Fundamentals of Electronic Submissions and eCTD TAKE Solutions Technology Analytics Knowledge Enterprise

Fundamentals of Electronic Submissions and eCTD Today's Presentation will be spreadover three main topics as below: Regulatory Guidance eCTD Technicalities Gap Analysis (in-house current regulatory operations vs recommended eCTD based regulatory operations)

Fundamentals of Electronic Submissions and eCTD Regulatory Guidance Some Definition Submissions Formats • Paper Full submission in Hard copy as printed Text • Electronic Submission in CTD folder structure in a CD /DVD with or without supporting Hard copies for legal or other requirements of the individual Agency • eCTD Submission of Documents with a Xml backbone sent eitherin a CD/DVD or uploaded in the agencys’ portal (the definitions can be with animation )

Fundamentals of Electronic Submissions and eCTD Regulatory Guidance Need For Regulatory Guidance The Constant changing Drug registration requirements is entering an Electronic Era The Scientists and Industry Experts require exposure on the current Electronic Documentation Practices This is the integration of Technical Knowledge, Regulatory Requirements and Information technology

Fundamentals of Electronic Submissions and eCTD Regulatory Guidance INTRODUCTION Regulatory guidance on legislation and regulations: Regulatory guidance such as laws, decrees, orders and any legislative and regulatory material related to pharmacy, drug manufacturing, drug registration process, commerce, information, promotion and advertising, e-trade is available ( this slide may not be required at this place)

Fundamentals of Electronic Submissions and eCTD Regulatory Guidance MAJOR AGENCIES IN REGULATED MARKET US: FOOD AND DRUG ADMINISTRATION (FDA) EU: EUROPEAN MEDICINES EVALUTION AGENCY (EMEA) EUROPEAN DIRECTORATE FOR QUALITY MEDICINES (EDQM) JAPAN: MINISTRY OF HEALTH ,LABOUR ANDWELFARE (MHLW) CANADA: HEALTH PRODUCT AND FOOD BRANCH (HEALTH CANADA)

Fundamentals of Electronic Submissions and eCTD Regulatory Guidance Web link to Drug regulatory sites: http://mednet2.who.int/mdra/pilotstudy_websites.htm (one of the various sites in the net giving lists of Drug regulatory Agencies world wide)

Fundamentals of Electronic Submissions and eCTD Regulatory Guidance Submission Types Investigational New Drug Application (IND) New Drug Application (NDA/ NDS) Abbreviated/Abridged New Drug Application (ANDA/ ANDS) Drug Master Files (DMF) Active Substance Master File (ASMF)

Fundamentals of Electronic Submissions and eCTD Regulatory Guidance Large no of documents + Different format for Different Agencies means More complication to Manufacturer Solution = Harmonisation of document ICH

Fundamentals of Electronic Submissions and eCTD Regulatory Guidance HISTORY & ROLE of ICH: ICH is – The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use in the year ---- First initiative to streamline the technical requirements for drug regulatory registrations A Joint effort of Regulatory authorities and industry association

Fundamentals of Electronic Submissions and eCTD Regulatory Guidance HISTORY & ROLE of ICH… continued Initiated by 6 Parties from European Union, Japan and USA -the EU, EFPIA, MHLW, JPMA, FDA and PhRMA. 3 Observers are WHO, EFTA, and Canada (represented by Health Canada) - acting as a link between the ICH and non-ICH countries and regions.

Fundamentals of Electronic Submissions and eCTD Regulatory Guidance HISTORY & ROLE of ICH… continued ICH Guidelines: The ICH Topics are divided into four major categories Q "Quality" Topics, - relating to chemical and pharmaceutical QualityAssurance. S "Safety" Topics, - relating to in vitro and in vivo pre-clinical studies. E "Efficacy" Topics, - relating to clinical studies in human subject. M "Multidisciplinary" Topics, - cross-cutting Topics which do not fit uniquely into one of the above categories.

Fundamentals of Electronic Submissions and eCTD Regulatory Guidance HISTORY & ROLE of ICH… continued M "Multidisciplinary" Topics, are grouped as M1: Medical Terminology (MedDRA) M2: Electronic Standards for Transmission of Regulatory Information (ESTRI) M3: Timing of Pre-clinical Studies in Relation to Clinical Trials M4: The Common Technical Document (CTD) M5: Data Elements and Standards for Drug Dictionaries

Fundamentals of Electronic Submissions and eCTD Regulatory Guidance

Fundamentals of Electronic Submissions and eCTD Regulatory Guidance

Fundamentals of Electronic Submissions and eCTD eCTD Technicalities

Fundamentals of Electronic Submissions and eCTD Gap Analysis

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