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Useful Links

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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/