Before the final release of the supporting documents for the “Measures for the administration of drug registration”, the China NMPA has issued the following drafts for public consultation:
In January, Health Canada notified industry of their plans and timelines to start transitioning product monograph templates into a structured format based on XML, HL7 Structured Product Label (SPL) standard and controlled vocabularies.
LORENZ has implemented a publishing module for EAEU submissions in docuBridge based on the EECB No. 79 specifications and the R.022 schema. Interested customers can connect to LORENZ Cloud for an early glimpse on how to publish EAEU submissions. Please contact your Account Manager for further information. The publishing module will be continually updated to reflect any further specification changes. The EAEU submission publishing will soon be commercially available as a normal docuBridge publishing module. Continue reading
On September 17, 2019, the official website of the CDE of the Chinese NMPA began soliciting public opinions on the preliminary draft of eCTD submission guidelines, the supporting eCTD technical specifications, verification standards and other related documents. The deadline for submitting opinions is October 17, 2019. Please provide your feedback before this closing date.
Previously, the draft eCTD specifications and validation criteria had been issued for advice in March 2019. This second round of public consultation signals that China is now in the final stage of eCTD preparation, and that the eCTD pilot phase will soon be launched. This means that companies should be fully prepared to implement eCTD submissions, and possibly willing to participate in the pilot.
For the original notification from CDE, please click here.
In November 2018, we released a press release regarding the Chinese NMPA, noting that the agency selected our docuBridge and eValidator solution as an eCTD data management system. Now, the next step has been taken towards introducing eCTD submissions in China.
The CDE of the NMPA published the Chinese eCTD specification on March 1, 2019. Comments are appreciated until April 1, 2019. This marks an important milestone in China´s eCTD project, beginning the countdown to the final implementation of eCTD submissions in China.
Because of our involvement in this project, we can offer our customers around the world a head start in meeting China´s new eCTD submissions requirements. Please feel free to contact us or ERIS, our distributor for LORENZ e-regulatory affairs solutions in mainland China, regarding inquiries and further collaboration.
In response to questions about our ongoing implementation project at the US FDA, we would like to share a short update with you.
In our previous blogpost, we announced the need to migrate approximately 1.3 million legacy eCTD sequences into our docuBridge solution and make them available to US FDA reviewers.
The LORENZ implementation team was on-site at the USFDA headquarters in Silver Spring, Maryland between April 30 and May 4, 2018, to discuss the implementation process and to begin the training of agency personnel in LORENZ solutions within its RIM portfolio.