DDA Drug Registration Portal
Jan 2026, revamped Nov 2026 · Team of four · Full stack · by Abhiyan Khanal
A portal for filing and reviewing drug registration dossiers with Nepal's Department of Drug Administration. Applicants file a dossier split into the five modules of the ICH Common Technical Document, reviewers assess each module and raise queries, and a lead reviewer assigns the work and makes the final decision. We built it as team Char Devs at the hackathon of the 4th National Telemedicine & 1st National Digital Health Conference, where it placed 1st runner-up.
Features
- Product registration and a step-by-step dossier wizard for CTD Modules 1–5
- Reviewer queue with a module review page, assessment checklist and queries
- Lead reviewer board to assign modules, track reviewer workload and issue the final decision
- Role-based access with JWT for applicants, reviewers, lead reviewers and admins
- Public patient information leaflet lookup on the landing page
The problem
Registering a drug in Nepal means sending the DDA a large dossier, and reviewing it involves several assessors working on different parts at once. We wanted one place where an applicant can see exactly which part of their dossier is stuck and why, and where the lead reviewer can see who is working on what.
Applicants
- Register a product with its brand and generic name, ATC code, strength, dosage form, route and type (NDA, ANDA, API or biological).
- File a dossier through a step-by-step wizard that only asks for the CTD modules the product type needs, with document uploads. Save it as a draft or submit it to the DDA.
- Track every application module by module, and answer reviewer queries with extra documents from the submission page.
Reviewers and the lead reviewer
- Reviewers get a queue of the modules assigned to them. The review page shows the uploaded documents, the applicant's declared data and the query history next to a checklist, and the reviewer approves the module, keeps it under review or rejects it.
- Raising a query moves both the module and the submission to Query raised; once the applicant answers, they move back to Under review.
- The lead reviewer has a review board with filters for submissions that need assignment, have open queries or are ready for a decision. They assign modules to reviewers and can see each reviewer's workload. Final approval only unlocks when every module is approved, and a rejection needs a reason.
- Module 3 quality data (active ingredients, excipients, formulas, manufacturing process, stability and packaging) is modelled in the database, not just attached as PDFs.
The revamp
The hackathon version worked for a demo but trusted whoever the request headers said you were. In November 2026 I went back and made it something I'd be comfortable deploying.
- JWT authentication with role guards on every route (APPLICANT, REVIEWER, LEAD_REVIEWER, ADMIN) and ownership checks so applicants only see their own data. Identity now only comes from the token.
- Status transitions are enforced on the server, so a draft can't be approved and a submission can't be submitted twice.
- Removed a database credential that had been committed to the repo.
- Uploads go to local disk in development, or to Vercel Blob when a token is set.
- An idempotent seed script creates demo data covering every status, Postgres runs from Docker Compose, and GitHub Actions runs CI.
- A redesigned UI with a shared design system, one-click demo accounts on the sign-in page and layouts that work on phones.
Stack
The frontend is React 19 and TypeScript with Vite, Tailwind CSS v4 and React Router, with typed API clients sharing one fetch helper. The backend is Node.js and Express 5 in TypeScript, with Prisma 7 on PostgreSQL, a REST API under /api/v1 split into routes per resource, and Multer for uploads.
Tech stack
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