The purpose of this app is to use the data from MHRA and showcase how regulators currently manage and publish datasets that are of huge importance to members of the public, healthcare professionals and hospitals. However, due to low investment in technology, a number of regulators such as MHRA, SwissMedic, PMDA and the African Union struggle to surface this data in a structured, interactive, searchable format that increases the utility of those datasets.

This portal aims to highlight certain areas where regulators can use the data they hold, align with IDMP, and surface public data in a more usable and impactful fashion. This micro-site is a Proof of Concept that:

• Uses a number of AI tools such as Claude AI (for web app development) and OpenAI for coding of substances
• Delivers the solution using low-cost, open-source Python frameworks
• Showcases that a lot is possible with even the datasets regulators currently hold
• Makes a strong, compelling case for stronger collaboration with regulators

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. The regulator could offer a simple portal that:

• Allows companies to request Orphan Designation via a secure portal
• Provides a simple internal workflow for review and assessment
• Offers document exchange to support the application
• Once approved, automatically pushes data into the table exposed on the public portal
• Keeps all other datasets in the same environment but protected under a secure zone controlled using industry-standard RBAC

Browse Orphan Designations →

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 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.

Browse SMPC Listing →

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 →