Assessment and Regulation of Medicines Health Products

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Assessment and Regulation of Medicines & Health Products Implementation of the CTD in Europe & EMEA Experiences FFUL Lisbon Hilde Boone 29 May 2003 EMEA 1

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Why CTD Industry activity/ask for ��  talked about at ICH level To accommodate a typical arrangement/layout for the accommodation of data to the regul atory dominant presences in the 3 ICH locales "Basic Technical Document" closed down by ICH in November 2000 2

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Why CTD Advantages/Objectives: Resource putting something aside for industry Facilitate concurrent accommodation in 3 areas Facilitate trade of administrative data Harmonized organization to be further bolstered by e-CTD More proficient appraisal; utilization of hyperlinks and so on… Faster accessibility of new medications 3

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Why CTD However, CTD is just a FORMAT ! It's not a "solitary" dossier , with a "solitary" substance since Legal prerequisites contrast in the 3 areas ICH rules have not yet orchestrated all necessities Pharmacopeias are not fit Applicant may have provincial inclinations 4

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Modular structure of CTD Part II Part III Part IV Quality Non-clinical Clinical    Module 3 Module 4 Module 5 Module 2 : composed + forbidden configurations ( replaces master reports) Module 1 : managerial, territorial information (not in that capacity part of the ICH CTD) 5

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Modular structure of CTD Module 2 : Quality Overall Summary Non-clinical Overview Clinical Overview Non-clinical Summaries (tables) Clinical Summaries (tables) To give a rundown of the improvement arrange and of the Q, S and E information To incorporate the most essential data To encourage the assignment of the assessor 6

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Modular structure of CTD Module 2 ought to give (a.o.) : Integrated & basic investigation of the key-parameters of the item Summary and examination of the principle tox/clin information Justifications for deviations from necessities and rules Non-clinical and clinical methodology utilized by organization Comment on GLP, GCP status of information submitted Benefit/chance conclusions Clear classified synopses of the tests/trials 7

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Modular structure of CTD Module 3-4-5 : Body of information/Study Reports + references Module 3 ��  2 primary parts: 3.2.S Drug Substance 3.2.P Drug Product Module 4-5: comparative structure to current configuration 8

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Module 1: Not Part of the CTD Content to be dictated by EU, US, JP powers Module 1 Regional Information 1.0 CTD Table of Contents 2.1 CTD Introduction 2.2 Module 2 Nonclinical Overview 2.4 Clinical Overview 2.5 Quality Overall Summary 2.3 Module 2-5 CTD Nonclinical Summaries 2.6 Clinical Summary 2.7 Module 3 Quality 3.0 Module 5 Clinical Study Reports 5.0 Module 4 Nonclinical Study Reports 4.0 9

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Implementation of CTD Each locale (US, EU, Japan) to bring CTD into enactment or direction As of July 2003 : Mandatory utilization of CTD for EU, Japan (MHLW) Highly prescribed for US (FDA) In EU: CTD reflected in Notice To Applicants (NTA) and in Legislation 10

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Why CTD actualized in NTA ? "old" Annex I to Directive 2001/83/EC: « … . Application … . might be exhibited in 4 sections… assessing direction distributed by EC in Notice To Applicants … .. » European Commission Publication (9 volumes): "Principles representing therapeutic items in the EU" http://pharmacos.eudra.org/F2/eudralex/index.htm Volume 1 = Community legislation Volume 2 = N otice T o A pplicants … 11

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2C 2A What is NTA ? Volume 2 = NTA * Volume 2A: Info on P rocedures for MA (direction, understanding) * Volume 2B : Presentation and substance of a MA dossier (organize format) * Volume 2C: Regulatory rules First distributed in 1986 - Regularly redesigned http://pharmacos . eudra.org/F2/eudralex/vol-2/home.htm 2B 12

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NTA - Volume 2 B Presentation & Content 2B 2C 2A " CTD " 5 Modules Current EU design for accommodation of utilization s 4 sections  Replace by new arrangement in view of CTD - 5 Modules «4 parts might be displayed as 5 modules» Volume 2B 2C 2A " NTA " R evised NTA fusing CTD: distributed 29 June 2001 13

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Module 1: Not Part of the CTD Content to be dictated by EU, US, JP powers Module 1 Regional Information 1.0 CTD Table of Contents 2.1 CTD Introduction 2.2 Module 2 Nonclinical Overview 2.4 Clinical Overview 2.5 Quality Overall Summary 2.3 Module 2-5 CTD Nonclinical Summaries 2.6 Clinical Summary 2.7 Module 3 Quality 3.0 Module 5 Clinical Study Reports 5.0 Module 4 Nonclinical Study Reports 4.0 14

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NTA CTD execution Topics to be tended to in EU Give EU particular direction in the Introduction Defining extension & application sorts Agree on Time outline for usage Defining Region-Specific things ��  C ontent of Module 1 Prepare FAQs archive Prepare correction of Directive 2001/83/EC to legitimately reflect CTD structure by July 2003 15

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NTA CTD execution Time-Frames NTA (CTD) Volume 2 distributed June 2001 July 2001 – July 2003 : TRANSITIONAL PERIOD Dossier can be exhibited utilizing the * 1998 NTA Vol. 2 B edition, or * 2001 NTA Vol. 2 B version Mixtures of both organizations between modules could be acknowledged, yet not inside parts/modules e.g. Q module 3 + S & E Parts III + IV 16

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Mixed organization applications See EC WebSite 17

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NTA CTD usage Time-Frames As of July 2003 : Mandatory for EU, Japan (MHLW) Hihgly prescribed for US (FDA) Commission to revise Relevant EU enactment to completely reflect CTD (Annex I to Dir. 2001/83/EC) New Annex I to be distributed SOON ! 18

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NTA CTD usage Scope Applicable to a wide range of EU strategies : - Centralized method - Decentralized (MR) system - National techniques Applicable to a wide range of items : - NCEs - Biologicals, biotech - Herbal therapeutic items �� specific direction will be given - OTC items 19

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NTA CTD execution Scope Applicable to a wide range of utilizations : - Full, new applications - Bibliographical applications - Abridged, Generic applications - Line-augmentations & Variations 20

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Regional (EU) particular Information – Module 1 Requirements for substance of EU application: * Directive 2001/83/EC – Art. 8-12 * Directive 2001/83/E C – Annex I Administrative and Scientific data * required by EU legislation give in * yet not reflected in CTD Module 1 21

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Module 1 of Volume 2B (NTA) 1.1 Overall Table of Contents (finish application; modules 1-5) 1.2 Application Form = current IA-frame 1.3 SPC , Labeling & Package Leaflet 1.4 Experts 1.5 Specific Requirements Annex Environmental Risk Assessment 22

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Module 1 .2 Application Form Complete modification by NTA amass , to reflect Principles concurred in Chapter 1 (Vol. 2A) * Legal premise * Annex II/Line-expansion Latest MS/EMEA prerequisites NEW improvements: Orphan Drugs, TSE, Scientific Advice, GMOs To be utilized as a part of current & new dossier arrange 23

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Module 1 .3 SPC/Labeling/PL * Based on EMEA/QRD Templates * National layouts may apply (for MR or national systems) In accordance with SPC and Readability rule Standard headings and sentences Available in 13 dialects (EMEA Web) * Mock-ups or Specimen of offers presentation 24

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Module 1 .4 Experts Art. 12 of Directive 2001/83/EC * specialists must give definite reports on the Q, S & E information * obligations of specialists Annex I to Directive 2001/83/EC SIGNED master reports « critical » assessment 25

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Module 1 .4 Experts Expert Reports Module 2 Overviews & Summaries Signatures Module 1.4 Info on experts Module 1.4 (training, background) 26

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Module 1 .5 Specific Requirements 1.5 Specific necessities for various sorts of applications 1. Data for bibliographical applications summary archive on legitimization for "well-set up use" guarantee 2 . Data for generics applications summary report on confirmation for "essential similitude" guarantee 27

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Well-settled utilize (bibliographical applications) Intended for "Old" items; no Essential Similarity Explain justification for utilizing productions ��  Literature to be incorporated into Module 4 or potentially 5 ��  Discussion in Module 2 (outlines and rundowns; incl. WEU claims) ��  Summary of WEU exhibition in Module 1.5 tending to every indent of Part 3I/4I of Annex I to Dir. 2001/83/EC 28

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Essential Similarity (bland applications) Module 1.5 : to contain outline archive on: Active substance (« same ») Overall S/E profile Bio-accessibility , Bio-identicalness Demonstrate « Essential Similarity » as characterized by the NTA (section 1) Case-by-case approval choice by powers 29

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Module 1 Annex ANNEX: Environmental Risk Assessment (Separate folio) Incl. Hazard Assessment Overview * Non GMO containing restorative items * Medicinal item containing/comprising of GMOs There is no ANNEX II ! (vagrant medications) 30

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Questions & Answers General CTD questions & Module 3-5 : IFPMA http://www.ich.org ctd-related.question@ifpma.org EU-particular Regulatory/Administrative inquiries Questions on Module 1 : EC http://pharmacos.eudra.org/F2/eudralex/vol-2/B/ctdqa_032003.pdf Aim to keep up orchestrated approach Shared, regular translation Refinement of direction ? 31

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EU Questions & Answers Q1 : Guidance on Mixed organization applications Q2 : Need to reformat "old" dossiers? Q3 : Reformatting = variety? Charge? Q4 : Format of Variation applications? Q5 : Mixed arrangements permitted after July 2003? Q6 : Format of Line Extensions? Q7 : Format of Generic applications? Q8 : Module 2 f

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