About Regulatory Path

What this is

Regulatory Path is a free reference for regulatory affairs and pharmacovigilance professionals working with medicines in Saudi Arabia, the GCC, the EU and the US. It sets out what each authority requires side by side — quoted from the authority's own document, with the section number and a link to the official source.

It is a knowledge project, not a business: there are no accounts, no advertising, no paid tier and nothing to buy. It is built and kept up to date as a personal interest, and it will keep growing.

It is not affiliated with, endorsed by, or an official channel of the Saudi Food and Drug Authority (SFDA), the European Commission, the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), the MHRA, the World Health Organization (WHO) or ICH.

Who

Mohammad Alghamdi — pharmacist; Scientific Office Manager at Wockhardt UK; co-founder and board member of the Digital Health Awareness Society (DHAS). LinkedIn. Views are my own; this site is not endorsed by my employer.

How the content is checked

• Comparison pages quote each regulator's own sentences, with the section number. Every excerpt is checked word for word against the official document before it is published. Which excerpt appears under which row, the at-a-glance strip and the dated notes are editorial choices.
• Variation Compass — the SFDA and EU columns reproduce the classifications in the two regulators' own tables. "Closest EU item" marks the few SFDA changes with no exact EU counterpart. FDA publishes no classification table: "Stated in FDA guidance" means the guidance names the change; "By analogy" means the category follows from the closest example under 21 CFR 314.70.
• Safety signals lists, for each active substance, the safety signals discussed at EMA's PRAC, the US FDA's safety-related labeling changes and the MHRA's Drug Safety Update articles, as each regulator published them, with links to the source.
• Local literature lists new articles in Saudi and Gulf medical and pharmacy journals from PubMed and Crossref, with the title as published, the link, and the active substances the title or abstract names. Abstracts are not reproduced.
• Radar lists new and revised documents from each authority's public index (SFDA, EMA, FDA, MHRA, ICH and WHO) and flags any document quoted on this site that has changed or is no longer online. Entries describe public listings; they are not statements by any authority.

Sources and reuse

• SFDA — guidelines, circulars and forms of the Saudi Food and Drug Authority, Drug Sector, © SFDA. Quoted in short excerpts for reference and linked to the official files on sfda.gov.sa; no SFDA file is hosted here. Not an official SFDA publication.
• European Commission / EUR-Lex — Guidelines C/2025/5045, © European Union, 2025. Reuse authorised under Commission Decision 2011/833/EU provided the source is acknowledged; only the Official Journal text is authentic.
• EMA — © European Medicines Agency; reproduction authorised provided the source is acknowledged. The EMA logo is not used.
• ICH — ICH guidelines © ICH, reproduced with acknowledgement of ICH's copyright; excerpts only, no adaptation. The ICH logo is not used.
• FDA and eCFR — U.S. Government works in the public domain. FDA has not reviewed or endorsed this site.
• MHRA / GOV.UK — contains public sector information licensed under the Open Government Licence v3.0.
• WHO — WHO Technical Report Series excerpts under CC BY-NC-SA 3.0 IGO. Excerpts selected by this site; WHO is not responsible for the selection or the comparison. The WHO name and emblem are not used.

Open-source software used: force-graph and 3d-force-graph (MIT, Vasco Asturiano), three.js (MIT), d3 (ISC); fonts Fraunces, Amiri, IBM Plex Sans Arabic and IBM Plex Mono (SIL Open Font License 1.1). Licence texts: /assets/js/LICENSES.txt, /assets/fonts/OFL.txt.

What this site will never do

No accounts, no uploads, no advertising. Visits are counted with Google Analytics only if you allow it; searches you type stay in your browser and are never sent anywhere. See the privacy note.

Not regulatory advice: the binding text is each authority's current official document. Check the source before any regulatory decision.