International BioPharm Initiatives - BioPharm International

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International BioPharm Initiatives

Pharmaceutical, biologics, and device regulations vary from country to country. In Europe, the European Agencay for the Evaluation of Medicinal Products (EMEA) governs pharmaceutical regulation in all member states of the European Union. Along with regulatory agencies of the United States and Japan, they are working toward harmonizing those regulations worldwide, through the International Conference on Harmonization (ICH).

Approved drugs in Europe. The EMEA publishes information on the products assessed by the Committee for Medicinal Products for Human Use (CHMP). Any positive opinion given by the Committee is published in the first instance as a Summary of Opinion. More detailed information is published later, following the granting of a Marketing Authorization by the European Commission as an European Public Assessment Report (EPAR).

European Guidelines. The EMEA’s Committee for Medicinal Products for Human Use (CHMP) prepares scientific guidelines, in consultation with the competent authorities of the EU Member States, to help applicants prepare marketing-authorization applications for medicinal products for human use.

The Multilingual Glossary of Technical and Medical Terms in Nine European Languages. This site was commissioned by the European Commission.

The European National Medicines Authorities window is the common web site for the medicine authorities in the European Union. The window serves as a connection point to other agencies' own web sites.

Eudra Information and Communication Projects.

The European Commission’s Pharmaceutical Unit runs a variety of information and communication projects, collectively known as “Eudra” projects. There are four key Eudra projects.

  • EudraNet – Electronic network The European Union Drug Regulatory Network (EudraNet), is an electronic communications system that allows Member State authorities to exchange information with the EMEA and the European Commission
  • EudraTrack – Mutual recognition procedure of marketing authorizations The EudraTrack workflow application helps Member States to keep track of mutual recognition procedure applications.
  • EudraWatch – Pharmacovigilance The EudraWatch service for the electronic transmission and management of pharmacovigilance reports
  • EudraLex – Community legislation The Pharmaceutical Unit makes Community pharmaceutical legislation, guidelines, the Notice to Applicants and other relevant Community texts available on the web server 18 . A EudraLex CD-ROM, which will enable users to link up directly to the web site and to keep track of legislative changes, should be available early in the new millennium

Eudra web sites

The Pharmaceutical Unit web site provides access to practical information (such as the Community register of medicinal products, membership and meeting dates of Commission committees on human and veterinary medicines, etc), as well as to draft pharmaceutical legislation and policy documents. It is also a gateway to Eudralex.

The European Commission’s EUROPA server provides access to press releases, gateways to various Commission departments, and links to the home pages of other institutions and EU satellite agencies.

The Official Journal of the European Communities can be viewed on http://europa.eu.int/eur-lex. EUR-Lex provides free access to the C and L series of the Official Journal for 20 days after publication, to the EU Treaties (both consolidated and undergoing the ratification process), to EU legislation in force (including consolidated versions), and to recent judgments of the Court of Justice.

The Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme (PIC/S). T he PIC Scheme is a cooperative arrangement between health authorities in European member states to ensure GMP compliance and mutual recognition of inspections.

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates drugs and medical devices in the UK.

The Irish Medicines Board licenses medicines for humans and animals, inspects manufacturing facilities, monitors clinical trials, and maintains drug safety.

Health Canada regulates drugs in Canada.

The Therapeutic Goods Administration is Australia's compliance-related site maintained by the Australian Department of Health and Aged Care.

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) The web site offers news and information on the ICH process, guidelines and topics, and conferences. ICH documents can be downloaded at www.ich.org

Japan's Ministry of Health and Welfare is responsible for controlling the medical supply in Japan. The web site provides information on compliance issues. MWH is a member of the International Conference on Harmonization (ICH).

The European Directorate for the Quality of Medicines offers regulatory compliance news, publications, and reference materials.

The World Health Organization (WHO) provides global guidance on essential drugs and medicines (EDM), and works with countries on the implementation of national drug policies to ensure equity of access to essential drugs, drug quality and safety, and rational use of drugs. The web site offers downloadable information on policies and guidelines.

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