Starting from March 1, 2026, the National Medical Products Administration (NMPA) has officially expanded the implementation scope of the Electronic Common Technical Document (eCTD) for pharmaceuticals. Meanwhile, it has updated the relevant eCTD technical specifications and launched a number of preferential policies to support and encourage more enterprises to adopt the eCTD format for submitting drug registration application materials.
Amid the full promotion of eCTD, baseline submission, as a key link in the full implementation of eCTD, has become the focus of attention and discussion among industry colleagues due to the lack of referential practical submission cases, and has also caused confusion in the declaration work of many pharmaceutical companies.
Recently, Ms. Annie shared a practical case of domestic eCTD NDA baseline submission, detailing the entire submission process, core technical requirements and common issues, providing valuable practical references for the industry. Hereby, we sincerely thank Ms. Annie for her generous sharing. Combining with the case, we will comprehensively interpret the core points of eCTD NDA baseline submission to help you avoid declaration pitfalls and complete submissions efficiently.
Basic Concept: What is eCTD Baseline Submission?
First, we need to clarify the core definition of baseline submission:The eCTD Business Guide v1.1 clearly stipulates that a baseline refers to a registration act where an applicant converts clinical trial or marketing authorization documents that have been submitted and approved via non-eCTD formats into the eCTD submission format.
The baseline materials submitted by the applicant shall include at least all the latest approved and legally valid documents of Module 1, Module 2 and Module 3. In addition, a cover letter is required to confirm that the submitted application materials are completely consistent with the approved and valid registration documents, with only format conversion and no content modifications whatsoever.
The core purpose of baseline submission is to serve as the foundational basis for subsequent supplementary applications, variation applications and other relevant declaration activities, realizing the transition of marketed product document management to the eCTD submission format. It is not only the initial step of the full eCTD declaration process, but also a critical prerequisite connecting various subsequent declaration items.
In short, baseline materials serve as the "basic archive" for drug registration. All subsequent relevant declaration work will be based on these baseline materials, and their standardization directly determines the efficiency and success rate of future submissions.
FAQs: 4 Core Questions to Resolve All Confusions on Baseline Submission
Based on this practical case and Ms. Annie’s sharing, we have compiled the 4 core questions of greatest concern to pharmaceutical companies, with detailed explanations to help you quickly grasp key points and advance declaration work efficiently.
Q1: How should applicants conduct baseline submission?
A: Applicants may proactively initiate a baseline submission application to the regulatory authority according to their own declaration needs.The specific process is as follows: log in to the Applicant Portal, enter the NMPA Center for Drug Evaluation (CDE) Drug eCTD Registration System, complete the creation of original numbers, application for application numbers and sequence numbers in sequence under the eCTD Number Management module, and then launch the baseline submission process.
Tip: In practice, it is recommended to familiarize yourself with the operation logic of the Number Management module in advance, and accurately complete number creation and application to avoid disruptions to the document submission process caused by incorrect numbering.
Q2: What are the eCTD technical requirements for baseline materials?
A: The preparation of baseline materials must strictly comply with current eCTD technical standards and successfully pass eCTD technical validation. Cross-document linking is not mandatory.
Tip: The eCTD Business Guide v1.1 clearly states that bookmarks and hyperlinks are not required for baseline-type registration activities. Drawing on our experience in assisting baseline submissions in multiple overseas countries, enterprises may also appropriately set cross-document links based on their actual conditions to facilitate rapid document review by regulatory authorities during the product lifecycle management in the future.
Q3: What submission methods are available for baseline materials?
A: Baseline materials can be submitted either via DVD-ROM or through the eCTD Submission Gateway, both of which comply with relevant requirements.
Tip: Enterprises may choose the submission method according to their actual conditions. In the shared NDA baseline submission case, the enterprise selected submission via the eCTD Submission Gateway, which is more convenient and efficient, and suitable for enterprises with adequate network transmission conditions. For enterprises with limited network conditions, DVD-ROM submission is recommended to ensure stable document transmission.
Q4: Is an application form required for baseline submission?
A: No application form is required for baseline submission.
Tip: If submitting via the eCTD Submission Gateway, after logging in to the Applicant Portal and designating a transmission account, the system may prompt a mismatch between the selected transmission account and the account stated in the application form. In such cases, follow the system prompts to select the corresponding account as indicated for the application form and proceed with subsequent operations.
Summary: Baseline Submission Is Manageable with the Right Approach
With the full implementation of eCTD-related regulations, baseline submission will gradually become a routine operation for pharmaceutical drug registration and declaration. The sharing of this domestic eCTD baseline submission practical case has effectively broken the industry dilemma of "no available cases for reference", providing feasible operational guidance for pharmaceutical companies.
From Ms. Annie’s sharing and case review, it is clear that the core of baseline submission lies in following standards and mastering operations — by preparing materials in strict accordance with the latest eCTD technical specifications, becoming proficient in the operation procedures of regulatory systems, and avoiding common pitfalls in advance, baseline submission can be completed smoothly.
Our company has assisted applicants in successfully conducting baseline submissions in multiple countries. Based on past experience, baseline submission is not only a necessity for format conversion for applicants, but also a valuable opportunity to organize marketed product documents and lay a solid foundation for future compliant declarations.
We would like to express our gratitude again to Ms. Annie for her generous sharing of valuable practical experience for the industry. We will continue to monitor updates in eCTD policies and practical cases, providing more practical declaration guidance for pharmaceutical companies to help them complete eCTD submissions efficiently, seize policy dividends, and accelerate drug research, development and marketing.
