Regulators
Regulatory affairs is not one regulator. It is the FDA on Monday, a notified body on Wednesday and the TGA’s recall notice on Friday — and a menu that named three of them was telling you about our filing cabinet rather than about your job.
So this is the register: every authority whose decisions we watch, what each one actually controls, where its own record lives, and what we have published on it. Where we have covered an authority, its stories are here. Where we have not, it says so — we would rather be caught short than have you click into an empty page and conclude we had nothing worth reading.
Regulatory News tracks 36 regulatory authorities across the Americas, Europe, Asia-Pacific, the Middle East and Africa, and the international harmonisation bodies. 11 of them have published coverage on this site — 146 stories between 15 July 2026 and 24 September 2026 — and every entry below names what the authority actually regulates, links to its own site, and either lists that coverage or states plainly that we have none yet. Each story behind these counts is sourced to the primary record and edited by Connor Griggs. Last updated 24 September 2026.
The Americas
5 authorities · 2 with coverage
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FDAUnited States
U.S. Food and Drug Administration
Medicines, biologics, devices, diagnostics and tobacco for the US market, through CDER, CBER, CDRH and the Commissioner’s office.
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Health CanadaCanada
Health Canada — Health Products and Food Branch
Drug and device authorisations, recalls and safety communications for Canada.
2 stories on this site canada.ca
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ANVISABrazil
Agência Nacional de Vigilância Sanitária
Registration, inspection and post-market surveillance of medicines and devices in Brazil.
No coverage yet — we track it, and will report it when it acts. gov.br/anvisa
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COFEPRISMexico
Comisión Federal para la Protección contra Riesgos Sanitarios
Sanitary registration and market authorisation of health products in Mexico.
No coverage yet — we track it, and will report it when it acts. gob.mx/cofepris
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ANMATArgentina
Administración Nacional de Medicamentos, Alimentos y Tecnología Médica
Authorisation and surveillance of medicines, food and medical technology in Argentina.
No coverage yet — we track it, and will report it when it acts. argentina.gob.ar/anmat
Europe
16 authorities · 7 with coverage
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EMA & EUEuropean Union
European Medicines Agency
Scientific assessment of medicines for the EU through the CHMP, PRAC and its other committees; the Commission takes the decision.
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European CommissionEuropean Union
European Commission — DG SANTE
Grants EU marketing authorisations on the EMA’s opinion, and owns the MDR, the IVDR and EUDAMED.
8 stories on this site health.ec.europa.eu
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MHRAUnited Kingdom
Medicines and Healthcare products Regulatory Agency
UK marketing authorisations, device safety alerts, the UKCA mark and the ILAP pathway.
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Notified BodiesEuropean Union
EU notified bodies
Designated private conformity-assessment bodies that issue the CE certificates a device needs under the MDR and IVDR.
4 stories on this site ec.europa.eu
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ANSMFrance
Agence nationale de sécurité du médicament et des produits de santé
French medicine and device safety, clinical-trial authorisation and direct-to-patient safety letters.
1 story on this site ansm.sante.fr
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BfArMGermany
Bundesinstitut für Arzneimittel und Medizinprodukte
German licensing and pharmacovigilance for medicines, and device risk assessment.
No coverage yet — we track it, and will report it when it acts. bfarm.de
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Paul-Ehrlich-InstitutGermany
Paul-Ehrlich-Institut
Germany’s authority for vaccines and biomedicines, including batch release.
No coverage yet — we track it, and will report it when it acts. pei.de
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SwissmedicSwitzerland
Swiss Agency for Therapeutic Products
Authorisation and surveillance of medicines and devices in Switzerland, outside the EU system.
No coverage yet — we track it, and will report it when it acts. swissmedic.ch
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AIFAItaly
Agenzia Italiana del Farmaco
Italian medicines authorisation, pricing and reimbursement.
No coverage yet — we track it, and will report it when it acts. aifa.gov.it
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AEMPSSpain
Agencia Española de Medicamentos y Productos Sanitarios
Spanish medicines and device authorisation, inspection and supply-shortage management.
No coverage yet — we track it, and will report it when it acts. aemps.gob.es
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MEBNetherlands
Medicines Evaluation Board (CBG-MEB)
Dutch medicines assessment, and one of the EU’s most frequently chosen rapporteurs.
No coverage yet — we track it, and will report it when it acts. cbg-meb.nl
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HPRAIreland
Health Products Regulatory Authority
Irish medicines and device regulation, and inspection of a large share of EU manufacturing.
No coverage yet — we track it, and will report it when it acts. hpra.ie
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MPASweden
Läkemedelsverket (Swedish Medical Products Agency)
Swedish medicines and device approval and clinical-trial oversight.
No coverage yet — we track it, and will report it when it acts. lakemedelsverket.se
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HMAEuropean Economic Area
Heads of Medicines Agencies
The network through which the EEA’s national agencies co-ordinate mutual recognition and decentralised procedures.
1 story on this site hma.eu
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MDCGEuropean Union
Medical Device Coordination Group
Issues the guidance that settles how the MDR and IVDR are read in practice.
1 story on this site health.ec.europa.eu
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EDQMCouncil of Europe
European Directorate for the Quality of Medicines & HealthCare
Keeps the European Pharmacopoeia and issues Certificates of Suitability for active ingredients.
No coverage yet — we track it, and will report it when it acts. edqm.eu
Asia-Pacific
8 authorities · 2 with coverage
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PMDAJapan
Pharmaceuticals and Medical Devices Agency
Reviews medicines and devices for Japan; the MHLW grants the approval.
1 story on this site pmda.go.jp/english
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NMPAChina
National Medical Products Administration
Registration and inspection of drugs, devices and cosmetics for China, through the CDE.
No coverage yet — we track it, and will report it when it acts. english.nmpa.gov.cn
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MFDSSouth Korea
Ministry of Food and Drug Safety
Korean approval and surveillance of medicines, biologics and devices.
No coverage yet — we track it, and will report it when it acts. mfds.go.kr
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CDSCOIndia
Central Drugs Standard Control Organisation
Indian drug and device approval, import licensing and clinical-trial permission.
No coverage yet — we track it, and will report it when it acts. cdsco.gov.in
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TGAAustralia
Therapeutic Goods Administration
Australian registration, listing and supply suspension of therapeutic goods.
4 stories on this site tga.gov.au
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HSASingapore
Health Sciences Authority
Singapore’s regulator for medicines, devices and blood products.
No coverage yet — we track it, and will report it when it acts. hsa.gov.sg
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MedsafeNew Zealand
New Zealand Medicines and Medical Devices Safety Authority
New Zealand medicine consent, device notification and safety communication.
No coverage yet — we track it, and will report it when it acts. medsafe.govt.nz
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TFDATaiwan
Taiwan Food and Drug Administration
Taiwanese approval and inspection of medicines and devices.
No coverage yet — we track it, and will report it when it acts. fda.gov.tw/eng
Middle East & Africa
3 authorities · 0 with coverage
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SFDASaudi Arabia
Saudi Food and Drug Authority
Saudi registration and market surveillance of drugs, devices and food.
No coverage yet — we track it, and will report it when it acts. sfda.gov.sa/en
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SAHPRASouth Africa
South African Health Products Regulatory Authority
South African registration, licensing and recall of health products.
No coverage yet — we track it, and will report it when it acts. sahpra.org.za
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EDAEgypt
Egyptian Drug Authority
Egyptian medicine and device registration, and regional reliance decisions.
No coverage yet — we track it, and will report it when it acts. edaegypt.gov.eg
Global bodies
4 authorities · 0 with coverage
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WHOUnited Nations
World Health Organization
Prequalification, emergency use listing and the guidance many national regulators adopt wholesale.
No coverage yet — we track it, and will report it when it acts. who.int
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ICHInternational
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Writes the Q, S, E and M guidelines the major regulators then adopt as their own.
No coverage yet — we track it, and will report it when it acts. ich.org
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IMDRFInternational
International Medical Device Regulators Forum
Where device regulators agree common terms — adverse-event codes, SaMD definitions, audit programmes.
No coverage yet — we track it, and will report it when it acts. imdrf.org
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PIC/SInternational
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
Harmonises GMP inspection between 50-odd authorities and underwrites their mutual reliance.
No coverage yet — we track it, and will report it when it acts. picscheme.org
A note on who decides what
Three relationships in this list trip people up, so they are worth stating outright. In the European Union the EMA gives the scientific opinion and the European Commission takes the decision that binds; a CHMP positive opinion is not yet an authorisation. For devices in Europe the certificate comes from a notified body — a designated private company, not a regulator — under the eye of national competent authorities. And in Japan the PMDA reviews while the Ministry of Health, Labour and Welfare approves.
The national agencies of EU and EEA member states — ANSM, BfArM, AIFA and the rest — keep real powers of their own over national authorisations, inspections, clinical trials and safety communication, which is why they are listed separately rather than folded into the EMA. When one of them acts alone, as ANSM did in writing to 1.6 million patients about a contraceptive, it is that agency’s decision and we report it as such.
Missing one?
If an authority belongs on this list, say so: editor@regulatorynews.com. The register is deliberately broader than our coverage — it is the map of the beat, not a claim about how much of it we have walked.