How a new medicine reaches NHS patients

A medicine that works in a clinical trial cannot be prescribed on the NHS the next day. It has to clear two separate hurdles: a licence from the medicines regulator, then a funding decision from a health technology assessment body. Only after both does it reach a prescription pad.

Rentosertib has not started any of these steps.

Step 1: a licence from the MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) decides whether a medicine may be sold in the UK. Its approval is called a marketing authorisation, often shortened to a licence. To grant one, the MHRA has to be satisfied that the medicine works, that its risks are acceptable, and that it can be made to a consistent standard.

There are two main routes.

The International Recognition Procedure lets the MHRA lean on a decision already made by a trusted regulator elsewhere, such as the European Medicines Agency, the United States Food and Drug Administration, Health Canada, Japan’s PMDA, Australia’s TGA, Swissmedic or Singapore’s HSA. Recognition A takes up to 60 days and is for straightforward cases. Recognition B takes up to 110 days and covers new active substances, orphan medicines and conditional approvals, with a pause in the clock at day 70 and advice from the Commission on Human Medicines. Around 40% of UK approvals now come through this route.

The national procedure is used when there is no prior approval to recognise. It takes 210 days of assessment time, or 150 days on a shortened route. Those are working days for the regulator, and the clock stops while the company answers questions, so the real elapsed time is longer.

Step 2: a decision on whether the NHS will pay

A licence says a medicine may be sold. It does not say the NHS will buy it. That is decided separately, and differently in each nation.

England. The National Institute for Health and Care Excellence (NICE) appraises the medicine and asks whether the health benefit it delivers is worth its price, compared with what the NHS already uses. If NICE recommends it, NHS England must make funding available within 90 days.

Scotland. The Scottish Medicines Consortium (SMC) makes its own decision, on its own timetable, and does not always reach the same answer as NICE.

Wales. The All Wales Therapeutics and Toxicology Centre (AWTTC) and the All Wales Medicines Strategy Group appraise medicines that NICE has not covered. Where NICE has published guidance, it applies in Wales.

Northern Ireland. The Department of Health endorses NICE technology appraisals, usually within a few months.

Step 3: getting the prescription

For IPF in England, antifibrotic medicines can only be started at an NHS England commissioned specialist interstitial lung disease (ILD) centre, of which there are around 23 to 24. Approval is recorded on a system called Blueteq before the first prescription. Scotland, Wales and Northern Ireland have no equivalent centre restriction, though prescribing is still through secondary care. See specialist ILD centres in the UK.

Routes that can come earlier

The Early Access to Medicines Scheme (EAMS). For life-threatening conditions with an unmet need, the MHRA can allow supply before a licence. It is a two-step scheme: first a Promising Innovative Medicine designation, which needs Phase 1 or Phase 2 safety data, then a Scientific Opinion lasting up to a year and renewable. In practice a medicine can become available 12 to 18 months before its licence. The company must be willing to supply it, usually free.

The Innovative Licensing and Access Pathway (ILAP). Relaunched in January 2025, this brings the MHRA, NICE, NHS England, the SMC and AWTTC together early in development. It has one restriction: a medicine is only eligible if its confirmatory trials have not yet started.

Scotland’s Peer Approved Clinical System Tier 2. A case-by-case route for a licensed medicine that the SMC has not recommended.

Clinical trials. For some people, a trial is the only route to an investigational medicine, and the way in is always through their own specialist team. See IPF clinical trials recruiting in the UK.

A worked example: nerandomilast

Nerandomilast shows how the two hurdles work in practice, in IPF, right now.

The MHRA granted it a marketing authorisation on 8 July 2026, the first approval anywhere in Europe. On 19 August 2026 NICE published draft guidance saying it should not be used in the NHS in England.

NICE’s reasons, in plain words:

• The company asked for the medicine to be used on its own, rather than alongside existing treatment. That meant the committee looked at a subgroup of 174 people with IPF who were not taking another antifibrotic. In that subgroup the lung function difference was not statistically significant.
• There was no head-to-head trial against the medicines the NHS already uses. Indirect comparisons showed no significant difference from nintedanib or pirfenidone.
• The economic model had problems. It treated lung function, side effects and death as independent of each other, and assumed benefit carried on after treatment stopped.
• Generic nintedanib is now available at much lower prices, which NICE ruled had to be used in the comparison. That raises the bar for anything new.
• The resulting cost per quality-adjusted life year was above the £25,000 to £35,000 range the committee said it needed to be at the lower end of.
• The list price is £3,825 per 60 tablets.

A second committee meeting was held on 12 November 2026, and final guidance is expected on 20 January 2027. Action for Pulmonary Fibrosis and the Pulmonary Fibrosis Trust both objected to the draft.

Where rentosertib would fit

Rentosertib is at the very start of this map, and not on it in the UK. Its Phase 3 trial is running in China only, with completion due in October 2029, so there is no UK or European data for the MHRA to assess and no application before it. ILAP is now closed to it because the confirmatory trial has begun, and EAMS would need UK-relevant data plus a company willing to supply the medicine free, neither of which exists. If the trial succeeds, the realistic sequence would be further trials including UK or European participants, then an MHRA application, then a NICE appraisal that would face exactly the generic nintedanib comparison that nerandomilast has just run into.