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The eCTD is the electronic version of the modular Common Technical Document (CTD) system by the International Council of Harmonisation of Technical Requirements (ICH), which is mandatory for Applications for a Marketing Authorisation for medical products for human use within the European Union (EMA), Japan (MHLW), and which will start going into effect for new drug applications (NDAs) for the USA (FDA).
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 stones.
Duplicative animal and human testing are time- and cost-intense. Centralised standards on testing procedures and study evaluation will save you precious time and money, when wanting to expand your market.
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 your documents according to the specific regional regulatories.
Due to the implementation of the eCTD standards, reviewers were able to develop respective review standards, saving valuable time in bringing products to the market.
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 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 specialized in supporting and guiding our clients through this jungle of medicinal product approval and finding and following the right path to make his project a success.
For more detailed information and specific requests, please do not hesitate to contact us: