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Guidelines & Guidance Documents

Introduction

Main topic of this collection is Bioavailability / (in-vivo-) Bioequivalence, although GCP/GLP, dissolution/BCS, pharmacokinetics, bioanalytics and -statistics are covered to some minor extent as well.

Linked guidances/guidelines are in English, unless stated otherwise. Language codes are given according to ISO 639-1 (i.e., English en, French fr, German de, Spanish es, Danish da, Portuguese pt, Japanese ja, Chinese zh, Russian ru, Arabic ar, …)

Although links to documents are considered current with 19 Oct 2022, you should always consult websites of the respective regulatory body for any updated versions. Documents superseded by newer versions are striken through. While obsolete, previous versions are help­ful in dealing with deficiency letters issued for “old” studies. Documents published with­in the last two years are marked. Note also updates/revisionsUD and additionsnew within the last six months.
If you encounter broken links or are acquainted with any missing / updated documents please notify the webmaster.

Disclaimer

Although this Collection contains information of a legal nature, it has been developed for informational purposes only and does not constitute legal advice or opinions as to the current operative laws, regulations, or guidelines of any jurisdiction. In addition, because new standards are issued on a continuing basis, this Collection should not be considered an exhaustive source of all current applicable laws, regulations, and guidelines in the field. While reasonable efforts have been made to assure the accuracy and completeness of the information provided, researchers and other individuals should check with local authorities and/or ethics committees before starting research activities.

Abbreviations ⇐  ← 
ACCSQConsultative Committee for Standards and Quality (→ ASEAN)
AGITArbeitsgruppe Informationstechnologie (Working Group on Information Technology, Switzerland)
ANDAAbbreviated New Drug Application (→ FDA)
ANMATAdministración Nacional de Medicamentos, Alimentos y Tecnología Médica (National Administration for Medicines, Food and Medical Technology, Argentina)
ANVISAAgência Nacional de Vigilância Sanitária (National Agency for Sanitary Monitoring, Brazil)
APIActive Pharmaceutical Ingredient
ASEANAssociation of Southeast Asian Nations
BABioavailability
BCSBiopharmaceutics Classification System
BEBioequivalence
BPFKBiro Pengawalan Farmaseutikal Kebangsaan (National Pharmaceutical Control Bureau, Malaysia)
CDECenter For Drug Evaluation (Taiwan)
CDERCenter for Drug Evaluation and Research (of the → FDA)
CDSCOCentral Drugs Standard Control Organization (India)
CHMPCommittee for Medicinal Products for Human Use (of the → EMA)
CFDAChina Food & Drug Administration
CPCentralised Procedure | Concept Paper (of the → EMA)
CROContract Research Organization
CTAClinical Trial Application
CTDCommon Technical Document (according to → ICH)
DCDDrug Control Division (Thailand)
DCPDecentralised Procedure (in the → EU)
DGDADirectorate General of Drug Administration (Bangladesh)
DOCMicro$oft’s Word Format
DKMADanish Medicines Agency
EEfficacy (Topic of → ICH)
eCTDElectronic Common Technical Document (→ CTD)
EDAEgyptian Drug Authority
EDQMEuropean Directorate for the Quality of Medicines & HealthCare
EEAEuropean Economic Area
EMAEuropean Medicines Agency (formerly European Medicines Evaluation Agency – EMEA)
ERExtended Release
EUEuropean Union
EWPEfficacy Working Party (of the → EMA)
FDAFood and Drug Administration (United States)
GCPGood Clinical Practice(s)
GLPGood Laboratory Practice(s)
GLGuideline
GIFGraphics Interchange Format
GMPGood Manufacturing Practice(s)
HPFBHealth Products and Food Branch (of Health Canada)
HSAHealth Sciences Authority (Singapore)
HVDHighly Variable Drug
HVDPHighly Variable Drug Product
ICHInternational Council for Harmonisation
IMPInvestigational Medicinal Product
INDInvestigational New Drug
INVIMAInstituto Nacional de Vigilancia de Medicamentos y Alimentos (Colombia)
IRImmediate Release
IRBInstitutional Review Board
JPEGJoint Photographic Experts Group (graphics format)
JFDAJordan Food and Drug Administration
KiBKilobyte = 1,024 Bytes (filesize)
KFDA(South) Korea Food & Drug Administration
MAMarketing Authorisation (in the → EU)
MBMegabyte = 1,024KB = 1,048,576 Bytes (filesize)
MCCMedicines Control Council; since 2017 SAHPRA (South African Health Products Regulatory Authority)
MoHMinistry of Health
MRModified Release
MRPMutual Recognition Procedure (in the → EU)
NDANational Drug Authority (Uganda)
NfGNote for Guidance (of the → EMA)
NIHSNational Institute for Health Sciences (Japan)
NIMPNon Investigational Medicinal Product
OECDOrganisation for Economic Co-operation and Development
OGDOffice of Generic Drugs (of the → FDA)
PAHOPan American Health Organization
PDFAdobe’s Portable Document Format
PIC/SPharmaceutical Inspection Co-operation Scheme
PKPharmacokinetics
PtCPoints to Consider (of the → EMA)
QQuality (Topic of → ICH)
Q&AQuestions and Answers
RPReflection Paper (of the → EMA)
RTFRich Text Format
SAHPRASouth African Health Products Regulatory Authority
SFDASaudi Food & Drug Authority (Saudia Arabia)
SOPitisInflammation of a CRO in order to comply with written instructions rather than following common sense
SSSemisolid
SUPACScale-Up and Post-Approval Changes (according to → FDA)
TGATherapeutic Goods Administration (Australia)
TIFFTagged Image File Format
TİTCKTürkiye İlaç ve Tıbbi Cihaz Kurumu (Turkish Medicines and Medical Devices Agency)
TPDTherapeutic Products Directorate (of → HPFB)
WHOWorld Health Organization
ZIPCompressed file (format)

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