ANVISA Signs e-CTD Contract: Promoting International Harmonization and Information Exchange in Drug Regulation
Notícias Anvisa, em 01.10.2025 | Artigos e Notícias - Editora
Summary
Brazil's ANVISA signed a contract for the electronic Common Technical Document (e-CTD). This enables drug applications using formats utilized by major global regulatory agencies, which is expected to accelerate technical analysis.
Details
ANVISA recently signed a contract for the e-CTD (electronic Common Technical Document). The e-CTD serves as an international standard and is used by major pharmaceutical regulatory authorities worldwide. This tool allows drug process submissions in the format utilized by leading global regulatory agencies. This is considered a priority for the pharmaceutical sector and is crucial for streamlining technical analyses. The adoption of e-CTD, alongside other international standards like IDMP (Identification of Medicinal Products) and HL7 FHIR (Fast Healthcare Interoperability Resources), ensures interoperability and efficient information exchange between healthcare systems and regulatory authorities across different countries. It also enables data-driven technical analysis, leading to greater speed and equity. The CTD itself (Common Technical Document) was developed by the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). Its goal is to harmonize the format of submissions for new drugs in major countries like the US, EU, and Japan, simplifying review and approval processes. e-CTD digitizes this process, allowing not only similar content and order but also a more organized and systematic electronic submission. Furthermore, recent versions of e-CTD facilitate the simultaneous submission of structured data with documents. This helps build a more robust database for decision-making regarding registration and facilitates easier sharing among different regulatory agencies. Consequently, it simplifies the application of optimized analysis procedures like 'reliance' (analysis by utilization) and joint evaluations ('worksharing'), accelerating product availability to patients. ANVISA also announced a webinar concerning the ICH Q3E Guideline for Degradants, soliciting contributions from society. This effort is part of aligning international regulatory guidelines to ensure higher safety and predictability in pharmaceutical development.
Technology Note
FHIR（Fast Healthcare Interoperability Resources）は医療データ交換の国際標準。このエントリの関連技術: FHIR
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