Coming soon

Ask REGTEKA AI is on its way.

Ask regulatory questions across REGTEKA intelligence.

Hear when it launches: the Regulatory Briefing

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. 15 of them have published coverage on this site — 391 stories between 15 July 2026 and 5 November 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 5 November 2026.

The Americas

5 authorities · 2 with coverage

Europe

16 authorities · 9 with coverage

Asia-Pacific

8 authorities · 3 with coverage

Middle East & Africa

3 authorities · 0 with coverage

  • 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

  • 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

  • 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 · 1 with coverage

  • WHOUnited Nations

    World Health Organization

    Prequalification, emergency use listing and the guidance many national regulators adopt wholesale.

    1 story on this site who.int

  • 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

  • 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

  • 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.