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The eCTD is the electronic version of the modular Common Technical Document (CTD) system established by the International Council of Harmonisation of Technical Requirements (ICH), which is mandatory for applications for a Marketing Authorisation of medical products for human use within the European Union (EMA), and Japan (MHLW. As of 2017, FDA only accepts New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs) using eCTD format. Commercial Investigational New Drug Applications (INDs) and Master Files are also now required to use eCTD format (2018).
A vital resource intensive part of the introduction of medicinal products to either your national or the international market is following and fulfilling respective standards and guidelines for the submission of applications, amendments, supplements, and reports. By implementing the eCTD, the ICH sought to reduce unnecessary stumbling blocks.
Avoid Duplicative Testing
Duplicative animal and human testing are time- and cost-intensive. Centralised standards on testing procedures and study evaluation will save you precious time and money when wanting to expand your market.
Simultaneous Submission
eCTD submission enables you to file for approval of your medicinal product in three different regions at the same time - Europe, Japan, USA - without having to adjust all of your documents according to the specific regional regulatories.
Reviewer Efficiency
Due to the implementation of the eCTD standards, reviewers were able to develop respective review standards, saving valuable time in introducing products to the market.
Faster Market Access
Overall, the avoidance of duplicate testing, the possibility of simultaneous submission, and the boost in reviewer efficiency lead to a faster product availability within the health science industry, thus leading to an increased chance of your product`s success.
Throughout the past several years, IASON consulting has witnessed a lot of changes within the health science industry, including the implementation and enforcement of standardised documentation and application. Our consultants are specialised in supporting and guiding our clients through this jungle of complex medicinal product approval, and finding and following the right path to make the project a success.
Should you require our assistance in producing eCTDs, please do not hesitate to contact us.