2021 年 8 月 31 日

Increased Regulatory Demands for Structured Content Data Submission

With the imminent introduction of IDMP[i] in the EU[ii], there will be a significant expansion in requirements to report structured data; XEVMPD[iii], SPL[iv] and eAF[v] ‒ were some of the first examples of standards that mandate structured data submissions using agency-defined controlled vocabularies.

Benefits of Standardization

The benefits of these standards are clear:

  • Aligned definition of products
  • Increased patient safety through more robust pharmacovigilance
  • Far better visibility into product supply
  • Provision of product labeling content both electronically and in a human-readable format
  • Simplification of the exchange of information across regulatory agencies
  • Data-compliant RIM systems

Ultimately, what does this mean? Reduced risk of supply shortages for key medicines, complete traceability from manufacture to patient, and early identification of safety . With and EMA[ii] paving the way, the rest of the world will soon be following suit.

“It is abundantly clear that future health authority requirements will focus on structured data reporting and this is a key area where life sciences and vendors need to focus their attention.”

– 凯理斯 RIM 总监 Karen Harry

In the ‘Regulatory Agency Delivery Plan 2021-2023′ released in July 2021, the UK[i] MHRA[ii] committed to “…Improve our ability to capture and exchange data with partners by adopting international standards including ‘Identification of Medicinal Products’ regulations by Q2, 2022/23.”

Impacts for Industry and Vendors

Life sciences and medical device companies, as well as vendors, will need to move swiftly and with agility to ensure processes, systems, APIs[iii], and requirements for controlled vocabulary mappings are in place to sustain these increasingly complex requirements.

Independent of Health Authority requirements, it will be advantageous for life sciences companies to capitalize on IDMP requirements; to build global data governance, increase reporting capabilities, and make better-informed decisions in support of product commercialization and strategies for lifecycle variations.

What to Expect Moving Forward

With ever-increasing frequency, we hear of new initiatives all moving away from the static submission and review of PDFs to the far more dynamic submission of encoded data reliant on controlled vocabularies. Future iterations of IDMP within the EU will require a significant increase in the number of data points beyond those required for Iteration 1. Regulatory teams will be further reliant on cross-organizational input; from clinical and labeling as the requirements to report information on interactions, populations, and undesirable effects come into scope; and from manufacturing and CMC as the need for physical and characteristics for the packaged medicinal product are developed.

Building on IDMP, there are plenty of other initiatives to be aware of, including:

— DADI[i] project in the EU is looking to replace the e-AF and will align with IDMP on the use of FHIR[ii] resources

— UNICOM[iii] project is focusing on cross border e-prescription and increased pharmacovigilance

— PQ CMC[iv] project led by the FDA is looking at streamlining the submission of CMC as structured data and reviewing it via a Knowledge-aided Assessment and Structured Application (KASA).

In addition to all of the above and more, life sciences companies and vendors will need to contend with the introduction of eCTD 4.0 across multiple regions, and the fast-growing regulatory requirements for medical devices and veterinary products.

Conclusion

In summary, it is abundantly clear that future health authority requirements will focus on structured data reporting and this key area is where life sciences and vendors need to focus their attention.

Reference

[i] IDMP: Identification of Medicinal Products

[ii] EU: European Union

[iii] XEVMPD: Extended Eudravigilance Medicinal Product Dictionary

[iv] SPL: Structured Product Labelling

[v] e-AF: e-Application Forms

[vi] FDA: Food and Drug Administration

[vii] EMA: European Medicines Agency

[viii] UK: United Kingdom

[ix] MHRA: Medicines and Healthcare products Regulatory Agency

[x] API: Application Programming Interface

[xi] DADI: Digital Application Dataset Integration project

[xii] FHIR: Fast Healthcare Interoperability Resources

[xiii] UNICOM:

[xiv] PQ CMC: Pharmaceutical Quality/Chemistry Manufacturing & Controls


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