eCTD, eCTD 4, FDA, IDMP, Medical Devices

2019 FDA Goals: A Christmas Wish List

Image Credit Angie Chapman https://www.flickr.com/photos/angiet-cakefiend/7178335187/in/photolist-bWjQXM-5Nzjum-5Nvcrt-5MeAEL-2ixWd-5NvaLF-CZcM4n-7YXyHM-5eEVdZ-5eEVe6-VRZQJ5-97o4ku-FW4xX-64CNCY-X6HEUo-J3XeKS-5DgNxm-gBhhE5-X6HJ3N-7gZ4bC-5DgMhq-6khfTX-e9C6ZZ-5DcxDx-9HBaiw-nBqP7w-qBzhoK-hJYfj5-aoQA8J-iRdUdr-WTnycN-8UrP3g-7giMG1-XFeizH-8V8zy8-K6Azn-ZatFom-6z6eQG-8aNvz2-79G6Dg-XU8uhv-WntgLm-5LLfFN-SJLA7d-SKt1sH-K6kTf-QQfE51-Ujfch7-asm29b-ei5nx9

RAPS Regulatory Focus reported from the December 11, 2018 CMS/FDA Summit in Washington DC, as to Janet Woodcock’s goals for FDA in 2019. There was a focus on health, opioids, supply chain safety… all the stuff for which we all need the agency to excel, but I’m here for the changes in regulatory approval processes, of which there was very little:

The third top priority is the modernization of the Office of New Drugs (OND), which just hired a new director, Peter Stein, who was previously a deputy director. “Over the next year, we’ll be implementing many things we’ve been talking about,” Woodcock said, including regulatory automation tools and a multidisciplinary review template to reduce redundancies.

and

Looking into the long-term future, Woodcock also said the agency has to look at new ways for exchanging information with industry. The current system of electronic PDFs is not as advanced as it should be considering the current state of technology.

Interpreting the first of those two paragraphs as having impact on electronic submission processes is relatively optimistic, and the second is labeled “long-term.” Still, there are a number of things I would like to see FDA do over the next year, that aren’t too ambitious:

  • Start the eCTD Version 4 Pilot. This has been promised for a couple of years, and each February at the DIA RSIDM conference (where IQVIA will have some big announcements, by the way), FDA has said “the pilot will begin next year.”
    eCTD 4 is mostly evolutionary, not revolutionary in its capabilities, it’s still that “current system of electronic PDFs,” but it adds a major capability in two-way exchange using eCTD, and should make further changes a lot easier.
  • Set directions for the RPS standard for other divisions. The eCTD Version 4 standard is built on the HL7 RPS (Regulated Product Submissions) standard, which was designed to be flexible enough to support medical devices, food additives, tobacco, and cosmetics (I’ve joked that with some extensions to the common product model it could support review of iPhones by the FCC and aircraft carriers by military procurement). The real value of eCTD 4 won’t be realized by FDA until they have a submission standard and review tool that can be used across all their divisions.
  • Set directions for the IMDRF Table of Contents for Medical Devices. Just as the eCTD is just the electronic submission format for the Common Technical Document, the International Medical Device Regulators Forum (IMDRF) has developed the IMDRF ToC to cover all the necessary parts of a premarket notification or approval, as a superset of all the requirements of the major medical device market regulators. So far, Health Canada is the only country to announce support for it. FDA should step up and
  • Publish the FDA Use Cases for IDMP. IDMP was designed originally to provide common ways of assigning ID numbers for products so that they can be definitively identified for pharmacovigilance signal detection, but it’s morphed into many more things at EMA, including as a possible replacement for some of the simpler Variations that are filed due to minor manufacturing changes. FDA needs to declare what their use cases and operating model will be, so we can ensure maximum value in designing systems to manage both the US and European IDMP data. This fits closely with that last paragraph from Janet Woodcock.
  • Align PQ/CMC with IDMP. The initial draft of the PQ/CMC documentation had a lot of great ideas. It claimed to be compatible with IDMP, but only if you consider IDMP as a given, and “already there” before you start designing PQ/CMC. That original document had a lot of assumptions and unknowns, and making it an extension of IDMP’s data model will greatly help comprehension of its use.

Here’s to all our wishes coming true in the holiday season, and to a healthy and happy new year. Please contact us if we can make your last-minute regulatory shopping a little easier.

Image Credit Angie Chapman

Author: Joel Finkle

Joel became embroiled in electronic submissions when regulatory came downstairs and asked "Can we convert all our clinical study reports to WordPerfect format for the FDA reviewer?" and he didn't say, "No." Since then, he's been involved with custom CANDAs, PDF publishing, eCTD, document template automation, Regulatory Information Management, HL7's RPS, and the ISO IDMP standard. He joined ACUTA in April of 2017. He'd share some of his famous tomatillo salsa with you, but he can't carry it on airplanes.

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