Reference

Regulatory glossary

Plain-English definitions of the acronyms and terms used across GlobalReg country profiles, comparisons, and updates.

Roles

MAH Marketing Authorisation Holder: Legal entity that owns the marketing authorisation for a medicine and bears the regulatory and pharmacovigilance obligations.
QP Qualified Person: EU/UK statutory role responsible for certifying that each batch of a medicinal product has been manufactured and tested in accordance with the marketing authorisation and GMP.
RA Regulatory Affairs: Function within a pharmaceutical company responsible for interactions with health authorities and lifecycle compliance.
RP Responsible Person: Named individual accountable to a regulator (e.g. MHRA) for pharmacovigilance, supply, and compliance obligations of a wholesale dealer's authorisation.

Procedures

CTA Clinical Trial Application: Application to a regulatory authority for permission to conduct a clinical trial.
HTA Health Technology Assessment: Systematic evaluation (typically by a national body such as NICE or HAS) of the clinical and economic value of a health technology to inform reimbursement decisions.
IRP International Recognition Procedure: MHRA pathway (effective Jan 2024) that recognises approvals from seven trusted reference regulators to enable faster UK authorisation.
MA Marketing Authorisation: The licence granted by a regulatory authority allowing a medicine to be placed on the market.
NDA New Drug Application: FDA application seeking approval to market a new pharmaceutical product in the United States.

Documents

CTD Common Technical Document: Internationally agreed format for marketing authorisation submissions, organised into 5 modules.
eCTD Electronic Common Technical Document: Electronic, navigable version of the CTD, mandatory for most major regulators including FDA, EMA and MHRA.
PIL Patient Information Leaflet: Patient-facing leaflet supplied with a medicine, written in lay language and approved by the regulator.
SmPC Summary of Product Characteristics: Authority-approved description of a medicine's properties and conditions of use, the basis for prescribing information.

Standards

GCP Good Clinical Practice: International ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials.
GDP Good Distribution Practice: Quality standard governing the wholesale distribution of medicinal products.
GMP Good Manufacturing Practice: Mandatory quality standard governing the manufacture, testing, and release of medicinal products.
GVP Good Pharmacovigilance Practice: EMA/MHRA framework of standards for the conduct of pharmacovigilance.

Authoritys

ANVISA Agência Nacional de Vigilância Sanitária: Brazilian national health surveillance agency.
CDSCO Central Drugs Standard Control Organization: Indian national regulatory authority for pharmaceuticals and medical devices.
EMA European Medicines Agency: EU agency responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
FDA Food and Drug Administration: United States federal agency regulating food, drugs, biologics, and medical devices.
Health Canada Health Canada: Canadian federal department responsible for the regulation of therapeutic products.
HSA Health Sciences Authority: Singapore's regulator for health products.
MFDS Ministry of Food and Drug Safety: South Korean regulator for food, drugs and medical devices.
MHRA Medicines and Healthcare products Regulatory Agency: United Kingdom regulator for medicines, medical devices and blood components.
MOHAP Ministry of Health and Prevention: United Arab Emirates federal authority that regulates pharmaceuticals alongside the Department of Health (Abu Dhabi) and DHA (Dubai).
NMPA National Medical Products Administration: Chinese regulator for drugs, medical devices and cosmetics.
PMDA Pharmaceuticals and Medical Devices Agency: Japanese agency responsible for the scientific review of medicines and medical devices.
SAHPRA South African Health Products Regulatory Authority: South Africa's regulator for medicines, medical devices and clinical trials.
SFDA Saudi Food and Drug Authority: Saudi Arabian regulator for food, drugs and medical devices.
Swissmedic Swiss Agency for Therapeutic Products: Swiss regulatory authority for medicinal products and medical devices.
TGA Therapeutic Goods Administration: Australian regulatory authority for therapeutic goods.

Bodys

ICH International Council for Harmonisation: Body that brings together regulatory authorities and industry to develop globally harmonised technical guidelines for pharmaceuticals.
NICE National Institute for Health and Care Excellence: England's HTA body issuing guidance on the use of new medicines and treatments.
PIC/S Pharmaceutical Inspection Co-operation Scheme: International co-operation between regulatory authorities on GMP inspections, with mutual recognition of inspection outcomes.
SMC Scottish Medicines Consortium: Scotland's HTA body advising NHS Scotland on newly licensed medicines.

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