GUIDELINE ON SUBMISSION OF …

1 Working document 2010-08-10 RESTRICTED 1 2 GUIDELINE ON SUBMISSION OF DOCUMENTATION FOR 3 A MULTISOURCE (GENERIC) FINISHED 4 PHARMACEUTICAL PRODUCT (FPP): 5 PREPARATION OF PRODUCT DOSSIERS (PDS) 6 IN COMMON TECHNICAL DOCUMENT (CTD) FORMAT 7 8 DRAFT FOR COMMENT 9 10 11 12 13 World Health Organization 2010 14 All rights reserved.

2 15 This draft is intended for a restricted audience only, the individuals and organizations having received this draft. The draft 16 may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in 17 any form or by any means outside these individuals and organizations (including the organizations' concerned staff and 18 member organizations) without the permission of the World Health Organization. The draft should not be displayed on any 19 web site. 20 Please send any request for permission to: 21 Dr.

3 M. Stahl, Quality Assurance & Safety: Medicines, Department of Medicines Policy and Standards, World Health 22 Organization, CH-1211 Geneva 27, Switzerland. Fax: (41-22) 791 4730; e-mail: 23 The designations employed and the presentation of the material in this draft do not imply the expression of any opinion 24 whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or 25 of its authorities, or concerning the delimitation of its frontiers or boundaries.

4 Dotted lines on maps represent approximate 26 border lines for which there may not yet be full agreement. 27 The mention of specific companies or of certain manufacturers products does not imply that they are endorsed or 28 recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors 29 and omissions excepted, the names of proprietary products are distinguished by initial capital letters. 30 All reasonable precautions have been taken by the World Health Organization to verify the information contained in this 31 draft.

5 However, the printed material is being distributed without warranty of any kind, either expressed or implied. The 32 responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health 33 Organization be liable for damages arising from its use. 34 This draft does not necessarily represent the decisions or the stated policy of the World Health Organization. 35 Please address comments on this proposal, by 23 September 2010. All comments should be sent to Dr. M. Stahl , Quality Assurance & Safety: Medicines, Essential Medicines and Pharmaceutical Policies, World Health Organization, 1211 Geneva 27, Switzerland, fax: (+41 22) 791 4730 or e-mail: Working document page 2 SCHEDULE FOR THE PROPOSED ADOPTION PROCESS OF DOCUMENT 36 : 37 38 Drafting of GUIDELINE by G.

6 Condran and L. Paleshnuik 7 June 2010 Discussion and review within the Prequalification Programme assessment group June 2010 Consolidation of comments + Review July 2010 Circulation of revised draft for comments August 2010 Presentation to the forty-fifth WHO Expert Committee on Specifications for Pharmaceutical Preparations 18-22 October 2010 Any further action as required .. Working document page 3 39 CONTENTS 40 page 41 42 1.

7 43 Background 44 Objectives 45 Scope 46 General principles 47 48 2. Glossary ..6 49 50 3. Organization of a product dossier for a multisource pharmaceutical product in 51 common technical document (CTD) format ..6 52 53 4. Modules (including Module 1) of a product dossier for a multisource 54 pharmaceutical 55 56 5. Module 3 - Quality .. 10 57 58 6. Module 5 of a product dossier for a multisource pharmaceutical product ..10 59 60 7. Guidance on format and presentation of a product dossier in CTD format.

8 11 61 Guidance on format 62 Guidance on presentation 63 64 8. 65 66 9. References ..12 67 68 Working document page 4 69 1. INTRODUCTION 70 Background 71 72 WHO Technical Report Series, No. 953 (TRS No. 953), Annex 3 (2009) entitled Procedure 73 for Prequalification of Pharmaceutical Products outlines the procedure and considerations for 74 the process undertaken by WHO in providing United Nations agencies with advice on the 75 acceptability in principle of pharmaceutical products for procurement by such agencies.

9 TRS 76 No. 953 states: 77 This activity of WHO aims to facilitate access to priority essential medicines that meet 78 WHO-recommended norms and standards of acceptable quality. 79 As mentioned in TRS No. 953, in submitting an expression of interest (EOI) for product 80 evaluation, the applicant should send to the WHO focal point (together with the other data 81 requirements) a product dossier (PD), in the format specified in the WHO guidance 82 documents on submitting product data and information. 83 84 Through the International Conference on Harmonisation (ICH) process, considerable 85 harmonization has been achieved on the organization of the registration documents with the 86 issuance of the common technical document (CTD) GUIDELINE .

10 This recommended format in 87 the CTD GUIDELINE for registration applications has become widely accepted by regulatory 88 authorities both within and beyond the ICH Regions. 89 90 This document, GUIDELINE on SUBMISSION of documentation for a multisource (generic) 91 finished pharmaceutical product (FPP): Preparation of product dossiers (PDs) in common 92 technical document (CTD) format, provides recommendations on the format and presentation 93 for these types of PDs. 94 95 Objectives 96 97 This GUIDELINE is intended to: 98 99 assist applicants on the preparation of PDs for multisource products by providing clear 100 general guidance on the format of these dossiers; 101 102 fully adopt the modular format of the CTD as developed by ICH; and 103 104 provide guidance on the location of regional information (Module 1) and other general 105 data requirements.