Wirkstoffdokumentation & CEP- Verfahren
|
|
- Kathryn Bishop
- 6 years ago
- Views:
Transcription
1 Wirkstoffdokumentation & CEP- Verfahren Dr. Wolfgang Herzog AGES PharmMed, Institut Zulassung & Lifecycle Management AGES-Gespräch Am Pulsschlag des Arzneimittelwesens Das Institut LCM Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
2 Documentation of Drug Substance Guideline of requirements for active substances in the quality part of the dossier (CHMP/QWP/297/97 Rev. 1): -Classification of active substances - Feasible ways to submit the required information 2
3 Documentation of Drug Substance New active substances Existing active substances not described in Ph. Eur./pharmacopoeia of EU member state Existing active substances described in Ph. Eur./ pharmacopoeia of EU member state 3
4 Documentation of Drug Substance Inorganic substances Herbal drugs and herbal drug preparations Organic substances (isolated from material of animal/human origin) Organic substances (synthetic or semi-synthetic or isolated from herbal sources or microorganism) 4
5 Documentation of Drug Substance Certificate of Suitability (CoS/CEP) Active Substance Master File (ASMF): Full Documentation as part of the MA application 5
6 Documentation of Drug Substance Chemistry of Active Substances (3AQ5A) Chemistry of New Active Substances (CPMP/QWP/130/96 Rev. 1) 6
7 Documentation of Drug Substance 3.2.S Drug Substance 3.2.S.1 General Information 3.2.S.2 Manufacture 3.2.S.3 Characterisation 3.2.S.4 Control of Drug Substance 3.2.S.5 Reference Standards or Materials 3.2.S.6 Container Closure System 3.2.S.7 Stability 7
8 Active Substance Master File (ASMF): - Nfg on ACTIVE SUBSTANCE MASTER FILE CPMP/QWP/227/02 Rev. 1 Date for coming into operation: "Applicants Part " (AP) and "Restricted Part " (RP) - Structure of the ASMF o human: in CTD format (since 1 st January 2005) o veterinary: according to NtA veterinary format or CTD 8
9 Active Substance Master File (ASMF): Scope: - New active substances - Existing active substances not included in the Ph. Eur. or pharmacopoeia of an EU Member State - Pharmacopoeial active substances Not in the Scope: Biological Substances!!!!! 9
10 Active Substance Master File (ASMF): The EDMF holder should submit to the Applicant: - A copy of the latest version of the AP - A copy of the QOS/ER on the latest version of the AP - Letter of access where this letter has not been sumitted earlier for the product concerned 10
11 Active Substance Master File (ASMF): The EDMF holder should submit to the Competent Authorities: - The EDMF accompanied by a covering letter - Letter of access where this letter has not been sumitted earlier for the product concerned 11
12 Common Technical Document (CTD): 3.2.S Drug Substance S.1 General Information o 3.2.S.1.1 Nomenclature rinn, compendial (Ph. Eur.) name, national approved names (Company or laboratory code) Reference CPMP Guideline: Chemistry of the Active Substance o 3.2.S.1.2 Structure Structural formula, rel. molecular mass o 3.2.S.1.3 General Properties Physicochemical properties (solubility, isomerism, ) 12
13 Common Technical Document (CTD): 3.2.S Drug Substance S.2 Manufacture o 3.2.S.2.1 Manufacturer(s) Name, Address o 3.2.S.2.2 Description of the Manufacturing Process Flow diagram Sequential procedural narrative Alternative processes, reprocessing Operating conditions Yield 13
14 Common Technical Document (CTD): 3.2.S Drug Substance S.2 Manufacture o 3.2.S.2.3 Control of Materials Starting material, solvents, reagents, catalysts, etc. Specifications should be submitted o 3.2.S.2.4 Control of critical steps and intermediates Tests und Acceptance criteria 14
15 Common Technical Document (CTD): 3.2.S Drug Substance S.2 Manufacture o 3.2.S.2.5 Process validation and/or Evaluation aseptic processing sterilisation o 3.2.S.2.6 Manufacturing Process Development Description of any significant changes 15
16 Common Technical Document (CTD): 3.2.S Drug Substance S.3 Characterisation o 3.2.S.3.1 Elucidation of Structure and other Characteristica Unequivocal proof of structure (Elemental analysis, UV/VIS Maxima, IR, 1 H/ 13 C NMR, MS, ) Information regarding Isomerism, Polymorphism (melting point, X-Ray powder diffraction, see EP 5.9), etc. 16
17 Common Technical Document (CTD): 3.2.S Drug Substance S.3 Characterisation o 3.2.S.3.2 Impurities Impurity profile: Starting material By-products Degradation products Reagents, ligands and catalysts Residual solvents Inorganic impurities 17
18 Common Technical Document (CTD): 3.2.S Drug Substance S.4 Control of the Active Substance (see EP-Monograph Substances for Pharmaceutical Use 01/2008:2034) o 3.2.S.4.1 Specification o 3.2.S.4.2 Analytical Procedures o 3.2.S.4.3 Validation of Analytical Procedures 18
19 Common Technical Document (CTD): 3.2.S Drug Substance S.4.1 Specification: minimum requirements o o o o o o o Description Identification Assay and/or potency Impurities - identified Impurities - unidentified Impurities -total Impurities 19
20 Common Technical Document (CTD): 3.2.S Drug Substance S.4.1 Specification additional Parameters - (see ICH Q6A- decision trees ) o Physicochemical properties o Particle size o Polymorphic forms (CPMP/ICH/2738/99 does not apply) o Tests for chiral substance (CPMP/ICH/2738/99 does not apply) o Water content o Inorganic impurities o Microbial limits (TAMC/TYMC see EP 5.1.4) 20
21 Common Technical Document (CTD): 3.2.S Drug Substance S.4 Control of the Active Substance o 3.2.S.4.4 Batch Analysis Recent consecutive batches (at least 3 pilot batches) Date of manufacture Batch size and number Place of manufacture Results of analytical determination o 3.2.S.4.5 Justification of Specification 21
22 Common Technical Document (CTD): 3.2.S Drug Substance S.5 Reference standards o Information on the reference standards used for testing of the active substance o Establishing of the reference standards (Primary and Secondary) o Specification 22
23 Common Technical Document (CTD): 3.2.S Drug Substance S.5 Reference standards o A European Pharmacopoeia reference standard is an integral and essential part of the monograph and as such is an official standard that is alone authoritative in case of doubt or disbute (see also chapter 5.12) 23
24 Common Technical Document (CTD): 3.2.S Drug Substance S.6 Container Closure System o Primary packaging material (see CPMP/QWP/4359/03) Details of the materials of construction Chemical name of the material Specification (EP-conformity if applicable) o Secondary packaging material 24
25 Common Technical Document (CTD): 3.2.S Drug Substance S.7 Stability o 3.2.S.7.1 Stability Summary and Conclusion o CPMP/QWP/122/02 Rev. 1 corr o CPMP/ICH/2736/99 (ICH Q1A (R2)) o CPMP/ICH/279/95 (ICH Q1B) 25
26 Common Technical Document (CTD): 3.2.S Drug Substance S.7 Stability o 3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment o 3.2.S.7.3 Stability Data 26
27 Council of Europe 27
28 Certificate of Suitability (CoS/CEP)* Purpose of the procedure Facilitating and simplifying exchanges between the partners to ensure that the quality of substances is guaranteed These substances comply with the European Pharmacopoeia Promotefreemovementof medicines 28
29 Certificate of Suitability (CoS/CEP)* Excluded from the Application: Direct gene products (proteins) Products obtained from human tissues, vaccines and blood products and preparations other biological substances (see list of CMD(h)) 29
30 Application types - Simple certificate (chemical or TSE or herbal product) - Certificate for chemical purity and sterility - Double certificate (chemical and TSE) - Double certificate (chemical and TSE) covering also sterility 30
31 Overview of the procedure - Submission of the dossier - Acknowledgement of receipt - Designation of a rapporteur - Assessment - Notification of the decision - Follow up the Certification of Suitability 31
32 Assessment - Preparation of a report in three parts: - Report A or Confidential report - Report B or Request for revision of the monograph - Report C or Comments for the inspectors 32
33 Certificate of Suitability (CoS/CEP)* Documentation in the MA application: - Copy of the CoS has to be enclosed - Declaration of Access (not mandatory!) - GMP Declaration from the Qualified Person of the Batch Releaser and Manufacturer - Specification of the Applicant (with additional Parameters e.g. physical-chemical characteristics such as particle size) 33
34 Certificate of Suitability (CoS/CEP)* Ländervergleich DE AT ES UK NL BE *CH* FR IT DK FI 4 SE IS CZ HU 6 IE *Canada* 4 4 Gutachter Gutachtertage Quelle: EDQM 34
35 Thank You! Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
Guideline on the chemistry of active substances for veterinary medicinal products
9 November 2017 EMA/CVMP/QWP/707366/2017 Committee for Medicinal Products for Veterinary Use (CVMP) Guideline on the chemistry of active substances for veterinary medicinal products Draft agreed by Quality
More informationContent of the dossier for chemical purity and microbiological quality
Division Certification of Substances CP/CB PUBLIC DOCUMENT (Level 1) English only/anglais seulement PA/PH/ CEP (0) 1 R February 0 Certification of suitability of Monographs of the European Pharmacopoeia
More informationThe procedure of Certification of Suitability to the Monographs of the European Pharmacopoeia (CEP) and the EDQM Inspection Programme
18/10/2016 The procedure of Certification of Suitability to the Monographs of the European Pharmacopoeia (CEP) and the EDQM Inspection Programme Chinese & European Pharmacopoeias Workshop 17 October 2016
More informationCertification of suitability to the Monographs of the European Pharmacopoeia
AMM/CB PUBLIC DOCUMENT (LEVEL 1) English only/anglais seulement Strasbourg, September 2018 Certification of suitability to the Monographs of the European Pharmacopoeia GUIDELINE ON REQUIREMENTS FOR REVISION/RENEWAL
More informationQuality aspects Overview. QP declaration
Quality aspects Overview QP declaration Standards for the quality part of the dossier with focus on: - Materials from animals, nosodes - Proof of microbiological quality, pesticides, heavy metals, organic
More informationReflection paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances
3 July 2017 EMA/CHMP/CVMP/QWP/826771/2016 Corr. 1 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) Reflection paper on the requirements for
More informationCOMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) NOTE FOR GUIDANCE ON SUMMARY OF REQUIREMENTS FOR ACTIVE SUBSTANCES IN PART II OF THE DOSSIER
The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit London, 28 January 1998 CPMP/QWP/297/97 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) NOTE FOR GUIDANCE
More informationASMF/DMF Quality Assessment Report (QAR) IGDRP Quality Working Group
ASMF/DMF Quality Assessment Report (QAR) IGDRP Quality Working Group Version Description of Change Author Effective Date v 1.0 Original publication ASMF/DMF WG May 26, 2015 v 1.1 Watermark added ASMF/DMF
More informationCEP submission: How to prepare a New Application?
CEP submission: How to prepare a New Application? Nathalie Vicente Certification of Substances Division Summary How to prepare a New Application? Requirements for a new CEP application Content of the dossier
More informationEnglish only/anglais seulement PA/PH/CEP (15) 31. Certification of suitability to the Monographs of the European Pharmacopoeia.
MMF/CB PUBLIC DOCUMENT (Level 1) English only/anglais seulement PA/PH/CEP (15) 31 Strasbourg, April 2018 Certification of suitability to the Monographs of the European Pharmacopoeia How to read a CEP Address:
More informationGUIDANCE FOR QUALITY ASSESSORS DRUG SUBSTANCE. IGDRP Quality Working Group
GUIDANCE FOR QUALITY ASSESSORS DRUG SUBSTANCE IGDRP Quality Working Group Version Description of Change Author Effective Date v 1.0 Original publication Quality WG June 8, 2017 Foreword In order to achieve
More informationNew Frontiers in the Quality of Medicines
New Frontiers in the Quality of Medicines Workshop Certification: How to use a Certificate (CEP) Moderators: Dr Jean-Louis Robert Prof Derek H. Calam EDQM International Conference 13-15 June 2007 Strasbourg,
More informationGuideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials
1 2 3 18 February 2010 EMA/CHMP/BWP/534898/2008 Committee for Medicinal Products for Human Use (CHMP) 4 5 6 7 Guideline on the Requirements for Quality Documentation Concerning Biological Investigational
More informationGuideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE- GENERAL Health systems and products Medicinal products quality, safety and efficacy 18 February 2010 EMA/CHMP/BWP/534898/2008 Committee for Medicinal
More informationICH Topic M 4 Q Location issues for Common Technical Document for the Registration of Pharmaceuticals for Human Use Quality Questions and Answers
European Medicines Agency August 2003 CPMP/ICH/4680/02 ICH Topic M 4 Q Location issues for Common Technical Document for the Registration of Pharmaceuticals for Human Use Quality Questions and Answers
More informationEuropean Medicines Agency Inspections
European Medicines Agency Inspections London, 31 March 2006 CHMP/QWP/185401/2004 final COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE REQUIREMENTS TO THE CHEMICAL AND PHARMACEUTICAL
More informationRegulatory expectations on impurities in drug substances - Pavia, October 2, Luisa Torchio Euticals SpA
Regulatory expectations on impurities in drug substances - Pavia, October 2, 2015 Luisa Torchio Euticals SpA An Impurity is defined as any substance or element present in a drug substance (DS) that is
More informationINFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES COMMISSION
EN EN EN INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES COMMISSION Communication from the Commission Guideline on the details of the various categories of variations to the terms of marketing
More informationMaterials Management Traceability, CEPs and managing non-conforming sites
Materials Management Traceability, CEPs and managing non-conforming sites IMB Information Day, 14 th October 2010 Dr Cormac Dalton Inspector 13-Oct-10 Slide 1 Managing Supply Supply Demand Supply chain
More information(Information) INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES EUROPEAN COMMISSION
22.1.2010 Official Journal of the European Union C 17/1 (Information) INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGCIES EUROPEAN COMMISSION Communication from the Commission Guideline
More informationQuality Assessment & GMP Similarities & Differences
Quality Assessment & GMP Similarities & Differences EMEA, Monday 26 th October 2009 Cormac Dalton Inspector Irish Medicines Board Date 12-Oct-09 Slide 1 Content Overview of commonalities & differences
More informationPharmaceutical Standards for Artemisinin and its derivatives Requirements for Prequalification of ACTs
Pharmaceutical Standards for Artemisinin and its derivatives Requirements for Prequalification of ACTs Artemisinin Forum 2008 Guilin, China Maryam MEHMANDOUST, PhD Prequalification of Medicines Programme
More informationPharmacopoeial Reference Standards
Pharmacopoeial Reference Standards Industry view point Antony Raj Gomes Head- Quality Management 1 Presentation Overview Indian Industry an update Available guidelines Industry practices Current challenges
More informationHow to prepare an application for revision of a CEP
How to prepare an application for revision of a CEP P.Poukens-Renwart, PhD Certification of Substances Division EDQM Summary Validity of a CEP Revision background Types of revisions and examples How to
More informationProposals for the Guideline on Classification of Variations. Only those variations applicable to the active substance are listed.
December 2008 Proposals for the Guideline on Classification of Variations Only those variations applicable to the active substance are listed. A variation which is not an extension and whose classification
More informationAPPLICATION FOR VARIATION TO A MARKETING AUTHORISATION
Page 1 of 13 May 2008 APPLICATION FOR VARIATION TO A MARKETING AUTHORISATION HUMAN VETERINARY NATIONAL AUTHORISATION IN MRP MRP variation number 1A : / / / / / COMMUNITY AUTHORISATION EMEA variation number
More informationGuideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials
1 2 3 23 June 2016 EMA/CHMP/BWP/534898/2008 rev. 1 Committee for Medicinal Products for Human Use (CHMP) 4 5 6 7 Guideline on the requirements for quality documentation concerning biological investigational
More informationSPECIFIC MONOGRAPHS. A Guide Through The Different Sections. Claude Coune
SPECIFIC MONOGRAPHS A Guide Through The Different Sections Claude Coune Claude Coune, EDQM, Council of Europe, All rights reserved, 2010 1 Contents of the European Pharmacopoeia: nearly 2100 monographs
More informationOn the Q&A to the Guideline for Common Technical Documents
To: Public Health Bureau Prefectural Government Letter from PFSB/ELD 22 nd October 2001 From: Evaluation & Licensing Division, Pharmaceutical & Food Safety Bureau, The Ministry of Health, Labour and Welfare
More informationGuideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials
14 September 2017 EMA/CHMP/BWP/534898/2008 rev. 1 Committee for Medicinal Products for Human Use (CHMP) Guideline on the requirements for quality documentation concerning biological investigational medicinal
More informationDECISION TREE #1: ESTABLISHING ACCEPTANCE CRITERION FOR A SPECIFIED IMPURITY IN A NEW DRUG SUBSTANCE
DECISION TREE #1: ESTABLISHING ACCEPTANCE CRITERION FOR A SPECIFIED IMPURITY IN A NEW DRUG SUBSTANCE Determine impurity level in relevant batches 1 Determine mean + upper confidence limit for the impurity
More informationGUIDELINE ON DOSSIER REQUIREMENTS FOR TYPE IA AND TYPE IB NOTIFICATIONS July 2003
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market : management & legislation for consumer goods Pharmaceuticals : regulatory framework and market authorisations Final Revision 0 NOTICE TO
More informationEurope s new approach to assurance of API quality and its implications for manufacturers and producing countries
Europe s new approach to assurance of API quality and its implications for manufacturers and producing countries IPA / EDQM / WHO Mumbai Conference 28 September 2012 Dr Florence Benoit-Guyod, EDQM Inspector,
More information5. Changes to a CEP or to a confirmation of API-prequalification document 106
Annex 3 WHO guidelines on variations to a prequalified product Introduction 96 1. Background 97 1.1 Objectives 97 1.2 Scope and application 98 2. Guidance for implementation 99 2.1 s 99 2.1.1 Notifications
More informationCOMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP)
The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use London, 17 December 2003 CPMP/QWP/122/02, rev 1 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) GUIDELINE
More informationPost approval change of Japanese registration dossiers and impact on market supply
Post approval change of Japanese registration dossiers and impact on market supply Table of content Table of content Business model evolution of API sales Challenge on Regulatory compliance Risks of Regulatory
More informationImplementation of ICH Q3D in the Certification Procedure
LS/CB PUBLIC DOCUMENT (LEVEL 1) PA/PH/CEP (16) 23 Strasbourg, August 2016 Certification of suitability to the Monographs of the European Pharmacopoeia Implementation of ICH Q3D in the Certification Procedure
More informationGuidance Document 01 January 2016 CONTENTS. 1. Introduction Background 1.2. Objectives 1.3. Scope and application 1.4 APIMF holder obligations
GUIDANCE ON AMENDMENTS TO AN ACTIVE PHARMACEUTICAL INGREDIENT MASTER FILE (APIMF) SUBMITTED IN SUPPORT OF A PREQUALIFIED PHARMACEUTICAL PRODUCT (FPP) OR PREQUALIFIED ACTIVE PHARMACEUTICAL INGREDIENT (API)
More informationMODULE 2.3 QUALITY OVERALL SUMMARY PRODUCT DOSSIER (QOS PD)
MODULE 2.3 QUALITY OVERALL SUMMARY PRODUCT DOSSIER () INTRODUCTION The introduction should include proprietary name, non-proprietary name or common name of the drug substance, company name, dosage form(s),
More informationEuropean Pharmacopoeia Reference Standards A Lodi, Head of the Laboratory Department, EDQM, Council of Europe
European Pharmacopoeia Reference Standards A Lodi, Head of the Laboratory Department, EDQM, Council of Europe Content Ph. Eur. Reference Standards General notices, terms and definitions Key attributes
More informationICH Q11 Development & manufacture of drug substances
ICH Q11 Development & manufacture of drug substances Keith McDonald Group Manager Medicines & Healthcare products Regulatory Agency (UK) 2011 ICH International Conference on Harmonisation of Technical
More informationPHARMA KNOWLEDGE PARK
GUIDELINES 2013 WWW.NOORMD.COM A COMPILATION BY ON PHARMACEUTICAL REGULATORY GUIDELINES INTRODUCED / REVISED DURING THE YEAR 2013. Page 2 ICH Assessment and control of DNA reactive (mutagenic) impurities
More informationA GUIDELINE ON DOSSIER REQUIREMENTS FOR TYPE I VARIATIONS November 1999
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Pharmaceuticals and cosmetics Final Revision 0 NOTICE TO APPLICANTS A GUIDELINE ON DOSSIER REQUIREMENTS FOR TYPE I VARIATIONS November 1999 This guideline
More informationMedicine Variations Guideline
Medicine Variations Guideline National Health Regulatory Authority (NHRA) Kingdom of Bahrain 30 th March 2017 Version 2.0 Chief of Pharmaceutical Product Regulation: Dr/Roaya Al Abbasi Date: NHRA CEO Approval:
More informationImpurities from degradation of Drug Substances
Impurities from degradation of Drug Substances REFERENCE 1. ICH - IMPURITIES IN NEW DRUG SUBSTANCES - Q3A(R2) 2. ICH - IMPURITIES IN NEW DRUG PRODUCTS - Q3B(R2) 3. ICH - VALIDATION OF ANALYTICAL PROCEDURES:
More informationICH Topic Q 3 A Impurities Testing Guideline: Impurities in New Drug Substances
The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit CPMP/ICH/142/95 ICH Topic Q 3 A Impurities Testing Guideline: Impurities in New Drug Substances Step 5 NOTE
More informationWHO guidelines on variations to a prequalified product
Annex 3 WHO guidelines on variations to a prequalified product Introduction 96 1. Background 97 1.1 Objectives 97 1.2 Scope and application 98 2. Guidance for implementation 99 2.1 s 99 2.1.1 Notifications
More informationA.1 Contents file 4 to 5 A.1 (1)
Contents file 4 to 5 Contents file 4 to 5 A Information Contents file 4 to 5 A.2 Index file 4 to 5 A.3 List of Abbreviations A.4 Glossary A.5 Adress-Register A.6 References B Japanese Regulations B.1 MHW
More informationAdopted by CHMP for release for consultation 15 December Start of public consultation 15 December 2016
1 September 2017 EMA/CHMP/ICH/809509/2016 Committee for Human Medicinal Products ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological / biological
More informationGUIDELINES FOR VARIATION OF REGISTERED MEDICINAL PRODUCTS
GUIDELINES FOR VARIATION OF REGISTERED MEDICINAL PRODUCTS National Drug Authority Head Office Rumee Towers Plot 19, Lumumba Avenue P. O. Box 23096 Kampala, Uganda. Tel: +256-0414 - 255665/347391/2 E-mail:
More informationImplementation strategy of ICH Q3D guideline
1 2 3 1 July 2016 EMA/404489/2016 Committee for Medicinal Products for Human use (CHMP) 4 5 Draft Draft agreed by QWP and BWP June 2016 Adopted by CHMP for release for consultation June 2016 Start of public
More informationPrimary / secondary standards in pharmaceutical QC. Dr. Christian Zeine LGC Standards GmbH. Webinar Series 2013 July 2013
Primary / secondary standards in pharmaceutical QC Dr. Christian Zeine LGC Standards GmbH Webinar Series 2013 July 2013 Quick guide to the webinar tools Slide 2 Topics of today s talk Close look on: Main
More informationJ Pharm Pharmaceut Sci (www.cspscanada.org) 12(2): , 2009
Where is Industry Getting it Wrong? A Review of Quality Concerns Raised at Day 120 by the Committee for Medicinal Products for Human Use during European Centralised Marketing Authorisation Submissions
More informationRevisions of CEPs. Basic principles for maintaining a CEP
Revisions of CEPs Nimet FILIZ Certification of Substances Department, EDQM Basic principles for maintaining a CEP Any change must be reported to EDQM for approval Original CEP is valid 5 years Holder needs
More informationMedicines Variations Guideline
Medicines Variations Guideline National Health Regulatory Authority (NHRA) Kingdom of Bahrain 27/08/2014 Version 1.1 Chief of Pharmaceutical Product Regulation: Dr / Roaya Al Abbasi Date: NHRA CEO Approval:
More informationWorkshop on Skip Testing
12-13 June 2018, Bern, Switzerland Workshop on Skip Testing Rosmarie Neeser Swissmedic, Inspectorates and Licences, Inspector Swissmedic Schweizerisches Heilmittelinstitut Hallerstrasse 7 3000 Bern 9 Schweiz
More informationConsultation by a notified body on an ancillary medicinal substance integrated in a medical device
Consultation by a notified body on an ancillary medicinal substance integrated in a medical device Documentation requirements for an initial consultation Language : French or English Because of the wide
More informationPublic Assessment Report. Scientific discussion. Paricalcitol Accord 2 microgram/ml and 5 microgram/ml solution for injection.
Public Assessment Report Scientific discussion Paricalcitol Accord 2 microgram/ml and 5 microgram/ml solution for injection (paricalcitol) NL/H/3107/001-002/DC Date: 12 October 2015 This module reflects
More informationCMC Considerations for 505(b)(2) Applications. Monica Cooper, Ph.D. FDA/CDER/OPS/ONDQA AAPS Annual Meeting Washington, D.C.
CMC Considerations for 505(b)(2) Applications Monica Cooper, Ph.D. FDA/CDER/OPS/ONDQA AAPS Annual Meeting Washington, D.C. October 2011 1 Introduction Outline Brief overview of FDA drug approval pathways
More informationOverview of comments received on 'Draft Guideline on the chemistry of active substances (veterinary) (EMA/CVMP/QWP/49477/2017)
23 October 2017 EMA/CVMP/QWP/502315/2017 Committee for Medicinal Products for Veterinary Use (CVMP) Overview of comments received on 'Draft Guideline on the chemistry of active substances (veterinary)
More informationEUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL QUESTIONS. and ANSWERS
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, F2/SM D (2008) QUESTIONS and ANSWERS The rules governing medicinal products in the European Union VOLUME 2 NOTICE
More informationICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities)
May 2011 EMA/CHMP/ICH/425213/2011 ICH/ Committee for medicinal products for human use (CHMP) ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological
More informationDocumentation requirements for an initial consultation
Language : French or English Documentation requirements for an initial consultation Because of the wide range of medical devices which incorporate, as an integral part, an ancillary medicinal substance,
More informationANMAT Order No 5260/2008
ANMAT Order No 5260/2008 HAVING REGARD TO Laws Nos 16.463, 17.818, 19.303; Decrees Nos 9763/64, 150/92, 1890/92, 177/93; Joint Resolutions Nos 268/92 (M.S. and A.S.) and 470/92 (M.E. and O.S.P.) and No
More informationGUIDANCE ON VARIATIONS TO A PREQUALIFIED PRODUCT
May 2012 RESTRICTED 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 GUIDANCE ON VARIATIONS TO A PREQUALIFIED PRODUCT DRAFT FOR
More informationGUIDANCE ON VARIATIONS TO A PREQUALIFIED DOSSIER
RESTRICTED GUIDANCE ON VARIATIONS TO A PREQUALIFIED DOSSIER Since being presented to the Fortieth meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2005 this
More informationJournal of Chemical and Pharmaceutical Research
Available online www.jocpr.com Journal of Chemical and Pharmaceutical Research ISSN No: 0975-7384 CODEN(USA): JCPRC5 J. Chem. Pharm. Res., 2011, 3(6):88-98 Conduct of Inspections for Pharmaceutical Manufactures
More informationCurrent Hotspots during CMC Evaluation a European Regulatory Perspective
www.pei.de Current Hotspots during CMC Evaluation a European Regulatory Perspective CMC Strategy Forum Japan 2018 3-4 December, Tokyo Steffen Gross, Head Section monoclonal - and polyclonal Antibodies
More informationStructure and content of an IMPD. What is required for first into man trial?
What is required for first into man? The EU IMPD Thomas Sudhop, MD Scope Structure and content of an IMPD What is required for first into man trial? Only for IMPs that do not have a marketing authorisation
More informationPharmacist Rana Musa Al-ali (Malkawi) MSc (Pharmaceutical Quality Assurance) Registration Department/JFDA
Pharmacist Rana Musa Al-ali (Malkawi) MSc (Pharmaceutical Quality Assurance) Registration Department/JFDA 1 2 ND MENA Regulatory Conference On Bioequivalence, Biowaivers, Bioanalysis, Dissolution & Biosimilars
More informationGUIDELINES ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF HUMAN PHARMACEUTICAL PRODUCTS
Doc. No. TFDA/DMC/MCER/ TANZANIA FOOD AND DRUGS AUTHORITY GUIDELINES ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF HUMAN PHARMACEUTICAL PRODUCTS (Made under Section 52 (1) of the Tanzania Food, Drugs
More informationGuideline on setting specifications for related impurities in antibiotics
1 2 3 4 14 July 2010 EMA/CHMP/CVMP/QWP/199250/2009 Committee for Medicinal Products for Human Use (CHMP) / Committee for Medicinal Products for Veterinary Use (CVMP) 5 6 7 Guideline on setting specifications
More informationGuide. recombinant DNA proteins. for the elaboration of monographs on synthetic peptides and. European Pharmacopoeia
Guide for the elaboration of monographs on synthetic peptides and recombinant DNA proteins European Pharmacopoeia European Directorate for the Quality of Medicines & HealthCare Edition Council of Europe,
More informationThe European Approach on Large Sample Sizes in the context of a PAT Environment
The European Approach on Large Sample Sizes in the context of a PAT Environment Dr. Michael Wierer, Deputy Head, European Pharmacopoeia Department, European Directorate for the Quality of Medicines & HealthCare
More informationEMPROVE For Raw and Starting Materials & For Filtration Devices and Single Use Systems. Jan Thomsen Warsaw, November 15 th, 2016
EMPROVE For Raw and Starting Materials & For Filtration Devices and Single Use Systems Jan Thomsen Warsaw, November 15 th, 2016 2 Content Emprove - An Introduction Emprove for Raw and Starting Materials
More informationImplementation strategy of ICH Q3D guideline
08 March 2017 EMA/CHMP/QWP/115498/2017 Committee for Medicinal Products for Human use (CHMP) Draft agreed by QWP and BWP June 2016 Adopted by CHMP for release for consultation June 2016 Start of public
More informationGuide to the investigational medicinal product dossier
Guide to the investigational medicinal product dossier Item type Authors Publisher Other Irish Medicines Board (IMB) Irish Medicines Board (IMB) Downloaded 1-May-2018 07:31:12 Link to item http://hdl.handle.net/10147/96980
More informationEuropean reflections on reviewing NDAs and ANDAs for ICH Q3D elemental impurity compliance
European reflections on reviewing NDAs and ANDAs for ICH Q3D elemental impurity compliance Diana van Riet-Nales, Medicines Evaluation Board/NL NL CHMP/CVMP Quality Working Party delegate (humans) Former
More informationAPPLICATION FOR VARIATION TO A MARKETING AUTHORISATION
Version: February 2018 APPLICATION FOR VARIATION TO A MARKETING AUTHORISATION HUMAN VETERINARY NATIONAL AUTHORISATION IN MRP Variation procedure number(s) 1 :... NATIONAL AUTHORISATION EU AUTHORISATION
More informationHow to build a good CEP application - ICH Q3D
How to build a good CEP application - ICH Q3D Lisa Moore B.Sc. (Pharm), MPSI Pharmaceutical Assessor, HPRA, Ireland External Expert CEP assessor. The place of the Certification Procedure in the global
More informationExperience with Health Canada s Approach for Post-Approval Changes. Kiran Krishnan Vice President US Regulatory Affairs September 2014
Experience with Health Canada s Approach for Post-Approval Changes Kiran Krishnan Vice President US Regulatory Affairs September 2014 Important Quotes to consider Dr. Janet Woodcock on desired state: A
More informationMASTER FILE PROCEDURES
MASTER FILE PROCEDURES Natural Health Products Directorate August 2006 Version 1.0 Our mission is to help the people of Canada maintain and improve their health, while respecting individual choices and
More informationGUIDELINES ON THE PHARMACEUTICAL & ANALYTICAL DATA REQUIRED FOR REGISTRATION OF STOCK REMEDIES IN SOUTH AFRICA
GUIDELINES ON THE PHARMACEUTICAL & ANALYTICAL DATA REQUIRED FOR REGISTRATION OF STOCK REMEDIES IN SOUTH AFRICA Issued by the Registrar: Act No. 36 of 1947, Private Bag X343, Pretoria 0001 Republic of South
More informationDIFFERING CMC REQUIREMENTS: US AND EU
WHITEPAPER DIFFERING CMC REQUIREMENTS: US AND EU Torsten Schnetgoeke M.Sc. Senior Manager, Regulatory Affairs torsten.schnetgoeke@pharmalex.com Torsten joined PharmaLex in 2015 as a Senior Manager in Regulatory
More informationMedicines Control Authority of Zimbabwe
EFV... QUALITY INFORMATION SUMMARY (QIS) FOREWORD The Quality Information Summary (QIS) template should be completed to provide a condensed summary of the key quality information for product dossiers (PDs)
More informationPublic Assessment Report. Scientific discussion. Lacidipine Double-e Pharma 2 mg, 4 mg and 6 mg film-coated tablets. (lacidipine)
Public Assessment Report Scientific discussion Lacidipine Double-e Pharma 2 mg, 4 mg and 6 mg film-coated tablets (lacidipine) NL/H/2992/001-003/DC Date: 28 July 2016 This module reflects the scientific
More informationAPPLICATION FOR VARIATION TO A MARKETING AUTHORISATION
July 2013 APPLICATION FOR VARIATION TO A MARKETING AUTHORISATION HUMAN VETERINARY NATIONAL AUTHORISATION IN MRP Variation procedure number(s) 1 :... EU AUTHORISATION NATIONAL AUTHORISATION Reference Member
More informationDRAFT GUIDANCE DOCUMENT ADDENDUM - Quality (Chemistry and Manufacturing) Guidance: Questions and Answers
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 DRAFT GUIDANCE DOCUMENT ADDENDUM - Quality (Chemistry and Manufacturing) Guidance: Questions and Answers This guidance document is being distributed for comment
More informationGuideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission
1 2 3 25 April 2014 EMA/CHMP/BWP/187338/2014 Committee for Medicinal Products for Human Use (CHMP) 4 5 6 7 Guideline on process validation for the manufacture of biotechnology-derived active substances
More informationSetting Specifications for Biotech Products
Setting Specifications for Biotech Products Session 1: What to Control? Presentation by an EU Regulator Nanna Aaby Kruse, Senior Biological Assessor, member of BWP and BMWP WHAT TO CONTROL? Control of
More informationGedanken eines Qualitätsgutachters Die Wahl der QUAL
Gedanken eines Qualitätsgutachters Die Wahl der QUAL Dr. Peter Platzer Abteilungsleiter Arzneimittelqualität (QUAL) AGES Gespräch Österreich als RMS (Reference Member State) Wien, 03.10.2013 www.basg.gv.at
More informationStrategies for IND Filing Success: Chemistry, Manufacturing and Controls
Strategies for IND Filing Success: Chemistry, Manufacturing and Controls October 21, 2016 Presented by: Sharon Ayd, Ph.D., MBA Chief Scientific Officer and SVP, Pharmaceuticals document contains proprietary
More informationDraft agreed by Quality Working Party 7 June Adopted by CHMP for release for consultation 28 June 2018
1 13 November 2018 2 EMA/CHMP/CVMP/QWP/496873/2018 3 4 Committee for Medicinal Products for Human Use (CHMP) 5 Committee for Medicinal Products for Veterinary Use (CVMP) 6 7 8 Draft Draft agreed by Quality
More informationFuture of Question-based Review and Regulatory Submissions
Future of Question-based Review and Regulatory Submissions Robert Iser Associate Director for Policy Development (Acting) Office of Pharmaceutical Science / CDER / FDA FDA/PQRI Conference on Evolving Product
More informationVariation Regulations (EU)
Variation Regulations (EU) Headlines of the Update APIC c view Hilde Vanneste APIC Task Force leader Hilde.Vanneste@its.jnj.com 1 Content Scope of regulation: Type of procedures and hence 2 strands Current
More informationPHARMACEUTICAL SCIENCES - QUESTIONS AND ANSWERS
PHARMACEUTICAL SCIENCES - QUESTIONS AND ANSWERS The document PHARMACEUTICAL SCIENCES - QUESTIONS AND ANSWERS is intended to provide clarification on a number of issues that relate to Quality (e.g., Chemistry
More information11 th INTERNATIONAL SYMPOSIUM ON PHARMACEUTICAL REFERENCE STANDARDS. Siriphorn Laomanacharoen 21 December 2012
11 th INTERNATIONAL SYMPOSIUM ON PHARMACEUTICAL REFERENCE STANDARDS Siriphorn Laomanacharoen 21 December 2012 11 th INTERNATIONAL SYMPOSIUM ON PHARMACEUTICAL REFERENCE STANDARDS Organised by European Directorate
More informationAPPLICATION FOR VARIATION TO A MARKETING AUTHORISATION
December 200 APPLICATION FOR VARIATION TO A MARKETING AUTHORISATION HUMAN VETERINARY NATIONAL AUTHORISATION IN MRP Variation procedure number(s) 1 :... EU AUTHORISATION NATIONAL AUTHORISATION Reference
More information