The approvals data in the regulatory section comes from official regulator data of each market. The open data below is reused under licences that ask for this notice. Data that is in the public domain is not listed.
Centrally authorised medicines (European Medicines Agency medicines data)
Licence: Reuse of European Medicines Agency information is allowed under its reuse policy, with acknowledgement of the source.
Source: European Medicines Agency. The agency does not endorse this site or the way the data is presented.
Notice of Compliance database and Medical Devices Active Licence Listing (Health Canada)
Licence: Open Government Licence - Canada.
Contains information licensed under the Open Government Licence - Canada.
Lists of marketing authorisations granted (Medicines and Healthcare products Regulatory Agency)
Licence: Open Government Licence v3.0.
Contains public sector information licensed under the Open Government Licence v3.0.
Public database of medicines (Base de données publique des médicaments)
Licence: Licence Ouverte / Open Licence 2.0 (Etalab).
Source: Base de données publique des médicaments, data reused and changed (filtered and mapped).
Online medicines information service (CIMA, Spanish Agency of Medicines and Medical Devices)
Licence: Reuse allowed with the source named.
Source: CIMA, Spanish Agency of Medicines and Medical Devices.
Open data list of authorised medicine packs (Italian Medicines Agency)
Licence: Italian Open Data Licence 2.0.
Source: Italian Medicines Agency (AIFA) open data.
Drug and medical device licences (Taiwan Food and Drug Administration open data)
Licence: Open Government Data License, version 1.0.
Source: Taiwan Food and Drug Administration open data.
Registered therapeutic products and medical devices (Health Sciences Authority)
Licence: Singapore Open Data Licence version 1.0.
Contains information from the Health Sciences Authority, made available under the Singapore Open Data Licence version 1.0.
Lists of authorised human medicines (Swissmedic)
Licence: Published lists of the regulator.
Source: Swissmedic lists of authorised medicinal products.
Open data on medicine and health product registrations and review cycles (Brazilian Health Regulatory Agency)
Licence: Open data of the regulator.
Source: Agência Nacional de Vigilância Sanitária (ANVISA) open data.
The pathway descriptions (steps, requirements, time targets and fees) are our own summaries of the official laws, regulations and guidance, checked on the date shown on each page. Data was changed from the original: it was filtered, combined, mapped to shared pathway types and matched to listed companies. Not legal or regulatory advice. Check the current official rules before you act.