On October 16, 2026, the 10th Yuncheng Tianyu·Drug Evaluation and Certification Technical Conference was held at the Lifeng Conference Center in Guangzhou. With the theme "New Order · New Ecosystem — Where Compliance and Value Coexist", the conference featured in-depth exchanges on drug developability thinking, the underlying logic of pharmaceutical international expansion, and regulatory compliance practices. Oracle Translation (Shenzhen) Co., Ltd. attended as a supporting organization of the conference, and Liu Yan, the company's eCTD Product Director, was invited to deliver a special report, systematically sharing the evolution of eCTD policies and enterprise implementation practices.

Theme backdrop of the 10th Yuncheng Tianyu · Drug Evaluation and Certification Technical Conference

Focusing on the New Order of the Industry: Discussing Full-Lifecycle Drug Compliance

The conference was guided by the Guangzhou Development District Science and Technology Innovation Bureau, the Guangzhou Huangpu District Science and Technology Bureau, and the Guangzhou Huangpu District Market Supervision Administration, hosted by the Guangdong Food and Drug Evaluation and Certification Technical Association, and organized by the Pharmaceutical Production Special Committee of the Guangdong Food and Drug Evaluation and Certification Technical Association.

Centering on three core topics — how quality systems move from compliance to international credibility, how manufacturing and registration capabilities support global expansion, and how post-marketing management forms a full-lifecycle closed loop — the conference featured a number of special reports on pharmaceutical going global, evaluation and inspection, R&D-to-production transformation, international registration, eCTD submission, pharmacovigilance, and supplementary applications, providing an exchange platform for drug regulatory, R&D, registration, production, quality, and third-party professional service institutions.

The conference in session

For pharmaceutical companies, internationalization means not only entering overseas markets with their products, but also the accurate transfer of technical documentation, the correct understanding of regulatory requirements, and full compliance in the structure, format, and method of submission dossiers. The conference's focus on going-global compliance and evaluation and certification topics is closely connected with Oracle Translation's dual-business model of "medical translation + eCTD".

Liu Yan Invited to Interpret eCTD Policies and Share Enterprise Implementation Practices

During the conference, Liu Yan, eCTD Product Director of Oracle Translation, delivered a special report titled "Streamlining the Full eCTD Submission Process: From Policy Requirements to Enterprise Implementation Practices". Liu Yan has more than ten years of hands-on eCTD submission experience and has long been involved in submission dossier processing, system application, and project delivery.

Liu Yan, Oracle Translation's eCTD Product Director, delivers a special report

As confirmed by the on-site presentation materials, the report reviewed the key policy milestones of China's eCTD implementation, the changes in submission scope, and the global progress of eCTD v4.0 implementation, and took the connection between policy requirements and actual enterprise operations as the main thread to explore how to translate regulatory requirements into specific steps such as dossier preparation, document processing, sequence compilation, validation, and submission.

The core value of the report lies in helping enterprises move from "understanding policies" to "building processes". eCTD submission is not simply the electronic conversion of documents, but a systematic requirement imposed on dossier quality, document standards, structural organization, technical validation, and cross-departmental collaboration. By interpreting policy milestones in combination with application practices, the report provided a reference for enterprises to identify key stages in submission preparation, improve internal coordination mechanisms, and enhance submission quality.

The report presents the key milestones of China's eCTD implementation

Medical Translation and eCTD in Synergy: Building a Service Closed Loop for Submission Dossiers

In the field of medical translation, Oracle Translation has long served professional directions including basic medicine, clinical medicine, pharmacy, biopharmaceuticals, medical devices, life sciences, food hygiene, and veterinary medicine, providing written translation, professional interpreting, multilingual localization, software localization, and website globalization services, and supporting multilingual needs in English, French, German, Japanese, Korean, and multiple Southeast Asian languages.

In the eCTD field, the company provides self-developed software products and submission outsourcing services, covering dossier preparation, writing and processing, publishing, validation, and submission, and provides corresponding technical support for major regulatory systems such as NMPA, FDA, and EMA.

The synergy of the two businesses enables Oracle Translation to organically connect professional language conversion, consistency of medical terminology, standardization of submission dossiers, and eCTD technical processing, forming a service closed loop from "multilingual dossier preparation" to "format compliance, technical validation, and regulatory submission", helping pharmaceutical companies respond in a more orderly manner to the language and technical compliance requirements in domestic and overseas registration submissions.

Oracle Translation's medical translation and eCTD service display area

In the future, Oracle Translation will continue to build on its medical language services and pharmaceutical regulatory submission technical practices, continuously refining its "language services + compliance technology" capabilities to provide professional, prudent, and efficient support for Chinese pharmaceutical companies entering the international market and for international medical products entering the Chinese market.