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The changing landscape of the life sciences industry makes it necessary for the companies to adapt to the global Regulatory requirements, immediately. Companies need to evolve themselves for the necessary transition with each mandatory requirement from the health authorities. One such mandatory requirement in recent times is the Electronic Common Technical Document (eCTD) format, an electronic equivalent to the Common Technical Document (CTD) format.
The purpose of introducing the eCTD was to reduce the burden on the reviewers of the health authorities and to simplify the process of submission as some of the key Regulatory authorities have already consigned to use it as a standard format for submissions. To ensure all the applicants practice the same, there are certain mandatory deadlines imposed by global health authorities. Though many of the deadlines for eCTD adoption have already passed, there are many in the pipeline to be adhered to. As an end-to-end Regulatory partner, aiming at successful compliance at every step, here we bring you a list of mandatory eCTD requirements that are still active and need to be complied with by Jan 1, 2020.
Health Canada
In 2014, Health Canada had published a guidance document on the preparation of drug Regulatory activities in eCTD format. It also started accepting individual requests for exemptions for those unable to use the eCTD format for Regulatory activities, with appropriate justification. However, as of Sep 13, 2019, Health Canada summarized the mandatory eCTD format requirements for Regulatory activities already implemented or effective at a future date.
In its recent notice, Health Canada has made eCTD format mandatory for Master File Submissions with a deadline of Jan 1, 2020. New submissions can be made in the current “non-eCTD electronic-only” until this date. However, once a Master File has been filed in eCTD format, all additional filings must also be filed in the eCTD format.
EDQM
The European Directorate for the Quality of Medicines (EDQM) has been updating the guidance for preparing and submitting eSubmissions.
As per the recent EDQM roadmap, all CEP applications will have to be submitted in eCTD from Jan 1, 2020, failing to which, the EDQM will stop accepting Non-eCTD electronic Submissions (NeeS) for notifications, revisions and renewal applications.
HALMED
Agency for Medicinal Products and Medical Devices of Croatia (HALMED), has committed to implement a common European strategy for the introduction of electronic filing requirements in Regulatory procedures for medicines.
As per its recent update, HALMED provided a deadline of Jan 1, 2020, to ensure that all Regulatory submissions should be filed in eCTD format.
With region-specific submission formats and compliance timelines becoming crucial for global market-entry, companies need to opt for a smart eCTD publishing software to smoothen their eCTD submissions. All we can say is that the transition phase for eCTD has already begun. It is time that the companies need to adapt to make submissions easier for the health authority reviews. Submit the eCTD way.
