GULF COOPERATION COUNCIL (GCC) Regulatory Services

Gulf Cooperation Council countries (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and the United Arab Emirates) have implemented eCTD format for submissions as per the following schedule:

• Saudi Arabia (July 17th, 2016)
• United Arab Emirates (October 1st, 2017)
• Oman (January 1st, 2015)
• Bahrain (November 1st, 2016)
• Qatar (optional as of September 1st, 2019, and mandatory starting September 1st, 2020)

GCC countries follow the GCC eCTD specifications, common for the entire region. This includes a specific Module 1.

Asphalion ensures that eCTD submission will always follow the most updated Module 1 specifications and validation rules (current Module 1 version for GCC Countries is v1.5).

When needed or required, Asphalion can give you support on preparing physical media to be exchanged with the Regulatory Authorities (CD/DVD or paper copies).

Contact us for more information.