What is eCTD?

eCTD (electronic Common Technical Document) is now the preferred method of submission to National Competent Authorities (NCA’s) and is becoming compulsory for European submissions, yet many pharmaceutical companies still fnd it challenging and costly to implement.

The Common Technical Document (CTD) describes the organisation of modules, sections and documents to be used by an Applicant for a Marketing Authorisation for a medicinal product for human use in each of the European Union, Japan and the United States (the three regions that are party to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for human

Use – ICH). The eCTD is defned as an interface for industry to agency transfer of regulatory information while at the same time taking into consideration the facilitation of the creation, review, lifecycle management and archival of the electronic submission (European Medicines Agency). eCTD is the electronic version of the Common Technical Document. It contains individual documents as PDF fles arranged in

a hierarchical folder structure reflecting that of the CTD. An ‘XML backbone’ links to each fle and provides descriptive information about the submission, the fles within it and their relationship to previous submissions. It allows you to see whether fles are “new”, have been “deleted” or “replaced”.

The Common Technical Document (CTD) describes the organisation of modules, sections and documents to be used by an Applicant for a Marketing Authorisation for a medicinal product for human use in each of the European Union, Japan and the United States (the three regions that are party to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for human Use – ICH).

The eCTD is defned as an interface for industry to agency transfer of regulatory information while at the same time taking into consideration the facilitation of the creation, review, lifecycle management and archival of the electronic submission (European Medicines Agency). eCTD is the electronic version of the Common Technical Document. It contains individual documents as PDF fles arranged in a hierarchical folder structure reflecting that of the CTD.

An ‘XML backbone’ links to each fle and provides descriptive information about the submission, the fles within it and their relationship to previous submissions. It allows you to see whether fles are “new”, have been “deleted” or “replaced”.

Regulatory requirements

eCTD is mandatory for all new marketing authorisation applications through the Centralised procedure, Decentralised procedure, Mutual Recognition procedure, Repeat Use procedures (RUP) and duplicates of new or previously submitted applications through the Decentralised or Mutual Recognition procedure. In July 2018 eCTD submission is mandatory for new marketing authorisation applications using National procedures, and in Q1 2019 eCTD mandatory for all submissions using National procedures.

With a comprehensive knowledge of global
Regulatory publishing trends and submission formats Marti Farm can support dossier submissions across the globe.

On 1st January 2010 the European Medicines Agency (EMA) made eCTD format compulsory for all Centralised procedure submissions. This was then rolled out to new Marketing Authorisation Applications (MAA) submitted
under the Decentralised procedure (DCP)

in 2015 and new MAAs under the Mutual Recognition procedure (MRP) in 2017. Ultimately all DCP and MRP submissions will need to be in eCTD format from 1st January 2018. The Heads of Medicines Agencies (HMA) eSubmission Roadmap includes an

implementation date of 1st July 2018 for compulsory use of eCTD for MAAs using National procedures (NP) and all regulatory submissions under NP by 1st January 2019.

On 1st January 2010 the European Medicines Agency (EMA) made eCTD format compulsory for all Centralised procedure submissions. This was then rolled out to new Marketing Authorisation Applications (MAA) submitted
under the Decentralised procedure (DCP) in 2015 and new MAAs under the Mutual Recognition procedure (MRP) in 2017.

Ultimately all DCP and MRP submissions will need to be in eCTD format from 1st January 2018.

The Heads of Medicines Agencies (HMA) eSubmission Roadmap includes an implementation date of 1st July 2018 for compulsory use of eCTD for MAAs using National procedures (NP) and all regulatory submissions under NP by 1st January 2019.

Why Use eCTD?

In addition to the fact eCTD is becoming mandatory for all EU procedures, in line with the HMA eSubmission Roadmap, there are many benefts associated with implementing the format for both industry and agencies.

The XML backbone allows agencies to automatically upload the sequence into their systems and hyper-linking allows for quick referencing of information. Since all fles are submitted electronically there is no need for agencies to scan documents or industry to print, transport and store masses of paper. Changes and updates to the dossier are easy for reviewers to identify, and, with electronic submission portals, can be presented to the authorities within minutes of completion,

drastically reducing processing time. With acceptance of eCTD growing worldwide it also facilitates a global submission strategy, reducing publishing time over several markets. A major advantage of eCTD is the product
lifecycle tracking element, being a central archive of all submissions. The current view and lifecycle features gives the viewer the ability to quickly and unambiguously determine what is currently registered for a particular product, as well as showing when and what changes

have been made during the eCTD lifetime. This facilitates easy version control and allows a whole company to access the documents simultaneously. By integrating the metatags, hyperlinks and bookmarks to the data, it also enables efcient assessment and navigation of Regulatory information that leads to faster reviews by HAs, thus enabling quicker market approvals/authorizations.

The XML backbone allows agencies to automatically upload the sequence into their systems and hyper-linking allows for quick referencing of information. Since all fles are submitted electronically there is no need for agencies to scan documents or industry to print, transport and store masses of paper. Changes and updates to the dossier are easy for reviewers to identify, and, with electronic submission portals, can be presented to the authorities within minutes of completion, drastically reducing processing time.

With acceptance of eCTD growing worldwide it also facilitates a global submission strategy, reducing publishing time over several markets. A major advantage of eCTD is the product lifecycle tracking element, being a central archive of all submissions. The current view and lifecycle features gives the viewer the ability to quickly and unambiguously determine what is currently registered for a particular product, as well as showing when and what changes have been made during the eCTD lifetime.

This facilitates easy version control and allows a whole company to access the documents simultaneously. By integrating the metatags, hyperlinks and bookmarks to the data, it also enables efcient assessment and navigation of Regulatory information that leads to faster reviews by HAs, thus enabling quicker market approvals/authorizations.

Be prepared for dossier e-submission!

  • Transition paper, NeeS or other e-format into eCTD
  • Prepare your medicinal product documentation for upcoming regulatory changes:
    • Document digitalisation
    • Rendering (generating images)
    • Document tags
    • Hyperlinks
    • Compliance with eCTD specifcations, e.g. PDF version, fle size, fonts, page numbering, review, protection etc.

Marti Farm expertise

  • Developing and maintaining the process of capturing and documenting the regional Health Authority (HA) requirements
  • Develop knowledge repository for regional and global requirements
  • Periodic training and updates on the ever-changing global Regulatory requirements
  • Gap analysis and creation of process aids, charts
  • Continuous project monitoring
  • Periodic quality check for effective time management
  • Detailed tracker creation to track all the version changes made through publishing lifecycle

Our comprehensive eCTD services include:

  • Project management of all regulatory submissions
  • Formatting and editing of regulatory documentation
  • Preparation of documents and references for submission
  • Verifcation and insertion of appropriate document hyperlinks
  • Initial submission of IND, NDA, ANDA, BLA, & Drug MasterFile (eDMF) submission and maintenance
  • Preparation and publishing of amendments and supplements
  • Communication with regulatory agencies
  • Country-specifc composition, publishing, and validation for submissions in the EU, USA and Japan
  • Utilization of our cloud-based software portal to ensure accurate and timely submissions
  • Document authoring and medical writing services

Over the past decade, flling in eCTD has become the mandatory or preferred method for numerous regulatory agencies for various submission types.
There are numerous benefts to creating and managing eCTD submissions:

  • Filing eCTD submissions reduces review times, leading to faster approvals
  • Electronic storage/search functions result in faster navigation within and between submissions
  • Going paperless saves on storage space and

reduces administrative burden

  • Improved ability to manage product lifecycle
  • Cost reductions associated with all of the above

Over the past decade, flling in eCTD has become the mandatory or preferred method for numerous regulatory agencies for various submission types.
There are numerous benefts to creating and managing eCTD submissions:

  • Filing eCTD submissions reduces review times, leading to faster approvals
  • Electronic storage/search functions result in faster navigation within and between submissions
  • Going paperless saves on storage space and reduces administrative burden
  • Improved ability to manage product lifecycle
  • Cost reductions associated with all of the above

We can support you with all of the eCTD formats there are, from EU to all over the globe:

 

Europe

European Medicinal Agency (EMA) – EU countries

  • Centralized Procedure (CP), Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), National Procedure (NP), Clinical Trial Application (CTA), Originals, Variations, AtoQs, Renewals, ASMF eCTD Submissions, Medical Device Submissions

Swiss Medic – Switzerland
Initial submissions, Responses, Variations

North America

Food and Drug Administration (FDA) – USA

  • Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biological License Application (BLA), Over the Counter (OTC), Drug Master Files (DMF Submissions), Structured Product Labeling (SPL) Submissions, supplemental new drug application (sNDA Submissions), Originals, Amendments, Annual report Submissions, Labeling Supplement Submissions, Periodic Adverse Drug Experience Report (PADERS), Briefng Book, eCTD baseline Submissions, Ad Promo Submissions, eCTD Submissions for lifecycle management (LCM)

Health Canada – Canada

  • New Drug Submission (NDS), Supplement to a New Drug Submission (SNDS), Supplement to a New Drug Submission – Confrmatory (SNDS-C)
  • Abbreviated New Drug Submission (ANDS)
  • Supplement to Abbreviated New Drug Submission (SANDS)

Australia

Australian Therapeutic Goods Administration (TGA)

  • Market Authorization Application (MAA)

Asia

Taiwan Food and Drug Administration (MOPH) – Thailand

  • Initials, Amendments

Middle East

Saudi Food and Drug Administration – Saudi Arabia

  • New Market Authorization (MA), Renewals of MA, Variation Type 1 and Type 2, Responses to Questions, Periodic Safety Update Report (PSUR) submissions

Ministry of Health (MOH) – Oman

  • New MA, Renewals of MA, Variation Type 1 and Type 2, Responses to Questions, Periodic Safety Update Report (PSUR) submissions

Africa

Medicines Control Council (MCCZA) – South Africa

Marti Farm will assist in:

  1. Supporting companies with regulatory compliance and periodic use of eCTD service
  2. Transitioning existing dossiers into eCTD format
  3. Secure and dependable infrastructure aimed to protect your intellectual property
  4. Support with new submissions
  5. eCTD support to consulting companies

To submit all needed documents in eCTD
format effectively and promptly in the EU
and globally, we invite you to

To submit all needed documents in eCTD
format effectively and promptly in the EU
and globally, we invite you to

Contact us

Headquarters

Lašćinska cesta 40
HR-10000 Zagreb
Croatia

Office

Planinska ulica 13/2
HR-10000 Zagreb
Croatia

Office: +385 1 5588 297
Pharmacovigilance: +385 1 5588 297
Clinical trials: +385 1 5614 330
Registration: +385 1 242 0873
Marketing: +385 1 2420 890
Fax: +385 1 2420 860
info@martifarm.com

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farmakovigilancija@martifarm.com
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Legal info

Full company name
Short company name
Headquarters
Office
Legal form
Court register
Registration number

Marti Farm Ltd. Trade and Services
Marti Farm Ltd.
Lašćinska cesta 40, HR-10000 Zagreb
Planinska ulica 13/2, HR-10000 Zagreb
a limited liability company
Commercial Court of Zagreb
080751121

 

OIB
Share capital
Authorized representative

29969122438
HRK 20,000.00 (paid in its entirety)
Martina Diminić Smetiško, director of the
company (Representing the company
individually and independently, Responsible
person for data protection)

 

Bank account

HR3623600001102197724 (Zagrebačka banka)
HR4324020061100628669 (Erste banka)

 

Full company name: Marti Farm Ltd. Trade and Services
Short company name: Marti Farm Ltd.
Headquarters: Lašćinska cesta 40, HR-10000 Zagreb
Office: Planinska ulica 13/2, HR-10000 Zagreb
Legal form: a limited liability company
Court register: Commercial Court of Zagreb
Registration number: 080751121

OIB: 29969122438
Share capital: HRK 20,000.00 (paid in its entirety)
Authorized representative: Martina Diminić Smetiško, director of the company (Representing the company individually and independently, Responsible person for data protection)

Bank account: HR3623600001102197724 (Zagrebačka banka), HR4324020061100628669 (Erste banka)

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