How we source and verify regulatory data

Every claim in a country profile is graded against a strict source hierarchy. We always cite the highest-tier source available.

1. Tier 1, Primary authority publications. Statutes, regulations, official fee schedules, and guidance documents published directly by the regulatory authority (e.g. MHRA, FDA, EMA, PMDA). These are linked verbatim with the retrieval date.
2. Tier 2, Authority correspondence and press releases. Authority newsroom items, formal Q&A documents, and committee meeting minutes.
3. Tier 3, Recognised regulatory consultancies and industry trackers. Used only to triangulate Tier 1/2 sources, never as the sole basis for a claim.
4. Tier 4, Academic literature and trade press. Used for historical context only; never for fees, timelines, or procedural detail.

Where the authority is silent and Tier 3/4 sources conflict, we say so on the page in plain English rather than presenting a single figure as settled.

Every country profile was checked against the regulator's published material and carries one of three fee verification states.

1. Verified. Every pathway carrying a fee amount is traceable to a named published schedule.
2. Partially verified. Some pathways carry confirmed amounts, while others show no amount because the regulator publishes no single figure or the amount could not be confirmed.
3. Amounts withheld. No fee amount on the profile could be confirmed, so every amount was removed rather than estimated. The note on each pathway explains why.

The verification date is the day the check took place. Where a figure could not be confirmed against the regulator's own published schedule it has been removed rather than estimated, and the note on each pathway says why.

Every profile links the authority material it was built from. Where our summary and the linked authority source disagree, the authority source prevails.

Regulators rarely charge one fee. A single application can carry a screening charge on submission, a much larger charge on acceptance, and a separate charge later in the lifecycle. We show the breakdown and when each part falls due, so you can see what a rejection at screening actually costs.

We separate repeating charges by what they really are. An annual fee is charged every year. A renewal charged once every five years is not an annual fee and we never present it as one. A levy set as a percentage of sales has no single amount, so we show the basis instead.

Where the rate depends on something, such as whether the country acts as reference or concerned member state, the size of the company, or where the product is made, we show the alternative rates side by side rather than picking one and presenting it as the price.

Fifteen markets carry no fee section at all. For those regulators nothing could be confirmed against a published schedule, so we carry no figures rather than estimates. The profile still covers pathways, legal basis, requirements, timelines and unlicensed access.

Country profiles are written and reviewed by named regulatory professionals. We do not anonymise our contributors, accountability is part of the product. Where a profile has been drafted with AI assistance, the contributor named on the page has personally reviewed every line and is responsible for its accuracy.

Contributor profiles include full credentials (RPh, RP, QP, ex-MHRA, etc.) and any standing relationships with the authorities they cover.

We are actively expanding our contributor network. If you are an experienced RP, QP, RA, or QA professional interested in contributing, write to contributors@globalreg.app.

GlobalReg does not accept paid placement, sponsored content, or undisclosed referral fees from regulatory consultancies, manufacturers, or local agents. Where a contributor has an active commercial relationship with an authority or a market player they cover, that relationship is disclosed on their contributor page and they do not author content where the conflict is material.

If you believe content has been influenced by an undisclosed interest, write to editorial@globalreg.app. We will investigate and publish a correction where appropriate.

Every country profile carries a Report issue button. Corrections submitted with a citation are typically reviewed within 5 business days and acknowledged on the page's change log.

We treat regulatory accuracy as a published-record obligation, not a feature request.

• We do not provide regulatory advice. GlobalReg is a reference tool. Always verify with the relevant authority before regulatory action.
• We do not publish content scraped from authority websites without re-checking against the live source.
• We do not use machine translation for binding regulatory text. Where the authority's working language is not English, we cite the original-language source and provide a summary.