Overview

eCTD (electronic Common Technical Document) is an electronic format that supports the submission of medicinal product applications, amendments, supplements and reports to the United States Food and Drug Administration (USFDA), European Medicines Agency (EMA) and other Health Authorities (HAs) worldwide. It also streamlines the submission process by facilitating the fast track creation and review of electronic data, lifecycle management, and the exchange of information. By enabling applicants integrate the metatags, hyperlinks and bookmarks to the data, it ensures efficient assessment and navigation of Regulatory information that leads to expedited HA reviews, and quicker market approvals/authorizations.

With a comprehensive knowledge of global Regulatory publishing trends and submission formats (for example, eCTD/Non-eCTD electronic submissions [NeeS]), Freyr supports dossier submissions across the globe. For efficient, effective and multi-country filings, Freyr offers data compilation, data publishing and dossier dispatches through an in-house Regulatory publishing and submission software, Freyr SUBMIT, that supports global HA submission formats. Adhering to the USFDA, ICH HL7 standards, Freyr is a strategic partner for multiple submissions within brief timelines, which has proven to be cost-effective for organizations.

The global eCTD formats, which Freyr can support are:

Health Authority by Country Application and Submission Type Submission Format Freyr Support


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), Briefing Book, eCTD baseline Submissions, Ad Promo Submissions, eCTD Submissions for lifecycle management (LCM) 

eCTD

Yes


European Medicinal Agency (EMA)

 

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 

 

eCTD

Yes


Health Canada

New Drug Submission (NDS), Supplement to a New Drug Submission (SNDS), Supplement to a New Drug Submission – Confirmatory (SNDS-C)

Abbreviated New Drug Submission (ANDS),

Supplement to Abbreviated New Drug Submission (SANDS)

eCTD

Yes


Swiss Medic

Initial submissions, Responses, Variations

eCTD

Yes


Saudi Food and Drug Administration

New Market Authorization (MA), Renewals of MA, Variation Type 1 and Type 2
Responses to Questions,

Periodic Safety Update Report (PSUR) submissions

eCTD

Yes


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

eCTD

Yes


Medicines Control Council (MCCZA) SOUTH  AFRICA

 

eCTD

Yes


Taiwan Food and Drug Administration (MOPH) THAILAND

Initials, Amendments

eCTD

Yes


Australian Therapeutic Goods Administration (TGA)

Market Authorization Application (MAA)

eCTD

Yes

 

The Chinese Food and Drug Administration (CFDA) has announced that eCTD will become mandatory within China by 2018. Life Sciences organizations who have not yet began preparing for the new CFDA Regulatory requirements are advised to act quickly for smooth transition. 

 

Freyr Expertise

  • Developing and maintaining the process of capturing and documenting the HA requirements
  • Paper to NeeS to eCTD conversions
  • Develop knowledge repository for regional requirements globally
  • Periodic training and updates on the ever-changing global Regulatory requirements
  • Gap analysis to create the process aids, charts
  • Continuous project monitoring
  • Periodic quality check for effective time management
  • Detailed tracker creation for all the version changes made through publishing lifecycle
  • Freyr SUBMIT – an in-house Regulatory publishing and submission tool
 

Freyr Advantages

  • A team of qualified publishing and submission experts
  • A robust publishing and submission software - Freyr SUBMIT
  • Submission roadmap right from compiling original submissions to maintaining lifecycle, to Regulatory resource allocation and support
  • Report level publishing, document-level publishing
  • Error-free submissions that enable your organization to focus on core business functions
  • Two-stage quality check process
  • 24x7 global delivery model
  • Transparent processes
  • Quick turnaround time (TAT)