RegulatedAuthorization FHIR Resource Proposal
- 1 RegulatedAuthorization
- 1.1 Owning work group name
- 1.2 Committee Approval Date:
- 1.3 Contributing or Reviewing Work Groups
- 1.4 FHIR Resource Development Project Insight ID
- 1.5 Scope of coverage
- 1.6 Resource appropriateness
- 1.7 Expected implementations
- 1.8 Content sources
- 1.9 Example Scenarios
- 1.10 Resource Relationships
- 1.11 Timelines
- 1.12 gForge Users
- 1.13 When Resource Proposal Is Complete
- 1.14 FMG Notes
Draft resource in build:
Owning work group name
Committee Approval Date:
6th May 2019 (earlier approval as "MedicinalProductAuthorization" 13th September 2017)
Contributing or Reviewing Work Groups
FHIR Resource Development Project Insight ID
Scope of coverage
Regulated items - those subject to local, regional or international legislation for their use - are subject to authorization procedures and outcomes.
These authorizations, and the items they relate to, need to be tracked and made available.
Regulatory systems keep full details of authorisations, and these may be referenced by other users to check the legal and usage parameters of a medicinal product, or a device.
The item that is being authorized (e.g. reference to a product or device)
The holder (receiver) and the regulator (creator) of the authorization.
Type of authorisation - Marketing approval (or suspension), orphan drug approval, special uses for veterinary medication etc.
Status, e.g. pending, approved, withdrawn.
Location of applicability, local, regional, national etc.
Dates of application, granting, and associated dates such as special case initial periods, end dates, renewal dates etc.
The legal framework under which the authorisation was granted (e.g. EU CAP Centrally Authorised Product).
There is an outstanding requirement to support the standardised exchange of detailed "Product" data, for regulatory and other use cases.
Regulators (EMA, FDA, and national "Competent Authorities"), as well as more local organisations, hospital and payer networks etc, need to record the legal authorizations that apply to medicinal products. This is a key focus of what organizations such as FDA and EMA do - they regulate and authorize the marketing of drugs.
EMA and European drug manufacturers, who have a requirement to submit to EMA (and already do so in a proprietary format). They are required to move to IDMP, and this is a good opportunity to use a standards-based FHIR solution.
FDA for drug submission (currently using SPL, which is not likely to change in the near term, but have expressed an interest in FHIR).
FDA for Pharmaceutical Quality (HL7 PSS approved, based on this resource, June 2019),
The core basis for the resource is the information in ISO 11615 Medicinal Products standard, which is in turn partly based on the existing implementations in the EU and US. A large amount of actual data exists in the EMA EU XEVMPD data base (and XEVPRM XML messages). Example FHIR data for several full product data sheets exists based on draft resources.
Also, information gained from early stage implementation of these resources at EMA (2018, 2019), and from many many received to EMA about the draft API specification from the European medicines regulatory network (https://www.ema.europa.eu/en/about-us/how-we-work/european-medicines-regulatory-network).
Also from FDA requirements (for PQ/CMC) and other workgroup review (BR&R, Pharmacy) and their comments.
Pharma companies submit details of new products to regulators, and include authorization details, which in turn may be updated by the regulators.
Pharmacies and prescribers can view and download this information for reference and integration with their systems.
Specific use cases include:
Submission of products from drug companies and NCAs (National Competent Authorities - the national regulators) to regional regulators.
This is already implemented in Europe (by EMA and EU-wide stakeholders) with an earlier non-HL7 format (XEVPRM/XEVMPD). That scenario is currently being re-implemented, using this resource, as part of the EU wide SPOR project.
See diagram below.
Some notable resource references: Reference to Organization, for the licence holder and the regulator that establised the authorization/licence. Reference to RegulatedMedicinalProduct or RegulatedPackagedProduct as the subject, that is authorized.
Also refer to the logical model which was used to clarify the resource relationships, at the request of FMG, in the preparation of this proposal (linked to the approved MedicationKnowledge proposal page): MedicationKnowledge_FHIR_Resource_Proposal
High level relationships of the main prescribing resources and the regulatory strata below:
Draft content is modelled in the FHIR build (http://build.fhir.org/regulatedauthorization.html), with outline supporting documentation. Completion planned Q4 2019.
When Resource Proposal Is Complete
When you have completed your proposal, please send an email to FMGcontact@HL7.org