Formulation Development

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Featured Publication
Recent Options for Phase 1 Formulation Development and Clinical Trial Material Supply. By: Balaji V. Kadri - Featured in the August 2008 Issue of Pharmaceutical Technology







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Regulatory Agencies

CLICK ON THE LINKS FOR MORE INFORMATION:

European Union
EMEA, European Agency for the Evaluation of Medicinal Products

7 Westferry Circus, Canary Wharf, London E14 4HB UK
EMEA, What's New! Just published...
EMEA, Human Medicines page
EMEA, What's New in the Inspectors Sector

European National Authorities Medicines Window
Product Index

European Commission (EC), EUR-Lex
EC Official Journal


National Competent Authorities in Europe

Austria - Bundersministerium Für Gesundheit und Frauen

Belgium - Ministry of Social Affairs, Public Health & Environment

Bulgaria - The Bulgarian Drug Agency

Czech Republic - Státní Ústav Pro Kontrolu Léèiv
English Information

Denmark - Lægemiddel Styrelsen
English Information

Estonia - Ravimiamet

Finland - National Agency for Medicines
English Information

France - Agence Française de Sécurité Sanitaire des Produits de Santé (Afssaps)
English Information

Germany - Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
English Information

Germany - Paul-Ehrlich-Institut (PEI)
English Information

Greece - National Organisation for Medicines
English Information

Hungary - Országos Gyógyszerészeti Intézet
English Information

Iceland - Lyfiastofnun
English Information

Ireland - Irish Medicines Board

Italy - Agenzia Italiana del Farmaco (AIFA)

Latvia - Valsts Zalu Agentura

Liechtenstein - Amt Für Lebensmittelkontrolle und Vetreinärwesen

Lithuania - State Medicines Control Agency of Lithuania

Luxembourg - Ministère de la Santé

Norway - Statens legemiddelverk

Poland - Urzad Rejestracji Produków Leczniczych, Wyrobów Medycznych i Produktów Biobójczych

Portugal - Instituto Nacional de Farmácia e do Medicamento (Infarmed)
English Information

Romania - Agentia Nationala a Medicamentului
English Information

Slovenia - Institut za Varovanje Zdravja
Spain - Agencia Española del Medicamentos
English Information

Switzerland - Swissmedic
English Information

The Netherlands - College ter Beoordeling van Geneesmiddelen
English Information

United Kingdom - Medicines and Healthcare products Regulatory Agency (MHRA)

United States

US Food and Drug Administration (FDA)
5600 Fishers Lane, Rockville MD 20857-0001 USA
FDA Center for Biologics Evaluation and Research (CBER)
CBER Reading Room (Electronic Freedom of Information Act)
FDA Center for Drug Evaluation and Research (CDER)
FDA Center for Devices and Radiological Health (CDRH)

National Institutes of Health, NIH
NIH Telephone and E-Mail Directory
National Library of Medicine Pub-Med (Search the medical literature.)

Code of Federal Regulations, CFR US National Archives and Records Administration
CFR Title 21, Food and Drugs


International Organizations

ICH, International Conference on Harmonisation
World Health Organization, WHO

Australia

http://www.health.gov.au/

Canada

Health Products and Food Branch, Health Canada

Japan

Ministry of Health, Labour and Welfare




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