Tarius Base Module: Human Drugs contains reference documents relating to the full life-cycle management of pharmaceutical products with regard to Efficacy, Safety and Quality issues as well as registration procedures. The database is relevant for QA and QC staff monitoring company compliance with regard to GLP, GCP and GMP guidelines as well as for RA professionals responsible for the submission and maintenance of registration documentation.

Why subscribe to a professional database?

• Replace the tedious task of manually checking the same sites every day, submitting to search engines or testing web sites over and over again.
• Be sure to identify the current version of authority documents.
• Secure the consistency and quality of your monitoring independent of staff shortages.
• Access a structured archive of information when you need to search and retrieve documents, including superseded versions.
• Be notified via email of newly published documents within your scope of interest.

What is included in the Annual Subscription Fee?
Included in your Annual Subscription Fee are a personal user ID and a password for access to the daily updated archive of information, including also:

• Global intelligence - search across US and EU regulations in one operation,
• Daily updates – new publications are automatically added to your subscription on a daily basis,
• Weekly email alert – sign up to receive news via email
• Clear indication of document status - whether "draft", "in force" or "superseded",
• Thematically organized – the detailed table of contents lets you navigate step by step,
• Highlighted search terms in documents - opening a document from the Search Hit List, search terms are automatically highlighted,
• Save your favourite search expressions – repeat targeted searches including also newly published documents to your search hit list,
• Personal bookmarks – speed up later retrieval of favourite documents,
• And more.

What are the contents in Tarius Base Module: Human Drugs?
This online product is your ultimate resource for finding answers to US and EU regulatory and quality questions related to Human Drugs. It provides, in one location, access to thousands of documents, including:

US Legislation: Tarius includes relevant US Acts administered by the Food and Drug Administration.
US Code of Federal Regulations: Relevant parts from 21 CFR including amendments as published in the Federal Register (proposed rules and finalized rules). In addition, 45 CFR Part 46 (Public Welfare; Protection of Human Subjects) is included.
US FDA Reference Documents: Tarius Base Module: Human Drugs contains all relevant guidance for industry, Compliance Policy Guides (CPG), points-to-consider, manuals (CPGM, RPM, SOPs and MaPPs) and forms from the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). CDER and CBER Advisory Committee public meeting notices, agendas, etc. as well as FDA Warning Letters and Notice of Violation Letters related to Human Drugs are included.
US DEA Reference Documents: FR notices of application related to import and manufacture of controlled substances, aggregate production quotas, etc. are included.
US Agreements with other countries: The module includes international agreements between USA and third countries (Canada, EU, Australia, Japan, etc) on the exchange of pharmaceutical information.
EU Regulations and Directives: Tarius Base Module: Human Drugs offers a comprehensive presentation of all Regulations and Directives adopted by the European Council and the European Commission on medicinal products for human use and biotechnology.
EU Commission and EMEA Reference Documents: All the guidelines laid down by the EU Commission and EMEA on quality, safety and efficacy requirements as well as on adverse events reporting and regulatory affairs. The European Public Assessment Reports reflecting the scientific conclusions at the end of the centralized evaluation process for a product and EMEA SOPs providing knowledge on how the EMEA works through inspections and the different business procedures are also included.
EU CMD(h) Documents: Guidance documents, reports, SOPs, FAQ’s, etc. from the Heads of Medicines Agency are included.
EU agreements with other countries: Agreements on mutual recognition between EU and third countries (Australia, Canada, Japan, New Zealand, Switzerland, USA, etc).
ICH: The module offers a complete and updated presentation of all guidelines issued by The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Draft guidelines are included from step 2 in the ICH process. For guidelines that are implemented in the US and/or the EU, hyperlinks provide direct access to the relevant US/EU guidelines.
PIC/S and WHO: Guidance documents published by PIC/S (The Pharmaceutical Inspection Co-Operation Scheme) and WHO are also included.
BIO, EFPIA, PhRMA and IPPMA: News releases from these professional organizations are monitored and included in the module.