Safety and efficacy aspects
Biological importance of metabolites Safety and efficacy aspects Bernard Walther Technologie Servier Biological importance of metabolites Safety testing of drug metabolites Bioanalytical strategy Structural
More informationBIOTECHNOLOGY OPERATIONS
BIOTECHNOLOGY OPERATIONS Principles and Practices Michael J. Roy TECHNISCHE INFORMATION SBIBLIOTHEK UNIVERSITATSBIBLIOTHEK HANNOVER CRC Press TaylorStFrancis Croup Boca Raton London New York CRC Press
More informationesubmission Guidelines
esubmission Guidelines New ways of working at FAMHP Version 2.11 Publication date: 2/12/2011 Implementation date: 2/12/2011 DOCUMENT HISTORY Date Author Version Comments 14/05/07 André Lhoir 2.6 Updated
More information100 HOT TOPICS FOR DISSERTATION FOR PG DIPLOMA/ DEGREE IN REGULATORY AFFAIRS
100 HOT TOPICS FOR DISSERTATION FOR PG DIPLOMA/ DEGREE IN REGULATORY AFFAIRS Mr. R.M. Gupta (M. Pharm.), is a free lancer consultant for US DMF, COS, ANDA, ACTD, CTD, ectd and he is also the director of
More informationPreparation of a Meaningful and Appropriate Risk Management Plan a Multifunctional Task. Wissenschaftliche Prüfungsarbeit. zur Erlangung des Titels
Preparation of a Meaningful and Appropriate Risk Management Plan a Multifunctional Task Wissenschaftliche Prüfungsarbeit zur Erlangung des Titels Master of Drug Regulatory Affairs der Mathematisch-Naturwissenschaftlichen
More informationFebruary 2006 Procedural
Guidance for Industry Reports on the Status of Postmarketing Study Commitments Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 U.S. Department of Health and
More informationHOMEOPATHIC MEDICINAL PRODUCT WORKING GROUP (HMPWG) GUIDANCE ON MODULE 3 OF THE HOMEOPATHIC MEDICINAL PRODUCTS DOSSIER
HOMEOPATHIC MEDICINAL PRODUCT WORKING GROUP (HMPWG) GUIDANCE ON MODULE 3 OF THE HOMEOPATHIC MEDICINAL PRODUCTS DOSSIER DISCUSSION IN THE HMPWG 2003-2005 RELEASE FOR CONSULTATION December 2005 DEADLINE
More informationDRAFT GUIDANCE ON APPROVAL OF CLINICAL TRIALS & NEW DRUGS
DRAFT GUIDANCE ON APPROVAL OF CLINICAL TRIALS & NEW DRUGS DRAFT GUIDANCE This guidance document is for feedback purposes only. Comments suggestions, if any, may please be submitted to the office of Drugs
More informationRevised checklist for BA/BE NOC effective from 01 st February 2014 (Draft for comments before 25 Jan 14)
Revised checklist for BA/BE NOC effective from 01 st February 2014 (Draft for comments before 25 Jan 14) Documents to be submitted for grant of permission to conduct BA/BE studies in Human Subjects/Patients
More informationGuidance for Industry
Guidance for Industry Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products Center for
More informationGuidance for Industry
Guidance for Industry Food-Effect Bioavailability and Fed Bioequivalence Studies U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)
More informationEUROPEAN INDUSTRIAL PHARMACISTS GROUP
EUROPEAN INDUSTRIAL PHARMACISTS GROUP Guide to Good Regulatory Practice Acknowledgments: Valérie LACAMOIRE, Conseil Central de la section B de l Ordre des Pharmaciens Kelsey MOWER, Industrial Pharmacists
More informationGUIDELINE ON ACTIVE PHARMACEUTICAL INGREDIENT MASTER FILE (APIMF) PROCEDURE 1 (The APIMF procedure guideline does not apply to biological APIs.
15 January 2007 GUIDELINE ON ACTIVE PHARMACEUTICAL INGREDIENT MASTER FILE (APIMF) PROCEDURE 1 (The APIMF procedure guideline does not apply to biological APIs.) TABLE OF CONTENTS 1 INTRODUCTION... 2 2
More informationLacidipine 2 mg Film-Coated Tablets PL 08553/0502. Lacidipine 4 mg Film-Coated Tablets PL 08553/0503. UK Public Assessment Report
Lacidipine 2 mg Film-Coated Tablets PL 08553/0502 Lacidipine 4 mg Film-Coated Tablets PL 08553/0503 UK Public Assessment Report TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken
More informationPublic Assessment Report. Decentralised Procedure
Public Assessment Report Decentralised Procedure TELMISARTAN DR REDDY S 20 MG TABLETS TELMISARTAN DR REDDY S 40 MG TABLETS TELMISARTAN DR REDDY S 80 MG TABLETS (telmisartan) Procedure No: UK/H/5034/001-003/DC
More informationGuidance for Industry
Guidance for Industry Codevelopment of Two or More New Investigational Drugs for Use in Combination U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation
More informationGoals & Objectives. Drug Development & the FDA Pharmacy 309. Outline. An History of Disasters. Be able to describe
Drug Development & the FDA Pharmacy 309 Tom Hazlet, Pharm.D., Dr.P.H. 616-2732 thazlet@u... Goals & Objectives Be able to describe the major regulatory events in the drug development process the concepts
More informationPublic Assessment Report. Scientific discussion. Paracetamol Orifarm 500 mg film-coated tablets. (Paracetamol) DK/H/2271/001/DC.
Public Assessment Report Scientific discussion Paracetamol Orifarm 500 mg film-coated tablets (Paracetamol) DK/H/2271/001/DC 15 October 2014 This module reflects the scientific discussion for the approval
More informationNONCLINICAL EVALUATION FOR ANTICANCER PHARMACEUTICALS
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE NONCLINICAL EVALUATION FOR ANTICANCER PHARMACEUTICALS
More informationGuidance for Industry
Guidance for Industry Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs General Considerations DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments
More informationAgencia Española de Medicamentos y Productos Sanitarios C/Campezo 1, Edificio 8 28022 Madrid España (Reference Member State)
DEPARTAMENTO DE MEDICAMENTOS VETERINARIOS Medicamentos y Productos C/Campezo 1, Edificio 8 28022 Madrid España (Reference Member State) DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR
More informationCOMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) NOTE FOR GUIDANCE ON THE PRE-CLINICAL EVALUATION OF ANTICANCER MEDICINAL PRODUCTS
The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit London, 23 July 1998 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) NOTE FOR GUIDANCE ON THE PRE-CLINICAL
More informationHybrid or Mixed Marketing Authorization Application in the European Union: Not a Trivial Decision in New Development Programs for Established Drugs
Hybrid or Mixed Marketing Authorization Application in the European Union: Not a Trivial Decision in New Development Programs for Established Drugs Drug Information Journal 00(0) 1-6 ª The Author(s) 2012
More informationPublic Assessment Report
Public Assessment Report Decentralised Procedure Zoledronic Acid 4mg/5ml Concentrate for Solution for Infusion Procedure No: UK Licence No: PL 24598/0029 Noridem Enterprises Limited LAY SUMMARY On 25 January
More informationGuideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
1 2 3 03 June May 2013 EMEA/CHMP/BMWP/42832/2005 Rev. 1 Committee for Medicinal Products for Human Use (CHMP) 4 5 6 7 Guideline on similar biological medicinal products containing biotechnology-derived
More informationGuidance for Industry
Guidance for Industry Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications Comments and suggestions regarding this document should be submitted within 90 days of publication in the
More informationOverview of Drug Development: the Regulatory Process
Overview of Drug Development: the Regulatory Process Roger D. Nolan, PhD Director, Project Operations Calvert Research Institute November, 2006 Adapted from course taught by Cato Research Background: Roger
More informationGuidance for Industry
Guidance for Industry Providing Regulatory Submissions in Electronic Format Content of Labeling U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and
More informationGuidance for Industry Safety Testing of Drug Metabolites
Guidance for Industry Safety Testing of Drug Metabolites U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) February 2008 Pharmacology
More informationRegulatory Expectations for GMP: What s Happening. Patricia Weideman, PhD Director, Product Quality & Occupational Toxicology Genentech, Inc.
Regulatory Expectations for GMP: What s Happening Patricia Weideman, PhD Director, Product Quality & Occupational Toxicology Genentech, Inc. Topics Background for changes and expectations of regulatory
More informationGuidance for Industry ANDAs: Stability Testing of Drug Substances and Products
Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products Questions and Answers U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation
More informationGENERAL CONSIDERATIONS FOR CLINICAL TRIALS E8
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE GENERAL CONSIDERATIONS FOR CLINICAL TRIALS E8 Current
More informationPUBLIC ASSESSMENT REPORT Scientific Discussion. Perindopril arginine Amlodipine FR/H/325-326-327/01-04/DC. Applicant: Servier
Direction de l Evaluation des Médicaments et des Produits Biologiques PUBLIC ASSESSMENT REPORT Scientific Discussion COVERAM PERINDOPRIL ARGININE - AMLODIPINE SERVIER PERINDOPRIL ARGININE AMLODIPINE BIOPHARMA
More informationA FDA Perspective on Nanomedicine Current Initiatives in the US
A FDA Perspective on Nanomedicine Current Initiatives in the US Carlos Peña, PhD Office of the Commissioner FDA September 3, 2010 Outline Context Nanotechnology Task Force report summary Identification
More informationQuestions and answers on post approval change management protocols
30 March 2012 EMA/CHMP/CVMP/QWP/586330/2010 Committee for Medicinal Products for Human Use (CHMP) Questions and answers on post approval change management protocols Draft agreed by CHMP / CVMP Quality
More informationExpectations for Data to Support Clinical Trial Drugs
Expectations for Data to Support Clinical Trial Drugs Presentation to: APEC Advanced Workshop on Review of Drug Development in Clinical Trials Bangkok Thailand Feb 2-6 2009 Willem Stevens Ph.D., Chief
More informationChanges to an Approved Product
Changes to an Approved Product Chemistry, Manufacturing and Controls By Khandan Baradaran, PhD and Peggy Berry, MBA, RAC It is a huge achievement for any company to obtain licensing rights to an approved
More informationOur name ASPHALION derives from the Greek word asphaléia, alluding to values such as firmness, stability, certainty and reliability.
Company Profile Our History ASPHALION is an International Drug Development and Regulatory Affairs consultancy firm founded in 2000, with an international team of over 40 people. Our Values Our name ASPHALION
More informationBundesinstitut für Arzneimittel und Medizinprodukte Step-by-step Guide on e-only Submission at BfArM
Step-by-step Guide on e-only Submission at BfArM Version 2.1 Date: December 30, 2014 Conditions for e-only submissions Electronic format only in ectd or NeeS regardless of whether submission concerns a
More informationOverview. Health Science Authority. Implementation of ICH guideline in Singapore. Singapore s experience
ICH and Singapore Dr Christina Lim Deputy Group Director, Health Product Regulation Group Senior Advisor, International Collaboration Health Sciences Authority Singapore November 2008 Overview Health Science
More informationMedicine Safety Glossary
The following definitions are provided as a resource to supplement the information provided in the Medicine Safety Education section of the Pfizer.com Web site; they are not intended as a comprehensive
More informationFood, Medicine and Health Care Administration and Control Authority
Food, Medicine and Health Care Administration and Control Authority Bio equivalence Study Registration Requirements in Ethiopia (Four Countries Experience) Mengistab W.Aregay (Bpharm, MSc. in Health Monitoring
More informationNDA 021879 NDA APPROVAL
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 021879 NDA APPROVAL Avanir Pharmaceuticals Attention: Randall Kaye, M.D. Vice President, Clinical and Medical
More informationLetter Date March 27, 2007 Stamp Date March 28, 2007 PDUFA Goal Date January 28, 2008
CLINICAL REVIEW Application Type NDA Submission Number 22-157 Submission Code Letter Date March 27, 2007 Stamp Date March 28, 2007 PDUFA Goal Date January 28, 2008 Reviewer Name Review Completion Date
More informationPublic Assessment Report. Decentralised Procedure. Sildenafil Dr. Reddy s 25, 50 and 100mg Filmcoated. Sildenafil citrate UK/H/4855/001-3/DC
Public Assessment Report Decentralised Procedure Sildenafil Dr. Reddy s 25, 50 and 100mg Filmcoated Sildenafil citrate UK licence no: PL 08553/0468-70 DR Reddy s Laboratories (UK) Limited 1 LAY SUMMARY
More informationGuidance for Industry and Review Staff Target Product Profile A Strategic Development Process Tool
Guidance for Industry and Review Staff Product Profile A Strategic Development Process Tool DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions
More informationHow To Ensure Biosimilarity
18 December 2014 EMEA/CHMP/BMWP/42832/2005 Rev1 Committee for Medicinal Products for Human Use (CHMP) Guideline on similar biological medicinal products containing biotechnology-derived proteins as active
More informationQuestions and answers on post approval change management protocols
27 October 2010 EMA/CHMP/CVMP/QWP/586330/2010 Questions and answers on post approval change management protocols Draft Draft Agreed by QWP September 2010 Adoption by CHMP for release for consultation 23
More informationHYDROCORTISONE 10 MG TABLETS
HYDROCORTISONE 10 MG TABLETS (Hydrocortisone) PL 20072/0238 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 12 Steps taken after authorisation summary
More informationSession 6 Clinical Trial Assessment Phase I Clinical Trial
L1 Session 6 Clinical Trial Assessment Phase I Clinical Trial Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD, Manager, Clinical Group I Office
More informationRegulatory approval routes in the European System for Medicinal Products
Regulatory approval routes in the European System for Medicinal Products Cardiovascular Combination Pharmacotherapy Global Summit, Melbourne, 8 th May 2014 Presented by: Kevin Blake Human Medicines Research
More informationFrom Drug Discovery to First in Humans
0 :: 2 v01 x y p.345 B xxx.:: B A x y pval«««[xy] -løøøø xxx.:: øøøø -0.02-0.01-0.00 0.00 0.01 0.02.1.2 A PharmaTrain Centre of Excellence Non-Clinical Testing, Pharmaceutical & Early Clinical Development:
More informationOverview of Phase 1 Oncology Trials of Biologic Therapeutics
Overview of Phase 1 Oncology Trials of Biologic Therapeutics Susan Jerian, MD ONCORD, Inc. February 28, 2008 February 28, 2008 Phase 1 1 Assumptions and Ground Rules The goal is regulatory approval of
More informationPublic Assessment Report Scientific discussion. Tenofovir disoproxil Teva (tenofovir disoproxil) SE/H/1432/01/DC
Public Assessment Report Scientific discussion Tenofovir disoproxil Teva (tenofovir disoproxil) SE/H/1432/01/DC This module reflects the scientific discussion for the approval of Tenofovir disoproxil Teva.
More informationGuidance for Industry and FDA Staff FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND Frequently Asked Questions
Guidance for Industry and FDA Staff FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND Frequently Asked Questions U.S. Department of Health and Human Services Food and Drug Administration
More informationRoles & Responsibilities of the Sponsor
Roles & Responsibilities of the Sponsor Developed by Center for Cancer Research, National Cancer Institute, NIH Endorsed by the CTN SIG Leadership Group Objectives Funding for clinical research comes from
More informationPRODUCT DEVELOPMENT GUIDE
PRODUCT DEVELOPMENT GUIDE PRE-FORMULATION - TABLETS Introduction Guidelines for the development of a ANDA product for the US market, Note: some tests or procedures may be unnecessary. The order of performing
More informationICH Topic E 8 General Considerations for Clinical Trials. Step 5 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS (CPMP/ICH/291/95)
European Medicines Agency March 1998 CPMP/ICH/291/95 ICH Topic E 8 General Considerations for Clinical Trials Step 5 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS (CPMP/ICH/291/95) TRANSMISSION
More informationDonepezil hydrochloride 10 mg film-coated tablets PL 19156/0130
Donepezil hydrochloride 10 mg film-coated tablets PL 19156/0130 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 4 Steps Taken for Assessment Page 12 Summary of Product Characteristics
More informationGuidance for Industry
Guidance for Industry Q2B Validation of Analytical Procedures: Methodology November 1996 ICH Guidance for Industry Q2B Validation of Analytical Procedures: Methodology Additional copies are available from:
More informationRisk Management in the Pharmaceutical Industry. Elena Apetri, Global Medical Safety Surveillance Schering AG
Risk Management in the Pharmaceutical Industry Elena Apetri, Global Medical Safety Surveillance Schering AG Topics Environment Safety Risk Management Guidance Safety RM Systems Signal detection and evaluation
More informationA clinical research organization
A clinical research organization About Us State of art facility. All clinical trials carried out in accordance with ICH GCP guidelines. Quality services within stipulated time period. Team of experienced
More informationTGN 1412 Welche Änderungen haben sich für die Erstanwendung am Menschen aus Sicht des BfArM ergeben?
TGN 1412 Welche Änderungen haben sich für die Erstanwendung am Menschen aus Sicht des BfArM ergeben? PD Dr. med. Thomas Sudhop Bundesinstitut für Arzneimittel, Bonn Bundesinstitut für Arzneimittel IMP
More informationIMPURITIES IN NEW DRUG PRODUCTS
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE IMPURITIES IN NEW DRUG PRODUCTS Q3B(R2) Current
More informationACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE (APIC) ectd HOW TO DO DOCUMENT. July 2014
ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE (APIC) ectd HOW TO DO DOCUMENT July 2014 Table of Content 1. CHAPTER 1: REGULATORY FRAMEWORK & NATIONAL REQUIREMENTS... 5 1.1 Introduction: view of authorities
More informationProviding Regulatory Submissions In Electronic Format Standardized Study Data
Providing Regulatory Submissions In Electronic Format Standardized Study Data Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation
More informationTRAMADOL HYDROCHLORIDE AND PARACETAMOL 37.5 MG/325 MG FILM-COATED TABLETS (tramadol hydrochloride and paracetamol ) PL 30684/0222 UKPAR
TRAMADOL HYDROCHLORIDE AND PARACETAMOL 37.5 MG/325 MG FILM-COATED TABLETS (tramadol hydrochloride and paracetamol ) PL 30684/0222 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4
More informationPublic Assessment Report. Decentralised Procedure
Public Assessment Report Decentralised Procedure Levetiracetam 250 mg film-coated tablets PL 36390/0168; UK/H/5630/001/DC Levetiracetam 500 mg film-coated tablets PL 36390/0169; UK/H/5630/002/DC Levetiracetam
More informationPublic Assessment Report. UK National Procedure. (colecalciferol) PL 16508/0047 PL 16508/0048. ProStrakan Ltd.
Public Assessment Report UK National Procedure STEXEROL-D 3 1,000 IU FILM-COATED TABLETS STEXEROL-D 3 25,000 IU FILM-COATED TABLETS (colecalciferol) PL 16508/0047 PL 16508/0048 ProStrakan Ltd. 1 LAY SUMMARY
More informationManufacturing process of biologics
Manufacturing process of biologics K. Ho Afssaps, France 2011 ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 2011 ICH 1 Disclaimer:
More informationGDUFA (GENERIC DRUG USER FEE ACT): Q&A TELECONFERENCE 26 TH JUNE 2012
The US-FDA pending Generic Drug User Fees Act (GDUFA) is expected to come into force on 1 st October, 2012. A slide set was provided to participants as a comprehensive brief to stimulate questions. Those
More informationCTC Technology Readiness Levels
CTC Technology Readiness Levels Readiness: Software Development (Adapted from CECOM s Software Technology Readiness Levels) Level 1: Basic principles observed and reported. Lowest level of software readiness.
More informationICH Topic Q 5 E Comparability of Biotechnological/Biological Products
European Medicines Agency June 2005 CPMP/ICH/5721/03 ICH Topic Q 5 E Comparability of Biotechnological/Biological Products Step 5 NOTE FOR GUIDANCE ON BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS SUBJECT TO CHANGES
More informationGuidance for Industry
Guidance for Industry Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.
More informationPublic Assessment Report. UK National Procedure. Perindopril 2 mg Tablets. Perindopril 4 mg Tablets. Perindopril 8 mg Tablets PL 20075/0294-0296
Public Assessment Report UK National Procedure Perindopril 2 mg Tablets Perindopril 4 mg Tablets Perindopril 8 mg Tablets PL 20075/0294-0296 Accord Healthcare Limited 1 LAY SUMMARY This is a summary of
More informationLiposome Drug Products
Liposome Drug Products Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation Guidance for Industry DRAFT GUIDANCE This guidance document is being
More informationTHE CHANGING FACE OF HEALTH CARE INFORMATION MANAGEMENT
THE CHANGING FACE OF HEALTH CARE INFORMATION MANAGEMENT Graham Shelvey Director Regulatory Operations EU&Int. sanofi aventis Erick Gaussens Chief Scientific Officer ProductLife Group A reality : Information
More informationGuidance for Industry
Guidance for Industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals U.S. Department of Health and Human Services Food and Drug
More informationPharmaPendium. The definitive source of best-in-class drug information
Please contact us for more information Americas E-Customer Service 360 Park Avenue South New York, NY 10010-1710 USA Tel: +1 888 615 4500 (+1 212 462 1978, if calling from outside the USA and Canada) Fax:
More information