Reference Documents from National Authorities

Legislative Documents from Parliament, Ministry of Health, Agencies

National Parliaments and Ministries of Health publish a large number of document categories such as Acts/Laws (Codes), Executive Orders, Resolutions, Instructions, Decisions, Policy Papers, Circular Letters, etc. Furthermore, the national healthcare agencies support the interpretation and implementation of the laws and orders by issuing numerous Guidelines, Guidance documents, Forms and Templates, Meeting Minutes from expert committees, Agency Memoranda of Understanding (MOU’s), Reports, etc.

Tarius monitors more than 250 websites and Official Journals on a daily basis in order to consolidate all of these documents into your web portal. All documents are provided with a rich set of English metadata (title, abstract, key topics, etc) enabling you to search in English for non-English documents. More than 225.000 legislative documents are available in the Tarius Web Portal!

Draft, Enforced and Archive Versions

Tarius provides access to draft versions as well as enforced documents, including a clear indication of the legal status of each document and direct hyperlinks between the versions. All superseded documents are kept in the web portal to guarantee the traceability of the history of a document and to support you during regulatory inspections.

English Metadata Facilitates Database Searches

National documents are provided in the authentic version as published by the national authorities. English metadata are added to each document (title, keywords, abstract, legal status, effective date, etc.) to enable you to easily search among the documents to find what you need. English translations are added, when available. In fact, English translations are available for more than 25% of Tarius’ non-English documents.

Business Intelligence

Tarius includes a comprehensive compilation of more than 50.000 product-specific documents, supporting business intelligence as well as regulatory strategy and compliance. These documents include FDA Product Approvals, FDA Warning Letters and Cyber Letters, EU Assessment Reports (EPARs), EU Referrals, EU Paediatric Investigation Plans (PIPs), EU Orphan Designations, EU Withdrawals, EU Safety Alerts, HMA Assessment Reports, U.K. Assessment Reports, U.K. Alerts and U.K. Field Safety Notices, Australian Assessment Reports, Australian Alerts and Recalls, Japan PMDA Review Reports, PMDA Safety Information, Canada Summary Basis of Decision and much more.

Tracking What International Organizations Are Doing

In addition to our comprehensive database of national authorities’ documents, Tarius also provides guidelines, reports and policy papers from these international organizations:

  • For Medical Devices and IVDs: EDMA, Eucomed, IMDRF, WHO, ISO and ASTM (Bibliographic data and news)
  • For Human Drugs and Biologics: CIOMS, ICH, OECD, PIC/S, WMA, WHO