Included are some links we hope will serve as references and resources. We recommend that you keep checking back for up-to-the minute regulatory and international news in the bio- and pharmaceutical sectors.
REGULATORY BODIES
Regulatory Authorities in Europe
European Agency Medicines (EMA)
http://www.emea.europa.eu
Heads of Medicines Agencies (HMA)
http://www.hma.eu
European Commission Public Health Website
http://ec.europa.eu/health/index_en.htm
DG Enterprises – Pharmaceuticals – Regulatory Framework and Market Authorisations
http://ec.europa.eu/enterprise/index_en.htm
European National Authorities
Austria: Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
http://www.ages.at
Belgium: Federal Public Service – Health, Food chain safety and Environment
http://www.health.belgium.be/eportal
Bulgaria: Bulgarian Drug Agency (BDA)
http://www.bda.bg
Cyprus: Ministry of Health
http://www.moh.gov.cy
Czech Republic: State Institute for Drug Control (SÙKL)
http://www.sukl.cz
Denmark: Lægemiddelstyrelsen (DKMA)
http://www.dkma.dk
Estonia: State Agency of Medicines
http://www.sam.ee
Finland: Finnish Medicines Agency
http://www.fimea.fi
France: Agence Nationale de Sécurité du Medicaments et des produits de santé (ANSM)
http://ansm.sante.fr/
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
http://www.bfarm.de
Greece: National Organization for Medicines
http://www.eof.gr
Hungary: National Institute of Pharmacy
http://www.ogyi.hu
Iceland: Icelandic Medicines Control Agency (IMCA)
http://www.imca.is
Ireland: Health Products Regulatory Authority (HPRA)
http://www.hpra.ie/
Italy: Agenzia Italiana del Farmaco (AIFA)
http://www.agenziafarmaco.gov.it/
Latvia: State Agency of Medicines
http://www.zva.gov.lv
Lithuania: State Medicines Control Agency
http://www.vvkt.lt
Luxembourg: Ministère de la Santé
http://www.etat.lu/MS
Malta: Medicines Authority
http://www.medicinesauthority.gov.mt
Netherlands: College ter Beoordeling van Geneesmiddelen
http://www.cbg-meb.nl
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
http://www.legemiddelverket.no
Poland: The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
http://www.urpl.gov.pl
Portugal: National Medicines and Health Products Authority (INFARMED)
http://www.infarmed.pt
Romania: National Agency of Medicines and Medical Devices (ANM)
http://www.anm.ro
Slovak Republic: State Institute for Drug Control (SIDC)
http://www.sukl.sk
Slovenia: Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (JAZMP)
http://www.jazmp.si
Spain: Agencia Española de Medicamentos y Productos Sanitarios
http://www.aemps.gob.es
United Kingdom: Medicines and Healthcare Products Regulatory Agency (MHRA)
http://www.gov.uk/mhra
Sweden: The Medical Products Agency
http://www.lakemedelsverket.se/enga
Switerland: Swiss Agency for Therapeutic Products
http://www.swissmedic.ch
Regulatory Authorities in The Americas
North America
Canada: Health Canada – Health Products and Food Branch
http://www.hc-sc.gc.ca
Mexico: Ministry of Health
http://www.salud.gob.mx/
USA: Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER)
http://www.fda.gov/cder
Central & South America
Argentina: National Administration of Drugs, Foods and Medical Technology
http://www.anmat.gov.ar
Bolivia: Health Ministry
http://www.minsalud.gob.bo/
Brazil: Ministry of Health
http://portalsaude.saude.gov.br/
Chile: Health Ministry
http://www.minsal.cl
Colombia: Health Ministry and Social Protection
http://www.minsalud.gov.co/sites/english/Pages/default.aspx
Costa Rica: Health Ministry
http://www.ministeriodesalud.go.cr
Ecuador: Ministry of Public Health
http://www.salud.gob.ec/
Guatemala: Ministry of Public Health
http://portal.mspas.gob.gt
Panama: Health Ministry
http://www.minsa.gob.pa/
Paraguay: Ministry of Public Health
http://www.mspbs.gov.py/v3/
Peru: Ministry of Health
http://www.minsa.gob.pe/
Uruguay: Ministry of Public Health
http://www.msp.gub.uy/
Venezuela: Ministry of Health and Social Development
http://www.mpps.gob.ve/
Regulatory Authorities in Asia
India: Ministry of Health & Family Welfare
http://mohfw.nic.in/
Indonesia: Ministry of Health
http://www.depkes.go.id/
Israel: Ministry of Health
http://www.health.gov.il/english/Pages/HomePage.aspx
Japan: Ministry of Health, Labour and Welfare
http://www.mhlw.go.jp/english/index.html
Jordan: Ministry of Health
http://www.moh.gov.jo
Korea: Ministry of Food and Drug Safety
http://www.kfda.go.kr/index.jsp
Lebanon: Ministry of Public Health
http://www.moph.gov.lb/Pages/Home.aspx
Malaysia: National Pharmaceutical Control Bureau
http://portal.bpfk.gov.my/
Philippines: Department of Health
http://www.doh.gov.ph/
Singapore: Ministry of Health
http://www.moh.gov.sg/content/moh_web/home.html
Taiwan: Ministry of Health and Welfare
http://www.mohw.gov.tw
Thailand: Food and Drug Administration
http://www.fda.moph.go.th/
United Arab Emirates: Ministry of Health
http://www.moh.gov.ae/en/Pages/default.aspx
Regulatory Authorities in Oceania
Australia: Australian Government Department of Health and Ageing
http://www.health.gov.au/
New Zealand: Medicines and Medical Devices Safety Authority
http://www.medsafe.govt.nz/
Regulatory Authorities in Africa
Algeria: Ministry of Public Health
http://www.sante.dz/
Egypt: Ministry of Health
http://www.mohp.gov.eg/default.aspx
Ethiopia: Ministry of Health
http://www.moh.gov.et/home
Ghana: Ministry of Health
http://www.moh-ghana.org/
Liberia: Ministry Health & Social
http://www.mohsw.gov.lr/
Morocco: Ministry of Public Health
http://www.sante.gov.ma/Pages/Accueil.aspx
Nigeria: Federal Ministry of Health
http://www.health.gov.ng/
République Démocratique du Congo: Ministry of Public Health
http://www.minisanterdc.cd/new/index.php
Rwanda: Ministry of Health
http://moh.gov.rw/
South Africa: Department of Health
http://www.doh.gov.za/
South Sudan: Ministry of Health
http://www.mohss.org/
Tanzania: Ministry of Health and Social Welfare
http://moh.go.tz/
Uganda: Ministry of Health
http://health.go.ug/mohweb/
Zambia: Ministry of Health
http://www.moh.gov.zm/
Zimbabwe: Ministry of Health and Child Welfare
http://www.mohcc.gov.zw/
ORGANIZATION, COMMISSIONS, FEDERATIONS, AND INSTITUTIONS
Worldwide
World Health Organization (WHO)
http://www.euro.who.int/en/home
Pan American Health Organization (PAHO)
http://new.paho.org/
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
http://www.ich.org/
International Federation of Pharmaceutical Manufacturers and Associates (IFPM)
http://www.ifpma.org
Drug Information Association (DIA)
http://www.diahome.org/DIAHome/Home.aspx
Pharmaceutical Information & Pharmacovigilance Association
http://www.pipaonline.org/
The Organisation for Professionals in Regulatory Affairs (TOPRA)
http://www.topra.org/
Europe
Association of the European Self-Medication Industry (AESGP)
http://www.aesgp.be
BioIndustry Association (BIA)
http://www.bioindustry.org
Drug3k – Online Drug Encyclopedia
http://www.drug3k.com
Eudralex
http://ec.europa.eu/health/documents/eudralex/index_en.htm
European Pharmacopoeia
http://www.edqm.eu/site/background-50.html
European Federation of Pharmaceutical Industries and Associations (EFPIA)
http://www.efpia.eu/
European Directorate for the Quality of Medicines and Healthcare (EDQM)
http://www.edqm.eu/site/page_628.php
European Generic Medicines Association (EGA)
http://www.egagenerics.com
European Pharmaceutical Legislation
http://ec.europa.eu/health/documents/eudralex/index_en.htm
