Competent Authority, Ethics Committee, and Who Decides What
Part of Regulatory Affairs and the Jurisdiction Map: What Regulatory Affairs Owns.
About 6 minutes. Free, in your language, no account needed.
Why this matters
A trial needs two kinds of permission, and confusing them is the most common structural error a new regulatory professional makes.
One body asks whether the trial is scientifically and technically acceptable and whether the product may lawfully be used in that country. Another asks whether it is ethically acceptable to ask these people, in this place, to take part. They are different questions, they are usually asked by different bodies, and one cannot substitute for the other.
Getting this wrong does not produce a small error. It produces a trial that has half of the permission it needs and believes it has all of it.
The regulatory authority
The national regulatory authority authorizes the clinical trial itself. Names vary and the names matter, because writing to the wrong body wastes a statutory clock:
| Country | Authority |
|---|---|
| United States | Food and Drug Administration (FDA) |
| Japan | Pharmaceuticals and Medical Devices Agency, under MHLW |
| Canada | Health Canada |
| United Kingdom | Medicines and Healthcare products Regulatory Agency (MHRA) |
| India | Central Drugs Standard Control Organisation (CDSCO) |
| China | National Medical Products Administration (NMPA) |
| South Korea | Ministry of Food and Drug Safety (MFDS) |
| Singapore | Health Sciences Authority (HSA) |
| South Africa | South African Health Products Regulatory Authority (SAHPRA) |
| Nigeria | National Agency for Food and Drug Administration and Control (NAFDAC) |
| Kenya | Pharmacy and Poisons Board (PPB) |
| Pakistan | Drug Regulatory Authority of Pakistan (DRAP) |
| Argentina | Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) |
In the European Union the arrangement is different in a way that is easy to misread. Each member state still has its own national authority, but under Regulation 536/2014 a sponsor submits one application through a shared portal for all the member states it wants, and those states produce a single coordinated decision on the scientific part. The national authorities did not disappear. They agreed a procedure.
The ethics committee
The ethics committee, called an Institutional Review Board in the United States and an Independent Ethics Committee in much of the rest of the world, asks a different question: is it acceptable to recruit these participants, with this consent form, at this site, with these burdens and these safeguards?
An ethics committee can approve a trial the regulator has not authorized. A regulator can authorize a trial no ethics committee will approve. Both happen, and neither means the trial may proceed.
Two structural variations decide most of the practical work:
Centralized or local. Some countries have a single national ethics committee whose decision covers every site. Others require each site's own committee to review, which turns one approval into thirty. The European Union's Regulation 536/2014 divides the assessment explicitly: Part I covers the scientific and product questions and is assessed jointly by the member states concerned, while Part II covers the national and ethical questions, including consent, recruitment and compensation, and stays with each member state.
Sequenced or parallel. In some jurisdictions the regulatory authorization must come first and the ethics committee will not review without it. In others the two run simultaneously. This single fact can change a country's start-up timeline by two months, and it is the first thing to establish when planning a submission.
Who decides what, concretely
| Question | Regulatory authority | Ethics committee |
|---|---|---|
| May this product be given to humans here? | Yes | No |
| Is the protocol scientifically acceptable? | Yes | Sometimes, secondarily |
| Is the consent form adequate and in the right language? | Rarely | Yes |
| May this particular site take part? | Sometimes | Yes |
| Is the payment to participants inducement? | No | Yes |
| Must this safety report be submitted? | Yes | Usually also, on its own timeline |
| May the trial be suspended immediately? | Yes | Yes, for its own sites |
Note the last row. Both bodies can stop a trial, and they can do it independently, and neither needs the other's agreement.
In practice
A sponsor plans to open in a country where ethics review is local rather than national, with eight sites across five institutions.
The naive plan treats ethics as one task. The real work is five submissions, each to a committee with its own meeting calendar, its own submission deadline ahead of that meeting, and its own document formats. One committee meets monthly with a deadline three weeks before. Another meets every second month. A third is between chairs and has not met in ten weeks.
The regulatory lead builds the calendar backwards from the meeting dates rather than forward from today. The answer is that two sites can be ready in six weeks and one cannot be ready for fourteen, and that is not a failure of diligence. It is the committee calendar, and no amount of chasing changes it.
What the lead can do, and does, is tell the study team in week one rather than week twelve, so the enrollment forecast is built on eight sites arriving in three waves rather than all at once.
What this looks like when it goes wrong
A sponsor receives regulatory authorization in a country and instructs the site to begin screening. The site's ethics committee has approved the protocol but had asked for a revised consent form, and that revision is still in the committee's queue.
Regulatory authorization is real. Ethics approval of the protocol is real. Neither of them approves the document that participants will actually sign, and screening a participant means consenting them on a form that no committee has approved.
Every participant consented in that window has been consented on an unapproved document. That is not curable retrospectively, it is reportable, and it happened because two permissions were treated as one.
Key takeaways
- A trial needs two separate permissions: regulatory authorization for the product and the protocol, ethics approval for asking these participants to take part.
- Neither substitutes for the other, and both bodies can suspend a trial independently.
- Names of authorities differ by country and using the wrong one wastes a statutory clock.
- In the European Union one submission produces one coordinated decision on Part I, while Part II, including consent and recruitment, remains national.
- Whether ethics review is centralized or local, and whether it runs before or beside regulatory review, drives the start-up timeline more than any other single fact.