Glossary Term
eCTD (Electronic Common Technical Document)
Definition
The Electronic Common Technical Document (eCTD) is a standardized format for submitting regulatory information to health authorities such as the FDA, EMA, and other global regulatory bodies. It is used primarily in the pharmaceutical, biotechnology, and medical device industries to organize and submit documentation for regulatory approval. The eCTD allows for the electronic submission of documents required for marketing authorization applications, including clinical trial data, manufacturing information, labeling, and other required regulatory documents. The eCTD format is designed to streamline the submission process, facilitate easier updates and maintenance, and ensure compliance with international regulations for the approval and commercialization of medical products.
Relevance to the MedTech Industry
The eCTD is essential for submitting regulatory filings for medical devices, particularly during the approval process for new products or when making changes to existing products. The eCTD format enables manufacturers to efficiently manage and submit large volumes of data, including technical files, clinical studies, risk management documents, and post-market surveillance data, in a consistent and compliant manner. It ensures that regulatory submissions meet the specific requirements of global health authorities, helping to speed up the approval process and streamline communication between regulatory bodies and manufacturers. For MedTech companies, adopting eCTD is critical for achieving market access in multiple regions and maintaining regulatory compliance.
Additional Information & Related Terms
Related Terms
Regulatory Submissions: The process of submitting required documents and evidence to regulatory bodies to gain approval for the marketing and sale of medical products.
Clinical Trial Data: Data collected from clinical trials that supports the safety and efficacy claims of a medical device or drug, often included in eCTD submissions.
Medical Device Dossier: A comprehensive collection of documents submitted to regulatory bodies for the approval of medical devices, which may be submitted in eCTD format.
FDA 510(k) Submission: A premarket notification submitted to the FDA, often using the eCTD format, for devices that are substantially equivalent to an existing device.
EMA Submission: The process of submitting documentation to the European Medicines Agency for market approval of medical products, including the use of eCTD for electronic submission.