The National Medical Products Administration (NMPA) announced that starting March 1, 2026, China will allow the submission of electronic Common Technical Document (eCTD) format for clinical trial applications, marketing authorization applications, supplementary applications, re-registration applications for overseas-produced drugs, and generic drug consistency evaluation applications for chemical drugs, chemical active pharmaceutical ingredients (APIs), and biological products. The revised eCTD technical documents will be separately issued by the Center for Drug Evaluation (CDE) of the NMPA.

The National Medical Products Administration (NMPA) has clarified that starting from March 1, 2026, within one year, drug marketing authorization applications submitted via electronic Common Technical Data (eCTD) will be included in the priority acceptance service scope, with separate queuing and completion of acceptance review within 3 days, further enhancing the efficiency of drug registration review and approval.

Key Point! Pharmaceutical companies must not miss this policy dividend!

Within 3 days of acceptance, separate queuing, and accelerated review, eCTD submissions are directly granted a "green channel." However, many pharmaceutical companies are stuck on "not knowing how to proceed, not doing it well, or fearing mistakes" Don't panic! Our company's Drug Registration Department specializes in solving eCTD submission challenges for pharmaceutical companies, helping you fully benefit from this policy initiative Master the latest eCTD technical specifications and stay aligned with CDE requirements to avoid pitfalls. Whether it's chemical drugs, active pharmaceutical ingredients (APIs), or biologics, whether for clinical trial applications, marketing authorization, supplemental applications, or generic drug consistency evaluations, we provide precise matching and full compliance with regulatory requirements, eliminating the need for repeated document revisions or concerns about non-compliance.

Exclusive 1-year window period service, securing the 3-day expedited processing channel. Fully aware of the urgency for pharmaceutical companies to accelerate market entry! Our dedicated team will prioritize eCTD submission projects, assisting you in efficiently organizing electronic documents and standardizing formatting to meet the "separate queue" requirements. This maximizes the reduction of processing time, enabling faster drug approval and quicker profitability.

One-on-one support throughout the entire process, even for beginners. From data organization and digitization to application submission and progress tracking, dedicated personnel handle every step. No need to study complex technical specifications or assign dedicated staff, saving labor costs and allowing you to focus on core business.

With years of industry expertise and a proven track record of success, our team has dedicated years to the pharmaceutical registration field. We are well-versed in the entire eCTD submission process, having witnessed multiple updates to technical standards. Having served hundreds of pharmaceutical companies, we help clients successfully navigate various registration applications, avoiding all pitfalls in the submission process—reliable and hassle-free! More importantly, we prioritize high cost-effectiveness. We reject hidden fees, offering transparent and reasonable charges. Spend less and enjoy one-stop, high-quality submission services. Even small and medium-sized enterprises can collaborate seamlessly with us, outperforming competitors through cost-effectiveness!

Attention pharmaceutical companies: The eCTD submission window is only 1 year long. Act now to secure a first-mover advantage, receive acceptance results faster than competitors, and achieve drug market approval sooner!

Whether you are new to eCTD and unsure where to begin, have already attempted it but repeatedly rejected for revisions, or even wish to efficiently utilize the green channel to expedite the submission process—our team is the right choice for you!