GCC eCTD (Gulf Cooperation Council)

Country: Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and United Arab Emirates
Health Authority: Gulf Central Committee/Saudi SFDA
eCTD, Accepted Since: December 2011
eCTD Version: Module 1 Specification v1.5, M2-M5 – v3.2.2 and M1-M5 – v4.0

Types of Applications

  • asmf: Active Substance Master File
  • extension: Extension Submission
  • new-bio: AA - Biological
  • new-gen: MAA - Generic (Multisource)
  • new-nce: MAA - New chemical Entity
  • new-rad: MAA - Radiopharmaceuticals
  • none: In the exceptional case 'None' must be stated. The submission unit will identify the sub-activity related to the product.
  • pmf: Plasma Master File
  • psur: Periodic Safety Update Report
  • psusa: PSUR Single Assessment Procedure
  • renewal: Renewal of Marketing Authorization
  • rmp: Risk Management Plan
  • transfer-ma: Transfer of Marketing Authorization
  • usr: Urgent Safety Restriction
  • var-type1: Variation Type 1
  • var-type2: Variation Type 2
  • withdrawal: Withdrawal

Process to be followed in making a GCC eCTD submission

  • Learn about the eCTD/Nees requirements
  • Review the eCTD/Nees submission guidance
  • Submit administrative forms and compliant PDFs
  • Request for the application number
  • Submit the eCTD submission via electronic media

How can Freyr help?

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  • Integration with inbuilt eCTD validator and PDF manager, submissions tracker and HA query management tool
  • eCTD software solutions and services from the secure certified cloud, pay-per-use model on usage volume with minimal investment.
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