CRED ERP 25

Abbreviations

ADA

Anti-drug antibody

ADR

Adverse drug reaction

BMWP

Biosimilar Working Party (EMA’s working party of EU experts on biosimilars)

CHMP

Committee for Medicinal Products for Human Use (EMA’s scientific committee formed by EU experts who review and recommend marketing approval)

DNA

Deoxyribonucleic acid

EMA

European Medicines Agency

EPAR

European public assessment report

EU PAS Register

EU post-authorisation study register

FDA

Food and Drug Administration (the US medicines regulatory authority)

GMP

Good manufacturing practice

INN

International nonproprietary name

PASS

Post-authorisation safety study

PD

Pharmacodynamic(s)

PK

Pharmacokinetic(s)

PRAC

Pharmacovigilance and Risk Assessment Committee (EMA’s scientific committee formed by EU experts on safety of medicines)

PSUR

Periodic safety update report

RMP

Risk management plan

SBP

Similar biotherapeutic products (WHO term for biosimilars)

SmPC

Summary of product characteristics (the EU prescribing information)

TGA

Therapeutic Goods Administration (Australia’s medicines regulatory authority)

WHO

World Health Organisation

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