As the electronic Common Technical Document (eCTD) became the standard for submitting Regulatory Information to leading agencies worldwide, its adoption still poses a considerable challenge for those agencies who lack the needed human and/or material resources. How is the situation in the Middle East and North Africa (MENA) region and what other dossier formats are accepted there?
eCTD in MENA region
The implementation of the ICH’s Common Technical Document (CTD) by several countries in the MENA region became one of the major recent developments in the management of regulatory dossiers in the area. The ultimate objective was moving from the paper-based, non-CTD submissions of the regulatory dossier to the CTD/eCTD based formats which would facilitate the review of the dossier and tracking of the regulatory information by the Health Authorities (HA).
Some agencies in this region have already successfully implemented the eCTD specification. Thus, what follows is an overview of the eCTD implementation status in the MENA region with information on required alternative dossier formats.
Following countries in the MENA region have implemented the eCTD format:
- Saudi Arabia (on July 17th, 2016)
- United Arab Emirates (on October 1st, 2017)
- Oman (on January 1st, 2015)
- Bahrain (on November 1st, 2016)
- Qatar (optional as of September 1st, 2019, and mandatory starting September 1st, 2020)
- Jordan (on 1st January 1st, 2019, with a pilot phase between the January 1st, 2019, and the March 1st, 2019)
Saudi Arabia and Gulf Cooperation Council (GCC) countries follow the GCC eCTD specifications that are common for the region including a specific Module 1.
eCTD vs. CTD
The eCTD has the same structure of the CTD which includes the following modules:
- Module 1: Region Specific or Administrative Module that would change from one country to the other especially in terms of the application forms, pricing certificates content, packaging and labeling information, declaration letters, g., patent letter.
- Module 2: Summary of Modules 3, 4 and 5
- Module 3: Quality Part, including but not limited to: Drug Substance (3.2.S) and Drug Product (3.2.P) where information about the specifications, stability, analytical methods, manufacturing process, and other quality related sections of the dossier can be found
- Module 4: Non-clinical studies
- Module 5: Clinical studies
The eCTD is an electronic version of the CTD. This does not mean that it is a soft copy of the CTD. The eCTD is published using specific IT programs that create the XML backbone, envelope and granularity of the documents within each Module. The user of the software will upload the sections of the regular CTD in order to create the eCTD. Before the software publishes the eCTD, it will pass the uploaded information through the validation phase according to the validation criteria set by the HA.
The specification for the eCTD is based upon content defined within the CTD. The CTD describes the organization of modules, sections and documents. The structure and level of detail specified in the CTD have been used as the basis for defining the eCTD structure and content but, where appropriate, additional details have been developed within the eCTD specification.
The main advantage of the eCTD is that it creates a lifecycle for the registration dossier starting with a sequence (0000). Any query issued by the HA shall be answered by the pharmaceutical company also via eCTD and it will be published in a sequence (0001). The same applies for the forthcoming regulatory activities (renewals, variations, response to inquiries).
Each module has a Table of Content (TOC) which includes all the sections with hyperlinks, i.e., that can take the user directly to the desired section in a click. The entire eCTD as well has a table of content listing the modules with hyperlinks that can take the user to any Module with simply a mouse click.
In addition to the lifecycle management, there are many other advantages brought by the implementation of eCTD to both the Health Authority and the Industry:
From the HA perspective:
- State of the art format of the registration dossier aligned with international standards
- Easy navigation and review of the dossier resulting in faster review times
- Reduction of physical paper flow and physical archive
- Easy creation of assessment reports
- Easier access to the current status of documentation
- Electronic access to the whole lifecycle of a product
- Simultaneous access to the dossiers/documents by several reviewers or departments at the HA
From the Industry Perspective:
- Reduction of printing and shipping costs
- Easy retrieval of submitted documents
- Streamlining of processes (facilitates interdepartmental work)
- Easier submission lifecycle management
- Higher capabilities for comparing dossiers submitted in different markets
- Reduced time to market (because eCTD will facilitate and shorten health authority review time of the dossier)
- Adopting worldwide standard of submissions
Other countries in the MENA region have implemented the CTD format only, which will be considered sufficient for the submission of the registration dossier, according to the local regulatory requirements.
Countries that implemented only the CTD format are the following:
|Algeria||Algerian ANPP updated the checklist of requirements of the “Fiche De Recevabilité Des Dossiers D’enregistrement Version 00” issued on February 20th, 2017, to request the technical dossier in CTD format (Module 2, 3, 4, and 5). The checklist was further updated on January 15th, 2018, to Version 01 while maintaining the requirement for the technical dossier in CTD format.|
|Egypt||According to decree 820/2016 implemented starting January 2017, products should be submitted in CTD based format to benefit from registration within a period that does not exceed 6 months. However, if the product is submitted through CTD and is FDA and/or EMA approved, it will be registered in 1 to 2 months.|
|Iraq||Iraq HA accepts registration dossier in CTD format, but it is not mandatory at the moment.|
|Kuwait||CTD implementation is following ICH requirements and was reinforced by local ministerial decision number 361/2019 issued on December 26th, 2019.|
|Lebanon||CTD implementation is mandatory for imported products for sections 3.2.S and 3.2.P according to the Ministry of Health (MOH) memo number 8 issued on January 16th, 2012. However, there is flexibility in the implementation of CTD format for locally manufactured products, i.e., it is optional for the time being.|
|Morocco||According to circular number 15DMP/00 issued on February 23rd, 2016, CTD becomes mandatorily implemented in Morocco.|
|Tunisia||According to the updated registration guide issued on February 17th, 2016, the technical dossier should be submitted in CTD format with an implementation date starting on May 1st, 2016.|
The eCTD has become an important regulatory requirement in major MENA markets. The remaining countries in the region are expected, sooner or later, to adopt it too.
Therefore, pharmaceutical companies selling or planning to sell to this region should clarify and meet the existing dossier requirements – especially those related to Module 1: Regional Information.
The eCTD region-specific dossier is a prerequisite for market access in the abovementioned MENA countries. It is not only mandatory for the initial registration/approval but also is a key requirement for product maintenance activities since the eCTD requirement is being implemented for Renewals and Variations as well.