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How to Interpret the Latest FDA Guidance on Manufacturing Establishment Information and its Relationship to IDMP Standards
The draft guidance on manufacturing establishment information coordinates all of the information about an establishment and its associated business operations into one structured format. The draft guidance states, “Electronic submissions of manufacturing establishment information (MEI) must include complete information on the locations of all manufacturing sites, including packaging and control sites, for both drug substance and drug product.”
In December 2014, the US FDA published a binding guidance document, Guidance for Industry – Providing Regulatory Submissions in Electronic Format – Standardized Study Data, that establishes a requirement for submitting study data (clinical and non-clinical) in electronic format conforming to CDISC standards. After the publication of this guidance, all studies with a start date 24 months after the publication date (December 2014) must use the appropriate FDA-supported standards, formats, and terminologies specified in the Catalog for NDA, ANDA, and certain BLA submissions. Study data contained in certain IND submissions must use the specified formats for electronic submission in studies with a start date 36 months after the publication of this guidance.
These requirements pertain to submission of clinical and non-clinical data for studies initiated after December 17, 2016 if you’re filing NDAs, BLAs, and ANDAs. For commercial INDs, the requirement starts after December 17, 2017. In the event an original submission was filed before the requirements went into effect, subsequent submissions (amendments, supplements, and reports) to these types of applications still must meet the requirements.
On December 15, 2015, the International Conference on Harmonization (ICH) endorsed Step 4 of the eCTD v4.0 Implementation Package v1.0. Step 4 signals that major stakeholders agree on guidance. ICH released its implementation guide in early April 2016 and regulators in the US and EU followed suit. Industry is taking very real steps to implement eCTD v4. I’ve compiled a list of expectations on timing and impact for eCTD v4.
The evolution of the Electronic Common Technical Document (eCTD) has been a progression. More features and functionality become available to users as new versions are introduced. User adoption of eCTD also increases year over year. FDA Module 1 v2.3 (DTD 3.3) is a bridge to eCTD 4. A number of functionality enhancements set for inclusion in eCTD v4 first appeared in the new FDA M1 but were not present in FDA eCTD M1 (DTD 2.01). The shared features, presently implemented in FDA M1 v2.3 (DTD 3.3) and included in eCTD 4, are coded metadata, in the form of Controlled Vocabularies, and Grouped Submissions.
Foreign sponsors of drug applications who want to conduct business in the United States need an authorized U.S. Agent to interact with the FDA on their behalf. Expectations for the individual or company serving as the U.S. Agent should go beyond forwarding email and monitoring the fax machine. The U.S. Agent should add value in the form of regulatory insight and operational efficiency as you navigate the FDA apparatus.
In a notice posted to its website, Health Canada gave advance warning that the agency is considering an eCTD filing requirement, or eCTD mandate, that would take effect as early as January 1, 2018. Health Canada is asking for stakeholders to submit comments by August 31, 2016. Comments can be sent to firstname.lastname@example.org.
eCTD templates set the tone at the early stage of drug development for a smooth, standardized presentation of information in future regulatory submissions. Templates are favorable when compared to creating documents from scratch. Authoring templates make it easier to write summary documents and easily repurpose information from multiple reports without worrying about reformatting. High-quality documents are a precursor to successful submissions. Leveraging templates is one way to help make this possible.