EBOPS

EBOPS is an acronym that commonly refers to the Electronic Common Technical Document (eCTD) Business Object (BO) Specification. This specification defines the structure and content for the electronic submission of regulatory information to health authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The eCTD system is a standardized format that allows pharmaceutical companies and other regulated entities to submit comprehensive dossiers of data and information in a secure and efficient manner.

The EBOPS specification is crucial for ensuring that regulatory submissions are consistent, well-organized, and easily reviewable by health authorities. It defines the various components of a submission, including technical documents, study reports, and administrative information, and dictates how these components should be structured and linked. This standardization facilitates the digital exchange of information, improving the efficiency of the regulatory review process and ultimately contributing to faster access to safe and effective medical products for patients. The adoption of EBOPS is a key aspect of the global move towards electronic regulatory submissions.