Pharmaceutical Regulatory Agencies in the World

Pharmaceutical Regulatory Agencies in the World 1

Pharmaceutical industry is a regulated industry and entire pharma world needs to follow the regulations depending on the market where they want to distribute the pharmaceutical products. You can find the list of various pharma guidelines in this article.

Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2017

image 27

1. Organizations and Standards used by pharmaceutical industry

WHO                                World Health Organization
PIC/SPharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
ICHInternational Conference on Harmonization
ISOInternational Organization for Standardization

Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems

image 28

2. Pharmaceutical regulatory agencies around the world

USAThe Food and Drug Administration (FDA)
UKMedicines and Healthcare Products Regulatory Agency (MHRA)
EuropeEuropean Medicines Agency (EMA)
IndiaCentral Drug Standards Control Organisation (CDSCO)
AustraliaTherapeutic Goods Administration (TGA)
CanadaHealth Canada (HC)
BrazilNational Health Surveillance Agency (ANVISA)
UkraineMinistry of Health (MOH)
JapanPharmaceuticals and Medical Devices Agency (PMDA)
ArgentinaNational Administration of Drugs, Food & Medical Technology
AustriaHealth & Social Affairs (HDA)
BahrainMinistry of Health (in Arabic)
BelgiumFederal Public Service (FPS) Health, Food Chain Safety and Environment
BoliviaMinistry of Health and Sports (MHS)
BotswanaMinistry of Health (MOH)
BulgariaBulgarian Drug Agency (BDA)
ChileMinistry of Health (MOH)
ChinaState Food and Drug Administration (SFDA)
ColombiaMinistry of Health (MOH)
Costa RicaMinistry of Health (MOH)
CroatiaMinistry of Health and Social Welfare (MHSW)
CubaMinistry of Public Health (MPH)
Czech RepublicState Institute for Drug Control (SIDC)
DenmarkDanish Medicines Agency (DMA)
EcuadorMinistry of Public Health (MOPH)
EgyptMinistry of Health and Population (MOHP)
EstoniaState Agency of Medicines (SAM)
FijiMinistry of Health (MOH)
FinlandNational Agency for Medicines (NAM)
FranceMinistry of Health (MOH)
GermanyMinistry of Health (MOH)
GhanaMinistry of Health(MOH)
GreeceNational Organization for Medicines (EOF)
GuamDepartment of Public Health and Social Services (DPHS)
Hong KongDepartment of Health: Pharmaceutical Services (DOH)
HungaryNational Institute for Pharmacy (NIP)
IcelandMinistry of Health & Social Security (MHSS)
IndonesiaMinistry of Health (MOH)
IrelandDepartment of Health and Children (DHC)
IsraelMinistry of Health (MOH)
ItalyMinistry of Health (MOH)
JamaicaMinistry of Health (MOH)
JordanMinistry of Health (MOH)
KenyaMinistry of Health (MOH)
LebanonMinistry of Public Health (MPH)
MalaysiaNational Pharmaceutical Control Bureau (NPCB)
MaldivesMinistry of Health and Family (MOHP)
MaltaMinistry of Health (MOH)
MauritiusMinistry of Health and Quality of Life
MexicoMinistry of Health (MOH)
MoroccoMinistry of Health (MOH)
NepalMinistry of Health and Population(MOHP)
NetherlandsMedicines Evaluation Board (MEB)
New ZealandMedsafe, Medicines and Medical Devices Safety Authority
NigeriaNational Agency for Food and Drug Administration and Control (NAFDAC)
NorwayMinistry of Health and Care Services (MHCS)
PakistanDrug Control Organisation, Ministry of Health (MOH)
PalestineMinistry of Health (MOH)
PanamaMinistry of Health (MOH)
ParaguayMinistry of Health (MOH)
PeruMinistry of Health (MOH)
PhilippinesDepartment of Health (DOH)
PolandMinistry of Health & Social Welfare (MHSW)
PortugalThe National Institute of Pharmacy and Medicines
RomaniaMinistry of Health (MOH)
RussiaPublic Health Institute (PHI)
Saudi ArabiaMinistry of Health (MOH)
SenegalMinistry of Health and Prevention (MHP)
SerbiaMinistry of Health (MOH)
SingaporeMinistry of Health (MOH)
Slovak RepublicMinistry of Health
South AfricaDepartment of Health (MOH)
South KoreaFood and Drug Administration (FDA)
SpainMinistry of Health (MOH)
Sri LankaMinistry of Healthcare and Nutrition (MHN)
SwedenMedical Products Agency (MPA)
SwitzerlandSwiss Agency for Therapeutic Products (SATP)
TaiwanDepartment of Health (DOH)
TanzaniaMinistry of Health(MOH)
ThailandMinistry of Public Health (MOPH)
TurkeyMinistry of Health (MOH)
UgandaNational Council for Science and Technology (UNCST)
United Arab EmiratesMinistry of Health (MOH)
UruguayMinistry of Public Health (MOPH)
VenezuelaMinistry of Health and Social Development
VietnamMinistry of Health (MOH)
YemenMinistry of Public Health and Population (MPHP)

Commissioning, Qualification and Validation: A GMP Approach

image 29
Scroll to Top