Skip to main content

Validation of eCTD Tools

BayBiotech.NET
Electronic Common Technical Document (eCTD) is an ICH standard adopted by FDA as a member of ICH, together with other member regions, Europe & Japan to facilitate electronic submissions to the agency. Harmonization of guidelines has been done to achieve global consistency in order to facilitate globalization of the drug discovery efforts. As of 2008, eCTD standard is the only acceptable format for new electronic submissions to the agency with an exceptions for submissions that are already under review. As the agency is working to standardize the eCTD process, it is encouraging the Industry to begin working on establishing a system for eCTD submissions. It is advisable to either use an in-house developed or commercially purchased e-CTD tool. In order to validate your eCTD tool, it will be important to pay attention to the following major issues identified by the agency regarding the eCTD submissions:

1. Lack of 356h, 1571, or 2252 forms in a submission.

2. Lack of .pdf Fillable Forms in a submission.

3. Usually more than one form in a submission is identified.

4. Mismatched, incorrect or missing application numbers.

6. Most of the eCTD submitted as eNDA.

7. More than one sequence included in one gateway submission.

8. One submission applied to more than one application.

9. Single file submission – Usually a single PDF file.

A validation plan to check for the abovementioned issues will help reduce the review time of a submission at the agency and will not cause a delay or return of your submission.

If you would like to read more on the eCTD submission, follow the link:
Electronic Regulatory Submission and Review (ERSR)

Comments

Post a Comment

Popular posts from this blog

FDA Launches Medical Device and Radiation-Emitting Product Transparency Web Site

BayBiotech.NET On April 19th, 2010 FDA launched he Center for Devices and Radiological Health (CDRH) Transparency Web site in support of the agency’s Transparency Initiative. The Web site makes available new information about CDRH’s decision-making processes and displays this information in a more user-friendly format. The site includes new information such as basic information about medical devices and how FDA regulates those products, information about medical devices before and after the products are on the market, in a searchable database, information about the clinical studies and trials conducted to demonstrate the safety and effectiveness of certain medical devices, memos from FDA employees explaining the reasons for the agency's decisions about medical device manufacturer requests to make a significant change in components, materials, design, specification, software, color additive, and labeling of a medical device as well as a step-by-step guide for manufacturers of...
1 comment
Read more

eCTD Submission Specifications

BayBiotech.NET The electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information. eCTD technical document format development was done by International Conference on Harmonization (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). Details on the specification for the ICH eCTD can be found in the guidance document M2 eCTD: Electronic Common Technical Document Specification. Currently, eCTD is the preferred format for electronic submissions by U.S. Food and Drug Administration. Although originally the CTD and the eCTD were designed for marketing applications, they could apply equally to other submission types, including INDs, master files, advertising material, and promotional labeling. In June 2008, FDA has issued guidelines for organizing the electronic regulatory document filing using the eCTD tools. This guidance discusses issues related to the electronic submission of applications for hum...
Post a Comment
Read more

Harmonization by Doing (HBD): Japan & U.S. Collaboration

BayBiotech.NET HBD is an international cooperative effort by Japan and US for regulatory convergence for Medical Devices. The efforts are focused on to develop global clinical trials and address regulatory barriers for timely device approvals. To address the needs for additional evaluation, the HBD initiative is a pilot project launched jointly by FDA and MHLW-PMDA for the premarket review of device cardiovascular technology. Instead of taking a theoretical approach to harmonization, HBD is focused on Proof of concept by utilizing parallel development, application submissions and review of actual medical device projects. HBD Study intends to collect and analyze regulatory submission data from multiple applications in the U.S. and Japan. The purpose of the study is to further understand differences that may exist with format and content, to define best practices and to improve globally harmonized processes. To read more about the HBD program, follow the link: http://www.fda.gov/M...
Post a Comment
Read more