GCC (Gulf Cooperation Council) eCTD
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: GCC Module 1 Specification v1.2 and v1.5
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
- 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?
- Guarantee your ROI with an eCTD software that optimizes cost-per-submission
- 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.
For more information on the same, consult us
Other Countries
USA, EU, Health Canada, Switzerland, South Africa, Australia, EAEU, Jordan, Thailand, ASEAN
