NEW Deadline: May 5th, 2018 (updated as of April 2017)
In 2015 the FDA announced that all submissions of Drug Master Files (DMF) to the FDA via the Electronic Submission Gateway must be in eCTD format. This guidance is stricter than the recently issued guideline of the European Directorate for the Quality of Medicines and HealthCare (EDQM) regarding electronic submissions of CEPs.
What does this mean for you as a DMF holder?
Starting on May 5th 2018, FDA requires all new Drug Master Files as well as all documents submitted to existing DMFs, to be submitted in an electronic format. In this matter the FDA has published eCTD guidance that applies to all DMF submissions. The Electronic Common Technical Document (eCTD) is the standard method for submitting to FDA. This includes Drug Master Files (DMFs), Biological Product Files (BPFs) and other master files. If the submission does not occur in eCTD format after the 5th of May 2018, FDA will reject it. There will be no waivers or exemptions.
PharmaLex is the perfect partner to support you. We are capable of preparing submissions of DMFs and BPFs in line with the FDA regulation. By analyzing your existing files and evaluating pre-submission considerations we place great value on the effective and efficient transition of your DMFs to eCTD format. This includes the close alignment with eCTD requirements in the EU and world-wide for broad re-use of eCTD submissions.
Our experts are continuously updating their skills and knowledge to provide the best understanding, interpretation and utilization of regulatory guidance and regulations. We are up-to-date on industry and government agency best practices and trends.
We provide extensive due diligence, anticipating what an assessor will need or require. Our team provides the complete quality dossiers that contain all necessary documents including CTD Module 3 and 2.3, IMPD, IND, ASMF/DMF, CEP.
Defining an overall eSubmission roadmap (CMC)
Over the years our experts have specialized in aligning with eCTD requirements in the EU as well as globally in order to guarantee a broad re-use of eCTD submissions. During the process we focus on the gap analysis of relevant approved and updated documents before converting existing paper DMFs into eCTD format. We set up a submission structure allowing us a granularity of files and folders. Furthermore, we implement file formats and versions that allow us a detailed tracking of updates to ensure an efficient document lifecycle and transmit the final electronic submissions using appropriate gateways and portals. In order to optimize the global submission process, we define an overall eSubmission roadmap.
Our experts are members of various eCTD and related working groups across the industry, acting as well-known speakers and session-chairs on international eCTD- and Regulatory Operations-related conferences and seminars.
Want to know more? Here are just a few eSubmission services we provide:
- Country-specific eCTD compilation, publishing and validation for submissions in Europe, the USA, Switzerland, Gulf Region (GCC), Canada and many more.
- Fully electronic submissions via CESP, EMA gateway and FDA ESG
- Regionally adapted PDF publishing for RoW submissions and non-eCTD based submissions
- Supporting you with the switch to eCTD
- XEVMPD and IDMP implementation
- Consultancy services for submission process optimization, Regulatory Operational Excellence and effective Regulatory Information Management