Overview

The electronic Common Technical Document (eCTD) is an electronic format that supports the submission of applications, amendments, supplements, and reports to the United States Food and Drug Administration (USFDA), the European Medicines Agency (EMA), and other Health Authorities (HAs) worldwide. eCTD facilitates the quick creation and review of electronic data with the flexibility to integrate metatags, hyperlinks, and bookmarks into the data. The eCTD enables efficient assessment and effective lifecycle management of submissions for 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 multi-country filings, data compilation, data publishing, and dossier dispatches. For faster, compliant, and seamless submissions, Freyr offers an in-house eCTD publishing and submissions management software, Freyr SUBMIT PRO, that adheres to the regional and ICH standards.

The global eCTD submissions formats, which Freyr can support are:

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

Food and Drug Administration (FDA) USA
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, and 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, and eCTD Submissions for Lifecycle Management (LCM)

eCTD

Yes

European Medicinal Agency (EMA)
European Medicinal Agency (EMA)

 

Centralized Procedure (CP), Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), and National Procedure (NP)

Clinical Trial Application (CTA), Originals, Variations, AtoQs, Renewals, ASMF eCTD Submissions, and Medical Device Submissions

 

eCTD

Yes

Health Canada
Health Canada

New Drug Submission (NDS), Supplement to a New Drug Submission (SNDS), and 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
Swiss Medic

Initial submissions, Responses, and Variations

eCTD

Yes

Saudi Food and Drug Administration
Saudi Food and Drug Administration

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

Periodic Safety Update Report (PSUR) Submissions

eCTD

Yes

Ministry of Health (MOH) - Oman
Ministry of Health (MOH) - Oman

New MA, Renewals of MA and Variation, and Type 1 & Type 2 Responses to Questions

Periodic Safety Update Report (PSUR) Submissions

eCTD

Yes

sahpra
[formerly known as MCC]

 

eCTD

Yes

Thailand Food and Drug Administration
Thailand Food and Drug Administration

Initials and Amendments

eCTD

Yes

Australian Therapeutic Goods Administration (TGA)
Australian Therapeutic Goods Administration (TGA)

Market Authorization Application (MAA)

eCTD

Yes

Jordan Food and Drug Administration (JFDA)
Jordan Food and Drug Administration (JFDA)

Baseline Submissions and Initial Market Authorization
(JO eCTD Module 1)

eCTD

Yes

National Medical Products Administation (NMPA)

Baseline Submissions, New Drug Applications, Generic Drug Application, and Clinical Trial Application (Module 2 to Module 5)

eCTD

Yes

The National Medical Products Administration (NMPA) [formerly the CFDA] has announced that the eCTD submission format will soon become mandatory and will be in force from the first quarter of 2019. Life Sciences organizations that have not yet begun adopting the new NMPA eCTD Regulatory requirements are advised to act quickly for a smooth transition.

 

Freyr Expertise

  • Developing and maintaining the process of capturing and documenting the regional Health Authority (HA) requirements
  • Paper to Non-eCTD electronic submissions (NeeS) to eCTD conversions
  • Develop a knowledge repository for regional requirements across the globe
  • Periodic training and updates on the ever-changing global Regulatory requirements
  • Gap analysis to create the process aids, charts, etc.
  • Continuous project monitoring
  • Periodic quality check for effective time management
  • Detailed tracker creation to track all the version changes made through the publishing lifecycle
  • Freyr SUBMIT PRO – an in-house Regulatory publishing & submissions eCTD tool
 

Freyr Advantages

  • A team of qualified publishing and submission experts
  • A robust eCTD publishing and submissions software
  • eCTD submission roadmap right from compiling original submissions to maintaining lifecycle
  • Regulatory resource allocation support
  • Report-level publishing and 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)
 

Freyr SUBMIT PRO

For faster, compliant and seamless submissions, Freyr offers an in-house eCTD tool Freyr SUBMIT PRO. Freyr SUBMIT PRO suits all your submission requirements across the globe and supports regional formats. To know more about Freyr SUBMIT PRO, gain a comprehensive overview at:

www.ectdtool.com