eCTD Specification - Ministry of Public Health · Delivery of the eCTD Application • The Applicant will need to make an appointment through [email protected] and

©2014 Factorytalk Co., Ltd. • Proprietary and Confidential

eCTD Specification

11 December 2014

( 2 ) ©2014 Factorytalk Co., Ltd. • Proprietary and Confidential

• MES Projects in Japan, USA and Germany

• First South Asian projects

• Roll-out projects in USA and Australia

• HQ office relocation and regional GMP projects

• Open regional company in Singapore

• Start of the company in Bangkok, Thailand

• High growth in solutions business internationally

• First Projects in Thailand and China

• Regional Projects in Indonesia and Malaysia

• High Growth in compliance services regionally and wide range of solution projects

• Partnership for MES with Werum, Germany

• Factorytalk receives ISO certification

• Partnership for eQMS with MasterControl, US

• Partnership for eSubmissions with Lorenz, Germany

• Factorytalk received MasterControl Gold Partner Award

• Established ISPE Thailand affiliate

• HQ office expansion and new Regional and International Offices

2009 • First local MES and

eQMS Projects and office expansion

2010 2008 2013

2012 2011 2007 2005 2006 2004

2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 Today!

Factorytalk

Partners

Projects

>50 Clients

>20 Countries

>150,000 Man-hours


Supporting compliance..

Assessment

• GAP Analysis / Audits

• GMP Health-Check

Planning

• URS • Facility Design • Validation • Risk

Assessments • Training &

Workshops • CSV and IT

strategy

Implementation

• Project Management • Validation services • QMS remediation • Supplier Audits • Technology

Solutions: − ERP − MES − eQMS − LIMS/LES

− eSubmissions

Inspection

• Pre inspection readiness

• Mock inspections • Submissions

Management • Audit / Inspection

support

Optimization

• Post audit support • Overseas market

development and sourcing

• Productivity / process improvement

• Supplier sourcing

GMP standards


>2000yrs >1000yrs ~200yrs ~150yrs ~50yrs

~30yrs ~20yrs ~10yrs ~5yrs


Impact on access to information

• 80% of employees waste an average of half an hour per

day retrieving information

~ at Factorytalk this equates to 1.3M THB/yr

• 60% spend an hour or more duplicating work

~ at Factorytalk this equates to 2M THB/yr

Total = 3.3M THB

*Source: BAE Systems


ACTD

• ASEAN established the ASEAN Common Technical

Document (ACTD) to create harmonized

requirements and a common format for all

submissions of dossiers in the ASEAN countries.

• The ACTD is based on the European standard (CTD),

CTD format is required for the registration of all drug

products into EMEA regulated countries.

• Contents of Module 2 in CTD were separate in to

ACTD Part 2,3,4 as paper management during review

process is easier.

• TOCs aren’t required anymore in eCTD


eCTD

Module 1

Regional Admin

Information

Module 3

Quality

Module 4

Nonclinical Study Reports

Module 5

Clinical Study Reports

Quality Overall

Summary Nonclinical Summary

Nonclinical Overview

Clinical Summary

Clinical Overview

Module 2

NOT Part of the CTD

The CTD

ICH M4

ACTD Part 1

ACTD Part 2

ACTD Part 3

ACTD Part 4

A


Business Protocol

Prepare Submission

Application

eSubmission Identifier

Prepare the cover letter

and validation report

Delivery of the eCTD

Application at FDA (CD)

FDA : Feedback on Validation of Application

FDA : Start review process


Regional Content

• Module 1 administrative and prescribing

information

- The content and numbering of Module 1 for Thailand is

modelled after the EU Module 1 content as described in the

2008 version of the EU Notice to Applicants. Additional

documents specifically required by Thailand not covered by the

EU structure is describe in 1.A Additional Data of TH Module 1

and Regional Specification

• Modules 2 to 5

- No change from ICH eCTD Specification.

Prepare Application


Validation report

Delivery the application

Application feedback

Reviewing process


Handling of Empty or Missing eCTD Sections

• For new applications, including generic applications, detailed

statements justifying the absence of data or specific CTD

sections should be provided in the relevant Quality Overall

Summary and/or Nonclinical/Clinical Overviews e.g. Module 2.3,

2.4, or 2.5.

• For a generic application, there is no need to provide a

justification for content that is typically absent.

• Note that placeholder documents highlighting no relevant

content should not be placed in the eCTD structure.

Prepare Application


Validation report



Reviewing process


Bookmarks, TOCs, and Hyperlinks

• Bookmarks and/or TOCs make the review more efficient.

• The FDA recommends that documents with more than five pages and

with multiple sections should provide a Table of Contents, and/or if

appropriate, a Table of Tables, Table of Figures, etc. on the first page

of the document.

• Hyperlinks are recommended when they would aid the evaluation in

ways not already possible through the use of the eCTD index.xml and

document navigation aids.

• Applicants should consider when creating cross document hyperlinks

that they can cause confusion later in lifecycle and therefore be

distracting for an efficient review.

Prepare Application


Validation report



Reviewing process


File Reuse

• The FDA accepts and encourages applicants to make active use of file reuse.

• Applicants should not submit the same document multiple times.

• File reuse should be used when

- a file is submitted multiple times within one sequence,

- a file already submitted in an earlier sequence is being referenced again,

- or if a file submitted in another application is being referenced in a new application.

• Please note that the FDA is implementing a flat repository structure to make

cross application referencing possible.

- Links to content provided in other applications simply need to be directed out of the current

application structure and into the structure of the corresponding application.

- All application will be stored using the eSubmission Identifier to make cross referencing

easily predictable and possible.

Prepare Application


Validation report



Reviewing process


Structure

•Naming conventions for the

content files are irrelevant for

electronic review

•All content must be

referenced

by the appropriate XML files

for efficient navigation.

•Applicants should concentrate

on providing precise but

informative leaf titles to

aid reviewers.

Prepare

Application eSubmission

Identifier Validation

report Delivery the application


Reviewing process



• A request for an eSubmission identifier should made

via email. The request will require the following

information: - Licensee Number

- Description of Application.

- Dosage Form

- INN or Generic Name

- Strength

- WHO ATC Code

- Sequence Type

- Application form

- CPP (Optional)

Prepare Application


Validation report



Reviewing process



• The eSubmission Identifier will be issued

within 10 days of application. The Applicant

must check on the THAI FDA online service

for a response informing them of their

eSubmission Identifier. After receiving the

identifier, the Applicant must then make an

appointment for submission within 30 days.

Prepare Application


Validation report



Reviewing process


Validation Criteria

• No major new or unusual validation criteria

developed from EU eCTD V3.2

• Other regions were analysed, compared and adopted

if suitable

• Detail validation criteria can be found at TH Regional

Specification and Validation Criteria

Prepare

Application eSubmission

Identifier Validation

report Delivery the application


Reviewing process


Items worth noting

Validation Criteria

• Files and Folders - There are no naming conventions being validated

• ICH Backbone - File Reuse - Information is collected about references outside the

application and sequence as well as multiple references to a file within a sequence

• TH Regional - File Reuse

- Cover Letter must be New

- Information is collected when Application Form is not New

Prepare Application


Validation report



Reviewing process


Validation Tools

Most vendors offer free basic versions of their validation tools • No excuses for submitting applications that do not pass technical validation

• Make sure you validate on the media being submitted

• Validation should be limited to criteria specified by the FDA

- Some vendors provide extended profiles, these should not be provided with the

application

• List of validation tools will be provided on the eSubmission Website as

vendors provide evidence that they can sufficiently validate the FDA

requirements

• Current free version of validation tool being used by the FDA can be found at:

- http://www.lorenz.cc/esolutions/eValidator/ (Link also provided on FDA

eSubmission webpage)

Prepare Application


Validation report



Reviewing process


Business Protocol for Submitting

eCTD

Expected Structure of Submitted Media and Media

Formats • Expected structure of submitted media

- Content should be submitted in an application folder named after the eSubmission identifier.

- The sequence folder and its contents should be placed in this application folder.

- Large applications must be split and submitted on multiple items e.g. DVDs

- The overall folder structure should be included on each media so that content can be easily

merged

• Media formats

- The media formats acceptable when submitting an eCTD are:

o CD-R, DVD-RAM, DVD+R/-R,

- Ensure that you do not use:

o double-sided discs, rewritable discs or compressed or zipped files (except for validation

reports).

Prepare Application


Validation report



Reviewing process


Delivery of the eCTD Application

• The Applicant will need to make an appointment

through [email protected] and

deliver the application personally at the Division of

Policy System Development. The eCTD will be

validated and imported into the THAI FDA Review

System together with the applicant. Once accepted

and submitted, the applicant will be given back their

media to keep.

Prepare Application


Validation report



Reviewing process



• THAI FDA will inform applicants if there are

problems experienced during the upload of

an eCTD sequence.

• Confirmation of validation document will be

issue during appointment.

Prepare Application


Validation report



Reviewing process


Start Review Process

Initial Content Screening Process

Evaluation

Process

Administration Process

(include LoQ)

Issue Registration Certificate

Prepare Application


Validation report



Reviewing process


Technical Feedback

• 1 from 9 companies facing media failure

• 2 from 9 companies not passed validation

process of THAIFDA

• 2 from 9 companies have incomplete

Administrative information


Feedback from Pilot Group


Thank you! Teerapong Cheepchol

[email protected]

T: +662-630-4525

mailto:[email protected]



Documents

eCTD Specification - Ministry of Public Health · Delivery of the eCTD Application • The Applicant will need to make an appointment through [email protected] and