Find out more about GaBI's second pillar - GaBI Journal
A. Useful Links - General
Below you can find a list of useful links to associations, NGOs and regulatory agencies from Africa, Asia, Europe, Middle East, North America and South America. We update the content of this section regularly to provide users/visitors with the most current information. Please feel free to let us have your feedback on other useful links to be included in this section.
Africa
South Africa - National Association of Pharmaceutical Manufacturers: www.napm.co.za
Asia
India - Indian Pharmaceutical Association: www.ipapharma.org
Japan - Generic Medicines Association: www.jga.gr.jp/english/index.html
Taiwan - Generic Pharmaceutical Association: www.tgpa.org.tw
Europe
Austria - Österreichischer Generikaverband (Austrian Generics Association): www.generikaverband.at
Belgium - Federatie Belgische Generische Geneesmiddelen (Belgian Generics Federation): www.febelgen.be
Bulgaria - Bulgarian Generic Pharmaceutical Association: www.bgpharma.bg
Czech Republic - Czech Pharmaceutical Association: www.aff.cz
Denmark - Danish Generic Medicines Industry Association: www.igldk.dk
Finland - Finnish Generics Association: www.xn--rinnakkaislkkeet-5nba.fi
France - Générique même medicament: www.medicamentsgeneriques.info
Germany - Deutscher Generikaverband (German Generics Association): www.generika.de
Germany - Pro Generika: www.progenerika.de
Italy - Associazione Nazionale Industrie Farmaci Generici Aderente all'European Generic Medicines Association: www.assogenerici.org/2011/
Poland - Polskiego Związku Pracodawców Przemysłu Farmaceutycznego: www.pzppf.com.pl
Portugal - Apogen - Associação Portuguesa de Medicamentos Genéricos: www.apogen.pt
Spain - Asociación Española de fabricantes de Sustancias y Especialidades farmacéuticas Genéricas: www.aeseg.es
Sweden - Föreningen för Generiska Läkemedel: www.generikaforeningen.se
The Netherlands - Bond van de Generieke Geneesmiddelenindustrie Nederland (Generic Medicicines Association NL): www.bogin.nl
Turkey - Pharmaceutical Manufacturers Association of Turkey: www.ieis.org.tr
United Kingdom - British Generic Manufacturers Association: www.britishgenerics.co.uk
Middle East
Jordan - Jordanian Association of Pharmaceutical Manufacturers: www.japm.com
North America
Canada - Canadian Generic Pharmaceutical Association: www.canadiangenerics.ca/en/index.asp
Canada - Health Canada www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/bio/index-eng.php
USA - Biotechnology Industry Organization: www.bio.org
USA - Generic Pharmaceutical Association: www.gphaonline.org
USA - Health and Safety Initiatives + Health Research Group: www.publiccitizen.org
USA - International Network for the Rational Use of Drugs: www.inrud.org
USA - Office of Generic Drugs: www.fda.gov/AboutFDA/CentersOffices/cder/ucm119100.htm
USA - US Food and Drug Administration: www.fda.gov
South America
Brazil - Associação Brasileira das Indústrias de Medicamentos Genéricos (Generic Medicines Association of Brasil): www.progenericos.org.br
General - Related Organisations
Association Internationale de la Mutualité: www.aim-mutual.org
Bureau Européen des Unions de Consommateurs (The European Consumers' Organisation): www.beuc.org
College ter Beoordeling van Geneesmiddelen (Medicines Evaluation Board): www.cbg-med.nl/cbg/en/default.htm
Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh): www.hma.eu/cmdh.html
European Generic medicines Association: www.egagenerics.com
European Medicines Agency: www.ema.europa.eu
European Public Health Alliance: www.epha.org
Heads of Medicines Agencies: www.hma.eu
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): www.ich.org
International Pharmaceutical Federation (FIP) : www.fip.org/bcs
Knowledge Ecology International: www.keionline.org
Medicins Sans Frontiers (Doctors without Borders): www.accessmed-msf.org
Pharmaceutical Pricing and Reimbursement Information: ppri.oebig.at
B. Useful Links - Guidelines
Below you can find a list of useful links to national drug authorities and their guidelines.
Africa
Egypt – Egyptian Drug Authority: www.eda.mohp.gov.eg
South Africa - Medicines Control Council: www.sanctr.gov.za/YourRights/TheMedicinesControlCouncil/tabid/176/Default.aspx
Uganda – National Drug Authority: www.nda.or.ug/
Asia
China - State Food and Drug Administration, P.R.China: http://eng.sfda.gov.cn/WS03/CL0755/
India - Central Drugs Standard Control Organization: www.cdsco.nic.in
Japan - National Institute of Health Sciences, Division of Drugs: www.nihs.go.jp/drug/DrugDiv-E.html
Malaysia - ASEAN Consultative Committee for Standards and Quality: www.aseansec.org/14904.htm
Malaysia - Biro Pengawalan Farmaseutikal Kebangsaan, National Pharmaceutical Control Bureau: http://portal.bpfk.gov.my/index.cfm?menuid=50
Saudi Arabia - Saudi Food and Drug Administration: www.sfda.gov.sa/En/Drug/Topics/Regulations+-+Guidelines.htm
Singapore - Health Sciences Authority: www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation.html
South Korea - Korea Food and Drug Administration: http://eng.kfda.go.kr/index.php
Taiwan - Centre for Drug Evaluation: www.cde.org.tw/English/Pages/e-default.aspx
Thailand - Food and Drug Administration, Drug Control Division (DCD): www.fda.moph.go.th/eng/drug/index.stm
Australia and Oceania
Australia - Therapeutic Goods Administration: www.tga.gov.au/industry/pm-sgp.htm
New Zealand - New Zealand Medicines and Medical Devices Safety Authority: www.medsafe.govt.nz/regulatory/guidelines.asp
Europe
Denmark – Danish Medicines Agency: www.laegemiddelstyrelsen.dk/en
Switzerland - Swissmedic www.swissmedic.ch/index.html?lang=en
The Netherlands - College ter beoordeling van Geneesmiddelen/Medicines Evaluation Board: www.cbg-meb.nl/CBG/en/human-medicines/regulatory-affairs/legislation-guidelines/default.htm
Turkey – Ministry of Health: www.saglik.gov.tr/EN/ana-sayfa/2-0/20110906.html
Middle East
Israel - Ministry of Health: www.health.gov.il/english/
North America
Canada - Health Canada www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/bio/index-eng.php
USA - US Food and Drug Administration: www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
Central and South America
Argentina - La Administración Nacional de Medicamentos, Alimentos y Tecnología Médica: www.anmat.gov.ar/principal.asp
Brazil - Agência Nacional de Vigilância Sanitária: http://portal.anvisa.gov.br/wps/portal/anvisa/anvisa/legislacao
Mexico - Secretaría de Salud: www.portal.salud.gob.mx
Guidelines General - Related Organisations
European Directorate for the Quality of Medicines & HealthCare: www.edqm.eu/site/Quality-Assurance-Activities-Guidelines-86.html
European Medicines Agency: www.ec.europa.eu/health/documents/eudralex/index_en.htm
International Conference on Harmonisation (ICH): www.ich.org/products/guidelines.html
Organisation for Economic Co-operation and Development: www.oecd.org
Pan American Health Organisation: http://new.paho.org/
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme: www.picscheme.org/publication.php?id=4
World Health Organisation: www.who.int/en/
