Speeding up access to markets: WHO Expert Review Panel & WHO accelerated registration procedure How manufacturers, procurers and patients benefit

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Speeding up access to markets: WHO Expert Review Panel & WHO accelerated registration procedure How manufacturers, procurers and patients benefit"

Transcription

1 Speeding up access to markets: WHO Expert Review Panel & WHO accelerated registration procedure How manufacturers, procurers and patients benefit JOINT UNICEF, UNFPA & WHO MEETING WITH MANUFACTURERS AND SUPPLIERS OF DIAGNOSTIC PRODUCTS, FINISHED PHARMACEUTICAL PRODUCTS AND ACTIVE PHARMACEUTICAL INGREDIENTS September 2013 Dr Joelle DAVIAUD, Quality Assurance Specialist

2 ERP (Expert Review Panel) Outline for pharmaceuticals Background/Fundamental principles Eligibility criteria ERP risk categories ERP experience so far Concluding remarks

3 Expert Review Panel (ERP) for pharmaceuticals GF TOR for ERP approved by GF in March 2009; ERP established in April 2009 together with WHO. Objective: To review the potential risk/benefit for FPPs not yet WHOprequalified or SRA-authorized, for the purpose of providing advise to help procurement decisions ERP risk categories developed by QSM/WHO. ERP is coordinated by the QSM/WHO ERP reviews are done by experienced regulatory professionals

4 Expert Review Panel mechanism (ERP) A panel of regulatory experts (hosted by WHO) assesses the potential risks/benefits associated with the use of medicines that are not yet WHO-prequalified or SRA-authorized and provides recommendation (eligibility criteria: GMP and pending PQ/SRA application, if not justified otherwise) Assesses in 6-8 weeks abbreviated product dossiers submitted by manufacturers (GMP, questionnaire + annexes) Makes time limited recommendations: validity maximum 12 months. Can be extended only under certain circumstances ERP status does not replace WHO PQ/SRA approval but should be seen as a step towards WHO PQ/SRA approval 4

5 ERP - Eligibility criteria Criteria 1 (products included in WHO PQP EOI or eligible for SRA/Pepfar submission) A product dossier has been submitted to PQP or SRA/Pepfar and is accepted for assessment The FPP manufacturing site is compliant with Good Manufacturing Practices (GMP) as certified by WHO PQP, SRA or PIC/S inspectors. Criteria 2 (products not included in WHO PQP EOI or eligible for SRA/Pepfar submission) The FPP manufacturing site is compliant with GMP as certified by WHO PQP, SRA or PIC/S inspectors.

6 ERP Review Process EOI publication: January & July Invitation by GF/ GDF EoI or ad-hoc request ERP evaluation within 6-8 weeks ERP report: May and November ERP coordinator: Organize a session Mfg dossiers submission: March & Sept (2 months) Conclusions sent to Mfg: June & December 2 weeks after ERP report receipt Submission by manufacturers GF: Eligibility screening GF to review the report and send conclusions to GDF and to the manufacturers, update the GF list ERP: Confirm eligibility ERP: Review submissions Prepare reports incl risk categories ERP coordinator: prepare final communication Report to GF Pool of experts GMP status (confirmation by PQP inspectors)

7 Major attributes for risk categorization The following major product attributes are used as a basis for comparing the products: a. GMP status of the manufacturing site - one of the eligibility criteria for ERP review b. FPP manufacturing process and FPP specification c. Stability data d. Evidence of therapeutic equivalence e. API source and API quality

8 Common reasons for rejection by ERP API manufacturer not compliant Efficacy data not submitted (anti-tb products) Unsatisfactory efficiency data: several major deficiencies (especially anti-tb products) Unsatisfactory specification, e.g. limits for impurities (especially ARV) Unacceptable comparator product Unsatisfactory stability results, e.g. out-of-limit results Insufficient stability data, e.g. from one batch only (especially ARVs)

9 ERP - possible outcomes of review "No objection" against procurement (Risk categories 1 or 2) "Objection" against procurement (Risk categories 3* or 4) Request for additional data * Risk category 3 can be considered only if there is no other option and the risks of not treating the disease is higher than the risk of using medicines not meeting all quality standards.

10 ERP experience and impact on access to assured quality products 9 rounds completed in May 2013, leading to a huge increase of products prequalified specifically for TB products in 2012 ARV T B Malaria ERP submis ERP submiss ERP WHO/S submis sion cat 1/2 WHO/SRA ion cat 1/2 RA sion cat 1/2 WHO/S RA (6) (27) ( 20) ( 8)

11 Impact of ERP status on procurement Notifications received for ERP reviewed products ARV 3 notifications 2 countries 3 Products NONE 1 notification 1 country 1 product 2 notifications 2 countries 2 products 2 notifications 2 countries 2 products MALARIA 29 notifications 12 countries 15 products 49 notifications 25 countries 18 products 33 notifications 17 countries 9 products 11 notifications 6 countries 6 products 8 notifications 5 countries 4 products TB 2 notifications 1 country 2 products (FLD) 77 notifications 32 countries 12 products (FLD) 93 notifications 50 countries 25 products (22FLD,3SLD) 63 notifications 41 countries 16 products (12FLD,4SLD) 9 notifications 2 countries 11 products (9FLD,2SLD)

12 Harmonization of quality standards save cost and time for manufacturers and buyers Alignment of GDF and UNITAID QA policies with GF QA Uniform stringent standards easy reference for countries/ users Unique message for manufacturers Common Expression of interest for ERP review Common Expert Review Panel (ERP) assessment Common pre-shipment Quality Control testing

13 ERP experience so far Extension of same ERP mechanism to other products/ Harmonisation between organisation 10 ERP sessions for GF, first session started in Feb 2009 Joint EOI GF-UNITAID in Dec ERP reviews for UNITAID started Sept Joint EOI GF-GDF in July 2010 (GDF aligned their QA policy with that of GF). ERP reviews for Neglected Tropical Diseases, NTD (WHO) (started April 2010) ERP reviews for Reproductive Health products (UNFPA) started ERP reviews to advice on extension of the validity period (progress of dossiers?) ERP reviews of variations to prequalified and SRA approved products. Outcomes are today used by: Global Fund; GDF; UNITAID, UNFPA; MSF; The Union; ICRC; UNICEF Equivalent process under discussion for diagnostics

14 Recommendations to manufacturers To ensure availability of adequate( medicine/formulation) products to patients Submit dossier to WHO Prequalification program and /or SRA Submit dossier for ERP review for the medicines/formulations for which not enough products are currently on the market ( refer to EoI published by WHO PQ and GF/GDF, GF/UNITAID ) Respond as soon as possible to WHO PQ questions as ERP is temporary solution To ensure efficient ERP process and increase number of products on the market : Ensure that all required details are provided, in full, in the submission. The recommendations of the ERP after review of the dossier, shall be compiled with, in full, during the next submission. Where additional data are requested, the same shall be provided, in full, to avoid unnecessary back and forth communications. To ensure appropriate Quality control testing/quality monitoring: Provide all necessary information to PRs to conduct quality control testing.

15 Ensuring availability of needed products Key benefit of ERP Securing the supply of needed products: Number of products early available on the market Most of products ERP reviewed became WHO PQ or SRA approved within 12 months: Accelerate availability of WHOPQ/SRA products Increase access by patients to affordable products of assured quality: Linezolid case, reduction of price from 75 $ to less than 2$ A single process with unified requirements : ERP conclusion/process recognized today by most of partners: Work towards harmonization of quality standards between partners National Program recognized ERP review added value: Indian TB program decided to procure ERP products This has helped to achieve shorter lead times and competitive prices Future perspectives :ERP reviews of additional essential medicines

16 THANK YOU

Pharmaceuticals Procurement Global Fund s requirements and past funding

Pharmaceuticals Procurement Global Fund s requirements and past funding Pharmaceuticals Procurement Global Fund s requirements and past funding JOINT UNICEF PHARMACEUTICAL SUPPLIER MEETING & WHO PREQUALIFICATION OF MEDICINES PROGRAMME 3rd MEETING WITH MANUFACTURERS OF FINISHED

More information

EXPERT REVIEW PANEL PROCEDURE: ADDITIONAL SUPPORT TO PROCUREMENT AGENCIES UNDER EXCEPTIONAL CIRCUMSTANCES

EXPERT REVIEW PANEL PROCEDURE: ADDITIONAL SUPPORT TO PROCUREMENT AGENCIES UNDER EXCEPTIONAL CIRCUMSTANCES EXPERT REVIEW PANEL PROCEDURE: ADDITIONAL SUPPORT TO PROCUREMENT AGENCIES UNDER EXCEPTIONAL CIRCUMSTANCES Introduction The WHO Prequalification of Medicines Programme (PQP) was established to provide UN

More information

UNICEF s Quality Assurance System for procurement of medicines

UNICEF s Quality Assurance System for procurement of medicines UNICEF s Quality Assurance System for procurement of medicines QA Specialist Peter Svarrer Jakobsen Joint UNICEF, UNFPA and WHO Meeting with Manufacturers and Suppliers UN City, Copenhagen 23 September

More information

A rapid quality risk assessment mechanism for assessing needed pharmaceutical products that have not completed a stringent assessment

A rapid quality risk assessment mechanism for assessing needed pharmaceutical products that have not completed a stringent assessment Briefing paper: 27 April 2012 Expert Review Panel A rapid quality risk assessment mechanism for assessing needed pharmaceutical products that have not completed a stringent assessment WHO prequalification

More information

Global Fund Quality Assurance for Diagnostics

Global Fund Quality Assurance for Diagnostics Global Fund Quality Assurance for Diagnostics AIDS MEDICINES AND DIAGNOSTICS (AMDS) ANNUAL STAKEHOLDERS AND PARTNERS MEETING 29 30 September 2014 Dr Joelle DAVIAUD Quality Assurance Specialist Grant Management

More information

Annex 3 Procedure for prequalification of pharmaceutical products

Annex 3 Procedure for prequalification of pharmaceutical products World Health Organization WHO Technical Report Series, No. 953, 2009 Annex 3 Procedure for prequalification of pharmaceutical products 1. Introduction 2. Glossary 3. Purpose and principles 4. Steps of

More information

Annex 10 Procedure for prequalification of pharmaceutical products

Annex 10 Procedure for prequalification of pharmaceutical products World Health Organization WHO Technical Report Series, No. 961, 2011 Annex 10 Procedure for prequalification of pharmaceutical products 1. Introduction 2. Glossary 3. Purpose and principles 4. Steps of

More information

Session 6: WHO Prequalification Programme. Key Process Steps WHO: Medicines UNFPA: Condoms and IUDs

Session 6: WHO Prequalification Programme. Key Process Steps WHO: Medicines UNFPA: Condoms and IUDs Session 6: WHO Prequalification Programme Key Process Steps WHO: Medicines UNFPA: Condoms and IUDs Session adapted from the WHO training workshop on prequalification and the WHO technical briefing seminar

More information

Procurement and Supply Management

Procurement and Supply Management November 2009 Guide to the Global Fund s Policies on Procurement and Supply Management List of Terms ARVs ERP GDF GLC LFA PR PSM TB TRIPS UNDP UNFPA UNICEF WHO WHOPES antiretrovirals Expert Review Panel

More information

GUIDELINE ON ACTIVE PHARMACEUTICAL INGREDIENT MASTER FILE (APIMF) PROCEDURE 1 (The APIMF procedure guideline does not apply to biological APIs.

GUIDELINE 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 information

Unedited version adopted by the 45th WHO Expert Committee on specifications for pharmaceutical preparations. World Health Organization 2010

Unedited 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 information

The Global Fund experience on malaria RDTs. Rationale to enhance harmonization

The Global Fund experience on malaria RDTs. Rationale to enhance harmonization The Global Fund experience on malaria RDTs Rationale to enhance harmonization Stakeholder Consultation on enhanced Harmonization of malaria Rapid Diagnostic Tests 3rd 5th December 2013, Antwerp (Belgium)

More information

UNICEF s Quality Assurance System for Procurement of Micronutrient Powders (MNP)

UNICEF s Quality Assurance System for Procurement of Micronutrient Powders (MNP) UNICEF s Quality Assurance System for Procurement of Micronutrient Powders (MNP) Nutrition Supplier Meeting, June 30, 2015 Dimitris Catsoulacos Quality Assurance Specialist PRESENTATION OVERVIEW Quality

More information

WHO PREQUALIFICATION IN NIGERIA PHARMA INDUSTRY PERSPECTIVE CHIEF OLUBUNMI OLAOPA OCTOBER 30, 2013

WHO PREQUALIFICATION IN NIGERIA PHARMA INDUSTRY PERSPECTIVE CHIEF OLUBUNMI OLAOPA OCTOBER 30, 2013 WHO PREQUALIFICATION IN NIGERIA PHARMA INDUSTRY PERSPECTIVE CHIEF OLUBUNMI OLAOPA OCTOBER 30, 2013 OUTLINE NIGERIAN PHARMA SECTOR PRINCIPLE OF WHO PREQUALIFICATION PRODUCTS OF INTEREST FOR WHO PQP PROCESS

More information

Guidance for Industry: Starting Material Supplier Management

Guidance for Industry: Starting Material Supplier Management Guidance for Industry: Starting Material Supplier Management Version 1.0 Drug Office Department of Health. Contents 1. Introduction... 3 2. Purpose of this document... 3 3. Scope... 3 4. Selecting and

More information

OVERVIEW OF THE PREQUALIFICATION OF DIAGNOSTICS ASSESSMENT PROCESS. Prequalification of Diagnostics

OVERVIEW OF THE PREQUALIFICATION OF DIAGNOSTICS ASSESSMENT PROCESS. Prequalification of Diagnostics D i a g n o s t i c s a n d L a b o r a t o r y T e c h n o l o g y OVERVIEW OF THE PREQUALIFICATION OF DIAGNOSTICS ASSESSMENT PROCESS Prequalification of Diagnostics PQDx_007 v3 20 April 2010 Table of

More information

World Health Organization Prequalification of Medicines

World Health Organization Prequalification of Medicines Dr André van Zyl World Health Organization Prequalification of Medicines Manufacturers meeting April 2011 Head of Inspections vanzyla@who.int 1 WHO GMP In this presentation: Background and Introduction

More information

GUIDE TO GLOBAL FUND POLICIES ON. Procurement and Supply Management of Health Products JUNE 2012

GUIDE TO GLOBAL FUND POLICIES ON. Procurement and Supply Management of Health Products JUNE 2012 GUIDE TO GLOBAL FUND POLICIES ON Procurement and Supply Management of Health Products JUNE 2012 The Global Fund to Fight AIDS, Tuberculosis and Malaria The geographical designations employed in this publication

More information

Round 15-March 2016. Scope of the EoI: Anti-Retroviral (HIV/AIDs, Hepatitis B and C), anti-tuberculosis and anti- Malarial products

Round 15-March 2016. Scope of the EoI: Anti-Retroviral (HIV/AIDs, Hepatitis B and C), anti-tuberculosis and anti- Malarial products Global Fund, GDF and UNITAID Invitation to manufacturers of anti-retroviral, anti-tuberculosis and anti-malarial medicines to submit an Expression of Interest (EoI) for product evaluation by Expert Review

More information

ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION

ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 038-1 26 March 2012 AIDE-MEMOIRE ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION PIC/S March 2012 Reproduction

More information

Annex 6. Guidance on variations to a prequalified product dossier. Preface

Annex 6. Guidance on variations to a prequalified product dossier. Preface Annex 6 Guidance on variations to a prequalified product dossier Preface This guidance document was technically and structurally inspired by the Guideline on dossier requirements for type IA and IB notifi

More information

Industry Implications of Pharmaceutical Quality ICH Guidelines

Industry Implications of Pharmaceutical Quality ICH Guidelines EIPG General Assembly Industry Implications of Pharmaceutical Quality ICH Guidelines 20 th April 2008 Pharmaceutical Quality Develop a harmonised pharmaceutical quality system applicable across the lifecycle

More information

The WHO Prequalification of Medicines Programme

The WHO Prequalification of Medicines Programme The WHO Prequalification of Medicines Programme CPTR 2013 Workshop, Washington 1-3 Oct 2013 Dr M Stahl Head of Assessments, Prequalification of Medicines Programme WHO 1 The Prequalification of Medicines

More information

PROPOSED UPDATED TEXT FOR WHO GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS: MAIN PRINCIPLES (JANUARY 2013)

PROPOSED UPDATED TEXT FOR WHO GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS: MAIN PRINCIPLES (JANUARY 2013) January 2013 RESTRICTED PROPOSED UPDATED TEXT FOR WHO GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS: MAIN PRINCIPLES (JANUARY 2013) DRAFT FOR COMMENTS Please address any comments on this proposal

More information

Workshop: C. System. Implementation of ICH Q8, Q9, Q10

Workshop: C. System. Implementation of ICH Q8, Q9, Q10 Implementation of ICH Q8, Q9, Q10 Workshop: C Pharmaceutical Quality System International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Disclaimer

More information

GOOD DOCUMENTATION AND QUALITY MANAGEMENT PRINCIPLES. Vimal Sachdeva Technical Officer (Inspector), WHO Prequalification of Medicines Programme

GOOD DOCUMENTATION AND QUALITY MANAGEMENT PRINCIPLES. Vimal Sachdeva Technical Officer (Inspector), WHO Prequalification of Medicines Programme GOOD DOCUMENTATION AND QUALITY MANAGEMENT PRINCIPLES Vimal Sachdeva Technical Officer (Inspector), WHO Prequalification of Medicines Programme Contents 1. Why good documentation is essential? 2. What constitutes

More information

Qualified Persons in the Pharmaceutical Industry Code of Practice 2009, updated August 2015

Qualified Persons in the Pharmaceutical Industry Code of Practice 2009, updated August 2015 Qualified Persons in the Pharmaceutical Industry Code of Practice 2009, updated August 2015 *QP Code of Practice 2008 updated Aug15 Page 1 of 13 Code of Practice for Qualified Persons 1. INTRODUCTION 2.

More information

MEDICINES CONTROL COUNCIL

MEDICINES CONTROL COUNCIL ectd VALIDATION and TECHNICAL VERIFICATION MEDICINES CONTROL COUNCIL VALIDATION TEMPLATE FOR APPLICATIONS FOR REGISTRATION IN ectd format The Validation Template is to be used on receipt of an application

More information

PROGRAMME UPDATE FOR 2006

PROGRAMME UPDATE FOR 2006 WHO PREQUALIFICATION OF MEDICINES PROGRAMME UPDATE FOR 2006 VITAL TO HEALTH GOALS Imagine carrying your weak and feverish child to the nearest health clinic. Imagine the doctor making his diagnosis and

More information

Annex 4. Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection

Annex 4. Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection Annex 4 Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection 1. Introduction 294 2. Purpose 294 3. Scope 294 4. Assessment tool 295 293 WHO

More information

Quality Assurance. Disclosure for Lilli Møller Andersen. No relevant financial relationships exist for any issue mentioned in this presentation

Quality Assurance. Disclosure for Lilli Møller Andersen. No relevant financial relationships exist for any issue mentioned in this presentation Quality Assurance Disclosure for Lilli Møller Andersen No relevant financial relationships exist for any issue mentioned in this presentation Agenda Quality Assurance Quality Management System Quality

More information

Brazil s Model for SLDs Quality Assurance and Management: A Country Perspective. Joel Keravec MSH/SIAPS Brazil Country Director

Brazil s Model for SLDs Quality Assurance and Management: A Country Perspective. Joel Keravec MSH/SIAPS Brazil Country Director Brazil s Model for SLDs Quality Assurance and Management: A Country Perspective Joel Keravec MSH/SIAPS Brazil Country Director IOM Workshop Washington DC - July 2012 Brazil TB/DR-TB Context Size : 8,547,403

More information

ICH guideline Q10 on pharmaceutical quality system

ICH guideline Q10 on pharmaceutical quality system September 2015 EMA/CHMP/ICH/214732/2007 Committee for Human Medicinal Products Step 5 Transmission to CHMP May 2007 Transmission to interested parties May 2007 Deadline for comments November 2007 Final

More information

I N T E R A G E N C Y G U I D E L I N E S. a model quality assurance system for procurement agencies

I N T E R A G E N C Y G U I D E L I N E S. a model quality assurance system for procurement agencies I N T E R A G E N C Y G U I D E L I N E S a model quality assurance system for procurement agencies WHO/PSM/PAR/2007.3 a model quality assurance system for procurement agencies Recommendations for quality

More information

PHARMACEUTICAL QUALITY SYSTEM Q10

PHARMACEUTICAL QUALITY SYSTEM Q10 INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE PHARMACEUTICAL QUALITY SYSTEM Q10 Current Step

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)

COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP) European Medicines Agency Veterinary Medicines and Inspections London, 18 May 2006 Doc. Ref. EMEA/CVMP/32995/2006 COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP) GUIDELINE ON THE PROCEDURE FOR

More information

The Quality System for Drugs in Germany

The Quality System for Drugs in Germany The Quality System for Drugs in Germany Prof. Dr. Harald G. Schweim Head of Department for Drug Regulatory Affairs Institute for Pharmacy, University of Bonn Former President of the German Federal Institute

More information

Session 6: Enhancing Pharmaceutical Procurement. Michael Gabra

Session 6: Enhancing Pharmaceutical Procurement. Michael Gabra This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike License. Your use of this material constitutes acceptance of that license and the conditions of use of materials on this

More information

Pharmaceutical Wholesaler Site Inspection Checklist

Pharmaceutical Wholesaler Site Inspection Checklist Pharmaceutical Wholesaler Site Inspection Checklist Date and time of inspection: Legal business name and plant name: Location (address): Phone number: Fax number: Email address: Web site URL: Contact Person:

More information

Lifecycle CMC Management: ICH Q12 Progress to date

Lifecycle CMC Management: ICH Q12 Progress to date Lifecycle CMC Management: ICH Q12 Progress to date BWP/QWP/GMDP IWG Industry European workshop 28-29 October 2015 Jean-Louis ROBERT (EU) Graham Cook (EFPIA) Please take note The following slides represent

More information

Emergency Use Assessment and Listing Procedure (EUAL) for candidate vaccines for use in the context of a public health emergency

Emergency Use Assessment and Listing Procedure (EUAL) for candidate vaccines for use in the context of a public health emergency Emergency Use Assessment and Listing Procedure (EUAL) for candidate vaccines for use in the context of a public health emergency Introduction The 2014 Ebola outbreak is the largest Ebola epidemic in history,

More information

Iamey/AbWEST AFRICAN HEATH ORGANIZATION PROCEDURE GUIDELINE FOR THE MANAGEMENT OF THE REGIONAL ANTIRETROVIRAL DRUGS BUFFER STOCK

Iamey/AbWEST AFRICAN HEATH ORGANIZATION PROCEDURE GUIDELINE FOR THE MANAGEMENT OF THE REGIONAL ANTIRETROVIRAL DRUGS BUFFER STOCK Page 1 of 54 Iamey/AbWEST AFRICAN HEATH ORGANIZATION PROCEDURE GUIDELINE FOR THE MANAGEMENT OF THE REGIONAL ANTIRETROVIRAL DRUGS BUFFER STOCK Addressee: West African Heath Organization (WAHO), Central

More information

Food, Medicine and Health Care Administration and Control Authority

Food, 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 information

Auditing as a Component of a Pharmaceutical Quality System

Auditing as a Component of a Pharmaceutical Quality System Auditing as a Component of a Pharmaceutical Quality System Tim Fields Conducting internal audits (or self inspections) and external audits of suppliers and outsourcing operations are key elements of a

More information

Recent Updates on European Requirements and what QPs are expected to do

Recent Updates on European Requirements and what QPs are expected to do Recent Updates on European Requirements and what QPs are expected to do QP Forum 28/29 November 2013, Lisbon Dr. Bernd Renger Modified: Georg Goestl 1 Written Conformation for API-Import Actual Status

More information

The Ever-increasing Complexity of Biotech Changes - A Pledge for Global Convergence

The Ever-increasing Complexity of Biotech Changes - A Pledge for Global Convergence The Ever-increasing Complexity of Biotech Changes - A Pledge for Global Convergence CMC Strategy Forum, Sorrento, May 7th, 2014 Susanne Ausborn, Pharma Technical Regulatory Policy F. Hoffmann-La Roche,

More information

Workshop B Control Strategy

Workshop B Control Strategy ICH-GCG ASEAN Workshop B Control Strategy Jean-Louis ROBERT, Ph.D. National Health Laboratory, Luxembourg Chair-person ICH IWG Q8, Q9, Q10 Kuala Lumpur, 26-28 July 2010 International Conference on Harmonisation

More information

Update on Rotavirus Vaccine. Industry Consultation Meeting UNICEF Supply Division January 2012

Update on Rotavirus Vaccine. Industry Consultation Meeting UNICEF Supply Division January 2012 Update on Rotavirus Vaccine Industry Consultation Meeting UNICEF Supply Division 25-26 January 2012 Overview of presentation Update on country demand for Rotavirus Vaccine Procurement activities and results

More information

Working with ICH Quality Guidelines - the Canadian Perspective

Working with ICH Quality Guidelines - the Canadian Perspective Working with ICH Quality Guidelines the Canadian Perspective Krishnan Tirunellai, Ph. D. Bureau of Pharmaceutical Sciences Therapeutic Products Directorate Health Canada December 3, 2008 Outline Introduction

More information

The European Pharmacopoeia and certificates of suitability (CEP)

The European Pharmacopoeia and certificates of suitability (CEP) The European Pharmacopoeia and certificates of suitability (CEP) Your Logo Andrew McMath Ph.D. European Directorate for the Quality of Medicines (EDQM) Presented by: Andrew McMath Scientific Officer, EDQM

More information

Comparative analysis between the possible regulatory approaches to GMP compliance TITOLO PRESENTAZIONE

Comparative analysis between the possible regulatory approaches to GMP compliance TITOLO PRESENTAZIONE Comparative analysis between the possible regulatory approaches to GMP compliance TITOLO PRESENTAZIONE Dr. Fulvio CARLOTTI, GNOSIS SpA, Corporate QA Director September 26, 2014 Scope of GMP GMP compliance

More information

Annex 2 Stability testing of active pharmaceutical ingredients and finished pharmaceutical products

Annex 2 Stability testing of active pharmaceutical ingredients and finished pharmaceutical products World Health Organization WHO Technical Report Series, No. 953, 2009 Annex 2 Stability testing of active pharmaceutical ingredients and finished pharmaceutical products 1. Introduction 1.1 Objectives of

More information

The European regulatory system for medicines and the European Medicines Agency

The European regulatory system for medicines and the European Medicines Agency The European regulatory system for medicines and the European Medicines Agency A consistent approach to medicines regulation across the European Union An agency of the European Union This booklet is intended

More information

Harmonizing Change Control Processes Globally

Harmonizing Change Control Processes Globally Quality & Compliance Associates, LLC Harmonizing Change Control Processes Globally President Quality & Compliance Associates, LLC When We Deal In A Global Environment, How Do We Design A System That Addresses

More information

GMP/Regulatory Environment in the

GMP/Regulatory Environment in the GMP/Regulatory Environment in the Latin America Irene Ortiz Barreal, Pharm. D., R.Ph. Pfizer International Affiliate Quality Compliance Regional Leader Latin America/Caribbean April 14, 2011 Discloser

More information

Guidance for Industry. Q10 Pharmaceutical Quality System

Guidance for Industry. Q10 Pharmaceutical Quality System Guidance for Industry Q10 Pharmaceutical Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation

More information

Importing pharmaceutical products to China

Importing 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 information

Introduction to Q10 Pharmaceutical Quality System

Introduction to Q10 Pharmaceutical Quality System ICH-GCG Asean Training Workshop on ICH Guidelines Q8,Q9 and Q10 (New Paradigm) Introduction to Q10 Pharmaceutical Quality System Georges FRANCE, Q- IWG Kuala Lumpur, Malaysia 26-28 July 2010 International

More information

Provision of Accounts Payable Service

Provision of Accounts Payable Service Oman LNG LLC Pre-Qualification of Tenderers NGF-14-761 Provision of Accounts Payable Service GUIDELINES Response to this questionnaire shall be completed in English by a senior member of your company.

More information

QA for LN Procurement by UNICEF Supply Division

QA for LN Procurement by UNICEF Supply Division UNICEF Supply Division Copenhagen QA for LN Procurement by UNICEF Supply Division Jolanta Wozniak Quality Assurance Centre Agenda The UNICEF Supply Division Model UNICEF QA Introduction Inspections Regulatory

More information

HIV Rapid Test Kits USAID Approval and Technical Guidance June 17, 2013 Revision

HIV Rapid Test Kits USAID Approval and Technical Guidance June 17, 2013 Revision HIV Rapid Test Kits USAID Approval and Technical Guidance Revision Part 1 A. Introduction 1. This document contains the requirements for USAID evaluation and approval of HIV rapid test kits and related

More information

Overview of WHO revised vaccine prequalification procedure

Overview of WHO revised vaccine prequalification procedure Overview of WHO revised vaccine prequalification procedure Carmen Rodriguez WHO/IVB/QSS Vaccine Industry Consultation meeting 25-26 January 2012 UNICEF SD Copenhagen Purpose of WHO vaccines prequalification

More information

GLOBAL FUND QUALITY ASSURANCE POLICY FOR DIAGNOSTICS PRODUCTS. (Issued on 14 December 2010, amended on 5 February 2014)

GLOBAL FUND QUALITY ASSURANCE POLICY FOR DIAGNOSTICS PRODUCTS. (Issued on 14 December 2010, amended on 5 February 2014) GLOBAL FUND QUALITY ASSURANCE POLICY FOR DIAGNOSTICS PRODUCTS (Issued on 14 December 2010, amended on 5 February 2014) BASIC PRINCIPLES 1. Grant funds provided by the Global Fund may only be used to procure

More information

BEST PRACTICE GUIDE 3: TENDER PROCESSES AND TENDER DOCUMENTS. RDTL MINISTRY OF FINANCE Procurement Service

BEST PRACTICE GUIDE 3: TENDER PROCESSES AND TENDER DOCUMENTS. RDTL MINISTRY OF FINANCE Procurement Service RDTL MINISTRY OF FINANCE Procurement Service BEST PRACTICE GUIDE 3: TENDER PROCESSES AND TENDER DOCUMENTS 1 RDTL Procurement Guidelines The Procurement Legal Regime Decree Law sets out new procurement

More information

ICH guideline Q8, Q9 and Q10 - questions and answers volume 4

ICH guideline Q8, Q9 and Q10 - questions and answers volume 4 December 2010 EMA/CHMP/ICH/265145/ Committee for medicinal products for human use (CHMP) ICH guideline Q8, Q9 and Q10 - questions and answers volume 4 Step 5 Transmission to CHMP for information December

More information

Author General Management Quality Assurance

Author General Management Quality Assurance Lab Ofichem B.V. Pag.: 1 / 14 Date: 20-01- Version: 02 Status: geldig Contents 1. General... 2 2. Shared Third Party audit program... 3 3. Reassurance absence of Conflict of Interest... 5 4. Contract structure...

More information

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP) NOTE FOR GUIDANCE ON PROCESS VALIDATION

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP) NOTE FOR GUIDANCE ON PROCESS VALIDATION The European Agency for the Evaluation of Medicinal Products London, 1 March 2001 CPMP/QWP/848/96 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP)

More information

Annex 7 Guidelines on pre-approval inspections

Annex 7 Guidelines on pre-approval inspections World Health Organization WHO Technical Report Series, No. 902, 2002 Annex 7 Guidelines on pre-approval inspections 1. General 94 2. Glossary 94 3. Objectives 95 4. Priorities 96 5. Preparation for the

More information

Excipient Certification: Schemes and Auditable Standards - the role in Supplier Qualification

Excipient Certification: Schemes and Auditable Standards - the role in Supplier Qualification Excipient Certification: Schemes and Auditable Standards - the role in Supplier Qualification European Compliance Academy Hamburg 26th 27th April 2010 Dr Iain Moore Certification Committee IPEC Europe

More information

TRANSATLANTIC TRADE AND INVESTMENT PARTNERSHIP

TRANSATLANTIC TRADE AND INVESTMENT PARTNERSHIP DISCLAIMER: The EU reserves the right to make subsequent modifications to this text and to complement its proposals at a later stage, by modifying, supplementing or withdrawing all, or any part, at any

More information

VOLUME 2A Procedures for marketing authorisation CHAPTER 1 MARKETING AUTHORISATION. November 2005

VOLUME 2A Procedures for marketing authorisation CHAPTER 1 MARKETING AUTHORISATION. November 2005 EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, ENTR/F2/BL D(2002) NOTICE TO APPLICANTS Revision 3 VOLUME 2A Procedures for marketing authorisation CHAPTER 1

More information

Public Procurements. Where rules are defined. Tirana May27-28, 2013. ADRIARadNet 2nd Meeting

Public Procurements. Where rules are defined. Tirana May27-28, 2013. ADRIARadNet 2nd Meeting Where rules are defined Tirana May27-28, 2013 1 Suggested manuals INTERACT Point Vienna Public procurement in IPA cross-border cooperation programmes with EU Member States in shared management - Version

More information

Work plan for GMP/GDP Inspectors Working Group for 2016

Work plan for GMP/GDP Inspectors Working Group for 2016 21 December 2015 EMA/INS/GMP/738756/2015 Compliance and Inspection Work plan for GMP/GDP Inspectors Working Group for 2016 Chairperson: Status David Cockburn January 2016 1. Meetings scheduled for 2016

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 17 July 2006 Doc. Ref. EMEA/419127/05 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE PROCEDURE

More information

Market withdrawal and suspension of marketing authorisation of medicinal product due to good manufacturing practice noncompliance in India

Market withdrawal and suspension of marketing authorisation of medicinal product due to good manufacturing practice noncompliance in India Market withdrawal and suspension of marketing authorisation of medicinal product due to good manufacturing practice noncompliance in India C-269/13 Acino AG vs. European Commission, LS&R 885 Citeersuggestie:

More information

EUROPEAN INDUSTRIAL PHARMACISTS GROUP

EUROPEAN 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 information

Quality Implementation Working Group on Q8, Q9 and Q10 Questions & Answers (R4)

Quality Implementation Working Group on Q8, Q9 and Q10 Questions & Answers (R4) INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Quality Implementation Working Group on Q8, Q9 and Q10 & (R4) Current version dated

More information

Overview of Key Obligations Under Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP)

Overview of Key Obligations Under Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP) Overview of Key Obligations Under Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP) Summary This document examines the key aspects of the CLP

More information

U. Nitin Kashyap et al /J. Pharm. Sci. & Res. Vol.5(6), 2013,

U. Nitin Kashyap et al /J. Pharm. Sci. & Res. Vol.5(6), 2013, Comparison of Drug Approval Process in United States & Europe U. Nitin Kashyap, Vishal Gupta *, H. V. Raghunandan Pharmaceutical Quality Assurance Group, Department of Pharmaceutics, JSS College of Pharmacy,

More information

SUPPLIER PREQUALIFICATION QUESTIONNAIRE FORM

SUPPLIER PREQUALIFICATION QUESTIONNAIRE FORM SUPPLIER PREQUALIFICATION QUESTIONNAIRE FORM BRIEF This Supplier Pre Qualification Questionnaire is provided for the following project types of ALARGAN PROJECTS: 1) Supply of Construction Materials 2)

More information

Title:: Effective GMP AUDITS for APIs and Formulation Pharma Companies By G.Sundar-Director/Consultant PharmQA Compliance solutions

Title:: Effective GMP AUDITS for APIs and Formulation Pharma Companies By G.Sundar-Director/Consultant PharmQA Compliance solutions WELCOME Title:: Effective GMP AUDITS for APIs and Formulation Pharma Companies By G.Sundar-Director/Consultant PharmQA Compliance solutions Contents: Introduction GMP Audit GMP Audit plan GMP Auditing

More information

Procurement of Pneumococcal Vaccines under the Advance Market Commitment

Procurement of Pneumococcal Vaccines under the Advance Market Commitment Procurement of Pneumococcal Vaccines under the Advance Market Commitment Pre Tender Meeting UNICEF Supply Division, 10-11th December 2008 Ann Ottosen From 2009 and 2010, 11 GAVI-supported countries are

More information

Quality Agreement. by and between. Supplier Name. Address: and. Client Name: Address:

Quality Agreement. by and between. Supplier Name. Address: and. Client Name: Address: NOTE TO USERS This Quality Agreement template was developed by the Bulk Pharmaceutical Task Force (BPTF), an affiliate organization of the Society of Chemical Manufacturers and Affiliates (SOCMA), as a

More information

DEPARTMENT OF HEALTH DRUG OFFICE DRUG REGISTRATION AND IMPORT/EXPORT CONTROL DIVISION DRUG REGISTRATION UNIT

DEPARTMENT OF HEALTH DRUG OFFICE DRUG REGISTRATION AND IMPORT/EXPORT CONTROL DIVISION DRUG REGISTRATION UNIT DEPARTMENT OF HEALTH DRUG OFFICE DRUG REGISTRATION AND IMPORT/EXPORT CONTROL DIVISION DRUG REGISTRATION UNIT Guidance Notes on Change of Registered Particular(s) of Registered Pharmaceutical Product Registered

More information

FOR USE WITH PPP PROJECTS 1 SAMPLE GUIDELINES FOR PRE-QUALIFICATION AND COMPETITIVE BIDDING PROCESS 2

FOR USE WITH PPP PROJECTS 1 SAMPLE GUIDELINES FOR PRE-QUALIFICATION AND COMPETITIVE BIDDING PROCESS 2 FOR USE WITH PPP PROJECTS 1 SAMPLE GUIDELINES FOR PRE-QUALIFICATION AND COMPETITIVE BIDDING PROCESS 2 1. PRE-QUALIFICATION 1.1 The requirements for pre-qualifications will be reasonable and efficient and

More information

Scrip Regulatory Affairs

Scrip Regulatory Affairs Topical, authoritative and businesscritical coverage of pharmaceutical and medical device regulatory affairs SCRIP Regulatory Affairs provides you with topical, authoritative and business-critical coverage

More information

WHO Drug Information

WHO Drug Information WHO Drug Information Contents Quality Assurance Highlights Recovery of solvents in API manufacturing 221 Chewable tablets: time to reassess a neglected dosage form? 223 Pharmacopoeial Discussion Group:

More information

Working Party on Control of Medicines and Inspections. Final Version of Annex 15 to the EU Guide to Good Manufacturing Practice

Working Party on Control of Medicines and Inspections. Final Version of Annex 15 to the EU Guide to Good Manufacturing Practice EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market, regulatory environment, industries under vertical legislation Pharmaceuticals and cosmetics Brussels, July 2001 Working Party on Control

More information

Overview. Health Science Authority. Implementation of ICH guideline in Singapore. Singapore s experience

Overview. 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 information

SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT

SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT Guideline Title Specifications and Control Tests on the Finished Product Legislative basis Directive 75/318/EEC as amended Date of first adoption

More information

ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE (APIC) SUPPLIER QUALIFICATION & MANAGEMENT GUIDELINE

ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE (APIC) SUPPLIER QUALIFICATION & MANAGEMENT GUIDELINE ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE (APIC) SUPPLIER QUALIFICATION & MANAGEMENT GUIDELINE December 2009 Content 1. Introduction 2. Chapter 1: Supplier Selection 3. Chapter 2: Due Diligence 4. Chapter

More information

Annex 2. WHO guidelines on quality risk management. 1. Introduction 62. 2. Glossary 67 3. Quality risk management process 70

Annex 2. WHO guidelines on quality risk management. 1. Introduction 62. 2. Glossary 67 3. Quality risk management process 70 Annex 2 WHO guidelines on quality risk management 1. Introduction 62 1.1 Background and scope 62 1.2 Principles of quality risk management 64 2. Glossary 67 3. Quality risk management process 70 3.1 Initiating

More information

Workshop A Design Space (DS)

Workshop A Design Space (DS) Implementation of ICH Q8, Q9, Q10 Workshop A Design Space (DS) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Disclaimer The information

More information

Reduce risk. Reduce cost. Raise performance.

Reduce risk. Reduce cost. Raise performance. Reduce risk. Reduce cost. Raise performance. Services for professional procurement. Be better informed, make better decisions. Enterprise Supplier Management System (ESMS) Tiered pre-qualification for

More information

GOOD MANUFACTURING PRACTICE PRE-INSPECTION COMPLIANCE REPORT AND INTERIM COMPLIANCE REPORT GUIDELINES FOR COMPLETION AND SUBMISSION

GOOD MANUFACTURING PRACTICE PRE-INSPECTION COMPLIANCE REPORT AND INTERIM COMPLIANCE REPORT GUIDELINES FOR COMPLETION AND SUBMISSION Revision note: The previous report contained a combined use for the compliance report and interim compliance report. These have now been separated and renamed as, Pre-inspection Compliance Report and Interim

More information

Considerations for veterinary scientific advice and marketing authorisations

Considerations for veterinary scientific advice and marketing authorisations Considerations for veterinary scientific advice and marketing authorisations Presented by: Mary O Grady Irish Medicines Board An agency of the European Union Veterinary scientific advice Veterinary marketing

More information

Supplier s Tendering Guide

Supplier s Tendering Guide Alexandrina Council Supplier s Tendering Guide November 2015 C O N N E C T I N G C O M M U N I T I E S Introduction This guide has been developed to provide businesses with information to assist them in

More information

Presented by Rosemarie Bell 24 April 2014

Presented by Rosemarie Bell 24 April 2014 Global Good Manufacturing Practice A Comparability Study to Link Good Manufacturing Practice Standards for World Wide Compliance Within the Cellular Therapy Industry Presented by Rosemarie Bell 24 April

More information

The Shortage of Benznidazole Leaves Thousands of Chagas Patients without Treatment

The Shortage of Benznidazole Leaves Thousands of Chagas Patients without Treatment The Shortage of Benznidazole Leaves Thousands of Chagas Patients without Treatment Médecins Sans Frontières (MSF) has been combating Chagas disease since 1999 in a number of Latin American countries by

More information

This interpretation of the revised Annex

This interpretation of the revised Annex Reprinted from PHARMACEUTICAL ENGINEERING The Official Magazine of ISPE July/August 2011, Vol. 31 No. 4 www.ispe.org Copyright ISPE 2011 The ISPE GAMP Community of Practice (COP) provides its interpretation

More information