Useful Links


Useful Links

European Authorities and Organisations:

CMD(h)Co-Ordination Group for Mutual Recognition and Decentralised Procedures (Human)
EDQMEuropean Directorate for the Quality of Medicines & HealthCare
EMAEuropean Medicines Agency
HMAHeads of Medicines Agencies
 
AustriaBundesministerium für soziale Sicherheit, Generationen und Konsumentenschutz
BelgiumFederal Public Service (FPS) Health, Food Chain Safety and Environment
BulgariaBulgarian Drug Agency
CyprusMinistry of Health of the Republic of Cyprus
Czech RepublicState Institute for Drug Control (SUKL)
DenmarkDanish Medicines Agency
EstoniaState Agency of Medicines (SAM)
FinlandNational Agency for Medicines
FranceFrench Health Products Safety Agency
GermanyFederal Insitute for Drugs and Medical Devices (BfArM)
GermanyPaul-Ehrlich-Institut (PEI)
GreeceNational Organization for Medicines
HungaryNational Institue of Pharmacy
IcelandIcelandic Medicines Control Agency
IrelandIrish Medicines Board
ItalyMinistry of Health
LatviaState Agency of Medicines (SAM)
LiechtensteinLiechtensteinische Landesverwaltung
LithuaniaState Medicines Control Agency of Lithuania (SMCA)
LuxemburgMinistčre de la Santé
MaltaMedicines Authority
NederlandsThe Medicines Evaluation Board (MEB)
NorwayNorwegian Medicines Agency
PolandUrzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
PortugalInfarmed
RomaniaNational Medicines Agency (NMA)
SlovakiaState Institute for Drug Control (SIDC)
SloveniaMinistry of Health
SpainAgencia Espanola de Medicamentos y Productos Sanitarios
SwedenMedical Products Agency
SwitzerlandSwissmedic
TurkeyMinistry of Health
UKMedicines and Healthcare products Regulatory Agency (MHRA)


Professional Associations / Education:

AAPS (RS)American Association of Pharmaceutical Scientists (Regulatory Sciences)
AFARAssociation Francaise des Affaires Réglementaires
APVInternational Association for Pharmaceutical Technology
ARCS AustraliaAssociation of Regulatory and Clinical Scientists to the Australian Pharmaceutical Industry
BRASBelgian Regulatory Affairs Society
CAPRACanadian Association of Professional Regulatory Affairs
DGRADeutsche Gesellschaft für Regulatory Affairs e.V.
DIADrug Information Association
HURASHungarian Regulatory Affairs Society
ISPEInternational Society for Pharmaceutical Engineering
MEGRADie Mitteleuropäische Gesellschaft für Regulatory Affairs e.V.
NCRAFNorth Carolina Regulatory Affairs Forum
PDAParenteral Drug Association
RAPSRegulatory Affairs Professionals Society
SIARSocietŕ Italiana Attivitŕ Regolatorie
TOPRAThe Organisation for Professionals in Regulatory Affairs


Industry Associations:

AESGP Association of the European Self-Medication Industry
APIC Active Pharmaceutical Ingredients Committee
BIOBiotechnology Industry Organization
EBEEuropean Biopharmaceutical Enterprises
EFPIAThe European Federation of Pharmaceutical Industries and Associations
EGAEuropean Generic medicines Association
GPhAGeneric Pharmaceutical Association
IFPMAInternational Federation of Pharmaceutical Manufacturers Associations
 
ArgentiniaCámara Argentina de Especialidades Medicinales - (CAEME)
AustraliaMedicines Australia
AustriaVerband der pharmazeutischen Industrie Österreichs - (Pharmig)
BangladeshBangladesh Association of Pharmaceutical Industries - (BAPI)
BelgiumPharma.be - Association Générale de Industrie du Médicament (AGIM)
Bosnia HerzegovinaAssociation of International Pharmaceutical Manufacturers of Bosnia Herzegovina - AIPM Bosnia
BrazilAssociaçăo da Indústria Farmacęutica de Pesquisa - (INTERFARMA)
CanadaCanada Research-Based Pharmaceutical Companies - (Rx&D)
Central AmericaFederación Centroamericana de Laboratorios Farmacéuticos - (FEDEFARMA)
ChileCámara de la Industria Farmacéutica de Chile - (CIF)
China (Peoples Republic of)R&D-based Pharmaceutical Association in China - (RDPAC)
ColombiaAsociación de Fabricantes de Productos Farmacéuticos - (AFIDRO)
CroatiaCroatian Association of Research-Based Pharmaceutical Companies - (CARPC)
Czech RepublicMezinárodní asociace farmaceutických spolecností - (MAFS)
DenmarkThe Danish Association of the Pharmaceutical Industry - (LIF)
Dominican RepublicEmpresas Farmacéuticas de Investigación y Desarrollo - (EFID)
EcuadorAsociación Ecuatoriana de Industriales e Importadores de Productos Farmacéuticos - (ASOPROFAR)
FinlandPharma Industry Finland (PIF)
FranceLes Entreprises du Médicament - (LEEM)
GermanyVerband Forschender Arzneimittelhersteller e. V. - (VFA)
GermanyBundesverband der Pharmazeutischen Industrie e.V.
GermanyBAH Bundesverband der Arzneimittel-Hersteller e.V.
GermanyDeutscher Generikaverband e.V.
GermanyPro Generika e.V.
Hong KongThe Hong Kong Association of the Pharmaceutical Industry - (HKAPI)
HungaryHungarian Pharmaceutical Manufacturers Association - (MAGYOSZ)
IndiaOrganisation of Pharmaceutical Producers of India - (OPPI)
IndonesiaInternational Pharmaceutical Manufacturers Group - G.P. Farmasi - (IPMG)
IrelandIrish Pharmaceutical Healthcare Association - (IPHA)
IsraelPharma Israel - The Association of the Research-Based Pharmaceutical Companies
IsraelManufacturers Association of Israel
ItalyAssociazione delle Imprese del Farmaco - (FARMINDUSTRIA)
JapanJapan Pharmaceutical Manufacturers Association - (JPMA)
JapanJapan Generic Pharmaceutical Manufacturers Association (JGPMA)
KoreaKorean Pharmaceutical Manufacturers Association - (KPMA)
MalaysiaPharmaceutical Association of Malaysia - (PhAMA)
MexicoAsociación Mexicana de Industriales de Investigación Farmacéutia A.C. (AMIIF)
MoroccoAssociation Marrocaine de Industrie Pharmaceutique - (AMIP)
NederlandsResearch-georiënteerde Farmaceutische Industrie - NEFARMA
New ZealandResearched Medicines Industry Association of New Zealand Inc.- (RMI)
NorwayLegemiddelindustriforeningen - Norwegian Association of Pharmaceutical
PeruAsociación Nacional de Laboratorios Farmacéuticos (ALAFARPE)
PhilippinesPharmaceutical & Healthcare Association of the Philippines, Inc. - (PHAP)
PolandZwiazek Pracodawcow Innowacyjnych Firm Farmaceutcznych INFARMA (Employers Union of Innovative Pharmaceutical Companies INFARMA)
PortugalAssociaçăo Portuguesa da Indústria Farmacęutica - (APIFARMA)
Russian FederationAssociation of International Pharmaceutical Manufacturers - (AIPM)
SingaporeSingapore Association of Pharmaceutical Industries - (SAPI)
South AfricaPharmaceutical Manufacturers Association of South Africa - (PMASA)
SpainAsociación Nacional Empresarial de la Industria Farmacéutica - (FARMAINDUSTRIA)
SwedenLäkemedelsindustriföreningen - (LIF)
SwissSwiss Society of Chemical Industries - (SGCI)
TaiwanTaiwan - International Research-Based Pharmaceutical Manufacturers Association - (IRPMA)
ThailandPharmaceutical Research & Manufacturers Association - (PReMA)
TurkeyTurkish Pharmaceutical & Chemical Manufacturers Association - (IEIS)
UKThe Association of the British Pharmaceutical Industry - (ABPI)
UruguayCámara de Especialidades Farmacéuticas y Afines - (CEFA)
USAPharmaceutical Research and Manufacturers of America - (PhRMA)
VenezuelaCámara Venezolana del Medicamento -(CAVEME)


Further Authorities and Organisations:

CBER Center for Biologics Evaluation and Research (Center within FDA)
FDAU.S. Food and Drug Administration
ICHInternational Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
WHOWorld Health Organization


Others:

CDISCClinical Data Interchange Standards Consortium
ecvECV · Editio Cantor Verlag GmbH
EudraLexThe Rules Governing Medicinal Products in the European Union
EUR-LexOfficial Journal of the European Union
MedDRAMedical Dictionary for Regulatory Activities
pharmind®pharmind® - die pharmazeutische industrie

Edited by

Brigitte Friese
Barbara Jentges
Usfeya Muazzam

With special contri-
butions by
Sven Harmsen,
Susanne Keitel, Chris
Oldenhof, Klaus
Olejniczak, Henrike
Potthast, Joachim A.
Schwarz, and Barbara
Sickmueller

Special contributions
related to Switzer-
land by
Dorothee Heer and
Thomas A. Keller

With a foreword by
Susanne Keitel