Welcome to the Regulatory Data Portal
Regulators hold some of the most valuable healthcare data in the world
But much of it remains hard to access, search, and truly use. This portal reimagines how that data could be surfaced. Using publicly available datasets from agencies such as MHRA, SwissMedic and others, it demonstrates how regulatory information can be structured, aligned to IDMP, and made far more intuitive for patients, healthcare professionals and organisations.
Built as a proof of concept, this micro-site shows what’s possible today — using AI, open-source technologies,
and existing data — without the need for large-scale transformation programmes.
It highlights a simple idea:
with the right approach, regulators can unlock far greater value from the data they already hold.
Disclaimers: This portal uses publicly available data and is not an official source of regulatory information.
It is intended for demonstration purposes only and should not be used for clinical decision-making or regulatory compliance.
The datasets used may not be comprehensive or up-to-date, and the portal does not reflect the full scope of regulatory
data held by agencies. It uses:
- The baseline data for this micro-site is sourced from MHRA's product portal. Hence the subdomain is dedicated to MHRA
- The Substances data for this micro-site is sourced from EMA's SPOR product portal
- The portal also demonstrates ability to use OpenFDA APIs
Sections of this Micro-App
Digitised SMPC
The SMPC (Summary of Product Characteristics) is a structured document. If the sections of the PDF are extracted into a database, the utility of the data increases manifold. The FDA offers APIs under its OpenFDA framework, but other regulators struggle to offer a similar service. This is essantially the first version of ePI (electronic Product Information) that the regulator could offer to the public, healthcare professionals and hospitals.
This service takes approximately 400 SMPCs, digitises them, and makes them available as a searchable public portal — demonstrating how regulators could easily make their existing document libraries far more accessible and useful.
Day 1 Benefits- First step toward electronic Patient Information (ePI)
- Reinforce regulator’s image as trustable, collaborative provider of Medicinal product data
- Drive transparency and improved patient and Healthcare engagement
IDMP Product Master
One of the core challenges regulators face is that their existing datasets were not built with IDMP in mind. This section demonstrates how data already held in a regulatory system can be restructured and surfaced in an IDMP-aligned hierarchy — Marketing Authorisation → Medicinal Product → Administrable Product — without replacing the underlying source systems.
This is a key proof point: regulators do not need to start from scratch to achieve IDMP compliance. With appropriate transformation tooling, existing data can be mapped to ISO 11615 / ISO 11616 structures incrementally.
Strategic Benefits- Intitiate your IDMP transformation.
- Strong foundation to surface core three datasets in IDMP compliant structure
- Get ready for PhpId ingestion
- All Pharmacovigilance use cases can be satisfied with this dataset.
Orphan Designations
This page shows a listing of all products that have current and past Orphan Designations. The page demonstrates a potential option where data can be surfaced in a simple listing instead of a CSV download. Once data is available in a database, the regulator can automate the end-to-end journey for Orphan Designation management.
Orphan Designation review is usually undertaken as a mini-process running in parallel with the Marketing Authorisation. Availability of structured data on SMPC can enable end to end automation of the Orphan Designation process. The process is desgined with regulators in mind.
Drive Innovation- Allows companies to request Orphan Designation via a secure portal providing encouragement for pharma companies to launch orphan drugs
- Provides a simple internal workflow for review and assessment
- Enable transparency on Exclusivity dates and review dates for products with orphan designation.
- Make your country a better place to do business with.
Request Orphan Designation
Companies wishing to apply for Orphan Designation can submit their application directly through this portal. The structured online form guides applicants through all required sections:
- Section A — Description of condition (definition, aetiology, characteristics, diagnosis, medical plausibility, active substance)
- Section B — Prevalence of the condition
- Section C — Potential for return on investment
- Section D — Other methods / existing treatments
- Section E — Description of stage of development
- Section F — Bibliography
Supporting documents and attachments can be uploaded alongside each section. Login is required to access this form.
Start Orphan Designation Application →Digitise your procedural steps
Baseline IDMP dataset would allow regulators to digitise the procedural steps for processing any Marketing Authorisation application. Information and dataset published in the IDMP view above is classified as "public" information and can be safely used as basis to enable online jounry to request "more information" (RFIs) or "request correction of data" (called VCRs in the UK). the journey can be deisgned to refernce specific eCTD sections or document names against which clarification is being sought.
This would allow regulators to move away from email-based communication and manual processing of RFIs and VCRs, and instead have a fully digitised, auditable workflow for these procedural steps.
Improve Regulatory Efficiency- User friendly interface
- Provides a simple internal workflow for review and assessment
- Eradicate dependence on Word documents and pdfs but still retain ability to generate one and add them to your eCTD sequence for compliance and lifecycle management
- Get ready to embrace “Cloud Based Regulatory Systems” by enabling APIs that allow you to adapt them and not force you to Adopt one