Regulatory guide
How to check whether a drug is approved: FDA, EMA, MHRA, PMDA, NMPA and Health Canada
Which official database to open for each major regulator, what each one shows, and the common traps that make a drug look approved when it is not.
PharmaRadar360 Editorial · Published · 7 min read
Key points
- Approval is granted per regulator, per indication and per product. A US approval says nothing about Europe, and a new indication needs its own approval.
- Check the regulator’s own database, not the press release: Drugs@FDA or the Purple Book in the US, the EMA medicines database and the Union Register in the EU, MHRA Products in the UK.
- A positive CHMP opinion is a recommendation. The European Commission’s decision, normally within 67 days, is what authorises the medicine.
- Designations, accepted filings and PDUFA dates are milestones, not approvals.
Why “is it approved?” is harder than it sounds
Three things are easy to mix up. First, approval is national or regional: the FDA, the European Commission (on the advice of the European Medicines Agency), the UK’s MHRA, Japan’s health ministry (on the review of PMDA), China’s NMPA and Health Canada each decide separately. Second, approval is tied to specific indications, doses and formulations, so a medicine can be approved for one disease and still be investigational for another. Third, news flow is full of milestones that sound like approvals but are not.
The reliable answer is almost always in a free public database run by the regulator. The table below lists where to look.
| Jurisdiction | Official source | What you will find |
|---|---|---|
| United States (drugs and many therapeutic biologics) | Drugs@FDA | Approved brand-name, generic and many therapeutic biological products since 1939, updated daily; for most products approved since 1998, labels, approval letters and review documents |
| United States (biologics) | FDA Purple Book | Licensed biological products, including biosimilars and interchangeable products with their reference products |
| European Union (centrally authorised) | EMA medicines database and the Commission’s Union Register | European public assessment reports and product information from EMA; the legally binding Commission decisions, including withdrawn, suspended or refused products, in the Union Register |
| United Kingdom | MHRA Products | Summaries of Product Characteristics, patient leaflets and Public Assessment Reports, searchable by product, active substance or licence number |
| Japan | PMDA list of approved products and review reports | New drug approvals listed by approval date, with English review reports for some products |
| China | NMPA website and databases | Approval announcements and searchable product databases; the most detailed records are in Chinese |
| Canada | Health Canada Drug Product Database and Notice of Compliance database | Marketed and approved products by DIN, ingredient or company, and the dates of Notices of Compliance |
A five-step check
- Identify the active ingredient (the international non-proprietary name) and every brand name, because the same molecule can be sold under different names and by different companies in different markets.
- Search the regulator’s database for the ingredient, not only the brand name.
- Open the current label or product information and read the indication section. The approved population, line of therapy and dose are there, and they are often narrower than the headline suggests.
- Check the type and date of approval. In the US, look for Accelerated Approval; in the EU, for conditional marketing authorisation or approval under exceptional circumstances. These come with additional obligations.
- Look for later changes: new indications, restrictions, safety communications, suspensions or withdrawals.
Milestones that are not approvals
- Designations such as Fast Track, Breakthrough Therapy, PRIME or orphan designation describe development support or status, not permission to market.
- “FDA accepts the application for review” only means the filing was complete enough to review.
- A PDUFA target action date is FDA’s goal date for a decision, which can be an approval or a complete response letter.
- A positive CHMP opinion in the EU is a recommendation. The European Commission issues the binding decision, normally within 67 days.
- Approval in one country or region does not carry over to others, although some regulators run reliance or recognition routes that can shorten their own review.
When the databases disagree with the news
If a company release and a regulator database seem to disagree, the database is the record. Common reasons are timing (databases can lag a day or two behind a decision), a different indication than the one in the headline, or a different product with the same active ingredient. For the EU, check whether a medicine is still at the opinion stage: EMA publishes CHMP outcomes after each monthly meeting, before the Commission decision.
Using PharmaRadar360 alongside the official sources
The regulators directory links to more than 150 official regulatory and public-health sources by country. The drug approvals and pipeline views collect regulator records, and drug profiles such as semaglutide, tirzepatide and pembrolizumab connect approvals, trials and regulatory updates for one molecule. Use them to find the signal quickly, then confirm the detail in the regulator’s database.
Related on PharmaRadar360
Sources
- FDA: About Drugs@FDA
- FDA Purple Book
- EMA: Medicines search
- European Commission: Union Register of medicinal products
- EMA: Authorisation of medicines
- MHRA Products
- PMDA: List of approved products
- NMPA (English)
- Health Canada: Drug Product Database
This guide is general information for professionals, written from the official sources listed above. It is not legal, regulatory or medical advice. Rules change: confirm details with the regulator before relying on them.