Regulatory divergence between regions

If the FDA and EMA have both approved a cancer drug, a smaller country should be able to approve it in three months using their reports rather than starting over.

Sometimes a progression biopsy shows exactly which drug would help, but it is licensed for another cancer and cannot be obtained. A standing pathway would fix that.

Academic first-in-human cancer trials recruit slowly because each hospital repeats ethics and regulatory review. Twenty to thirty academic phase 1 units across Europe, North America and Asia would share protocol templates, one mutually recognised review, a joint safety committee and harmonised contracts, so a trial opens at every site within weeks and rare molecular subtypes can be pooled.

Build the shared software, legal templates and data standards that let any hospital in the world join a cancer trial in weeks instead of years, the way the internet let any computer join the network.

The official information about a new cancer drug must include what patients on the trial actually reported about side-effects and daily life, not only survival curves.

Someone must legally own a drug's licence to update its label and monitor safety. A non-profit could do this for old drugs proven to work in cancer that no company wants.

Nobody keeps track of how differently the same drug is approved and dosed around the world. A public scoreboard would make the differences visible and push regulators to converge.

New ways of giving radiotherapy are adopted without the staged testing that drugs go through, and are then hard to evaluate. A defined pathway with fee waivers and clear evidence steps would bring rigour without blocking progress.

Let AI tools that improve as they learn be used under close supervision in a few hospitals, with pre-agreed rules for what changes are allowed and how they are checked.

Targeted cancer drugs often reach a country years before the test needed to select patients is approved there. Recognising other regulators' test approvals would close the gap.

Regulators are starting to use AI to read dossiers faster. If they shared one tool, it could show where their questions overlap and where they truly disagree.

Some drugs are approved for any cancer with a particular mutation. Clear rules on how many cancer types must be tested, and how to combine results across them, would make these approvals more consistent and faster.

Sometimes a treatment must be designed for a single patient. Agreeing in advance what evidence and safety checks are needed would make that fast, fair and learnable.

Some drugs work on a genetic change whatever the cancer. When one regulator approves such a label, others should adopt it rather than demanding trials per cancer type.

Statistical methods can combine information across similar rare cancers to reach an answer with fewer patients. Regulators need to say in advance when that is acceptable.

Copies of biological cancer drugs are still required to run large trials that rarely change the answer. Dropping them would cut years and tens of millions from each biosimilar.

A rare cancer drug designated 'orphan' in the US must reapply in Europe, Japan and elsewhere. Recognising each other's decisions would save small companies months.

Improving how a cell therapy is made currently risks having to repeat clinical trials. A validated computer model plus a fixed set of product measurements would let changes be approved on data alone.

Drugs given accelerated or conditional approval on surrogate endpoints have often stayed on the market for years after the confirmatory trial stalled or failed. The approval would lapse automatically if the sponsor missed agreed enrolment milestones or the readout date, unless an independent panel granted a documented extension.

Cancer AI tools are approved on old test data and then never checked again. Require every deployed tool to report its real-world performance continuously, in public.

Since 2016 England's Cancer Drugs Fund has paid a confidential discounted price for cancer drugs whose benefit is plausible but unproven, collected outcome data for two or three years, then had NICE decide for good; most drugs that entered were later recommended. Other systems could use the same managed-access deal instead of a yes-or-no at launch.

Children wait years for drugs because adult trials come first, even when the target belongs to a childhood cancer. Some drugs should start with children.

US law lets a pharmacist swap an 'interchangeable' biosimilar without asking the prescriber, but earning that label used to need costly switching studies; the FDA now says those are usually unnecessary, which should be made permanent for cancer antibodies.

Accelerated approvals rest on surrogate endpoints, and confirmatory trials take years and are sometimes never completed. Making registry enrolment with automatic outcome capture a condition of prescribing under accelerated approval would give regulators a real-world signal on benefit and toxicity within about two years, while the confirmatory trial runs.

Europe already publishes a detailed report explaining why each drug was approved. If every country did, smaller regulators could reuse the work.

No cancer AI would be approved until it has been tested on patients from at least five different hospitals in at least two countries, none of which contributed training data.

Most states require insurers to charge no more for a cancer pill than for an infusion, but the law does not reach the self-funded employer plans that cover most working Americans; a federal rule would close the gap.

Africa's new continental medicines agency could assess cancer drugs once for 55 countries. It needs oncology reviewers and a reliance rule to do it.

A drug that improves appetite and lean weight in cancer wasting is approved in Japan but almost nowhere else. Reviewing the existing evidence could widen access quickly.

Trials are inspected to check the data are real and traceable. Do the same for the hospital databases used to make regulatory decisions.

Spain lets hospitals make and use their own CAR-T under a special rule; most European countries do not. A common rule with shared outcome tracking would spread affordable academic products.

Three PD-L1 tests run on the same tumours called 46, 75 and 73 percent of them positive and agreed only 69 percent of the time. With atezolizumab withdrawn, pembrolizumab's test (22C3, combined positive score of 10) is the only one that matters, yet laboratories still run whichever kit they have. One assay, one score and a proficiency scheme would end answers that vary by postcode.

European law already lets hospitals make advanced therapies for their own patients. Pair that with a shared outcomes registry so academic CAR-Ts and similar treatments can prove themselves without a commercial licence.

Before a company runs its phase 3 cancer trial, FDA, EMA, MHRA, PMDA, Health Canada and TGA would agree the endpoints, comparator, population and statistical plan in one joint written advice letter, so a single trial can support approval everywhere. Today parallel advice is used for a handful of products a year.

Only the manufacturer can ask regulators to add a new use to a drug's label, and generic makers have no reason to. Universities and charities should be allowed to apply.

A drug approved in the US may take five years to reach a patient in Poland or never reach Nigeria. A live public tracker would show exactly where and why it is stuck.

Drugs approved on early evidence come with follow-up obligations. One of them should be finding out how tumours escape the new drug.

The FDA now asks companies to find the right dose of a cancer drug before approval. If every regulator asked the same way, companies would do it once and doses would match worldwide.

Changing how a cancer drug is made must be approved separately in over a hundred countries, which takes years and causes shortages. One approval should count for all.

A trial approved by a qualified ethics committee in one country would not need to repeat the full review in another; the second country would accept the first review and check only local issues.

Factories making living or radioactive cancer medicines are inspected separately by each country. Accepting each other's inspections would free up inspectors and speed supply.

Starting a cancer trial in ten countries means ten applications and ten ethics reviews. One shared application and a common ethics template would start trials months sooner.

Adding a new arm to an international platform trial currently needs approval in every country again. A single, pre-agreed process would let arms open in weeks.

Regulators want proof a drug works; payers want proof it is worth the price. Agreeing both requirements at once would stop drugs being approved but then not paid for.

Companies must agree separate plans for testing new cancer drugs in children with US and European regulators. A single agreed plan would get children access sooner.

Rare cancers are collectively common but each is too rare for normal trials. Link every rare cancer patient worldwide into one network with registries and trial designs built for small numbers.

When a drug is approved early, each country often demands its own follow-up study. A single shared registry would answer the safety questions faster and better.

Japan and China have often required extra local studies before accepting a global trial. Committing to accept well-designed global trials would bring drugs to Asian patients years earlier.

Contract negotiation between a hospital and a drug company often takes longer than the trial's first patient. A single pre-agreed contract and budget template, used by everyone, would cut months off opening a trial.

Companies currently reformat the same evidence for every country; a single machine-readable dossier that every regulator reads from would save years of work.

Preparing a regulatory filing requires expensive specialist software and consultants. Free, open tools would let universities and small generic firms file in more countries.

Antibody-drug conjugates built on the same linker and payload, such as deruxtecan or vedotin, share the same conjugation process, payload synthesis, impurity profile and much of the toxicology. FDA, EMA and PMDA should designate these linker-payloads as platforms so a new ADC files only antibody-specific manufacturing and toxicology data.

A cancer blood test improves every year, but a ten-year trial tests the old version. Regulators and sponsors could agree in advance how updates are validated and carried into the result.

Drugs approved on early signs of benefit are paid for as if they had proved they extend life. Pay a provisional price and adjust it, up or down, when the survival data come in.

When a regulator rejects a cancer drug, the reasons are usually secret. Publishing them everywhere would stop other countries and companies repeating the same mistakes.

Adult T-cell leukaemia has had one randomised trial, in 1998. Most T-cell lymphoma treatment rests on single-arm studies, and the diseases concentrated outside Europe and North America have the least evidence of all.

When a trusted regulator approves a cancer drug for a rare genetic target, other countries should recognise that approval within months instead of repeating years of review.

Actinium-225 can be made in particle accelerators, but the product contains a trace of a long-lived impurity that regulators have not agreed how to handle. Settle the limit and build the hubs.

A test approved to select patients for a drug in the US must go through separate approval in Europe, Japan and elsewhere, delaying the drug. Accepting each other's test approvals would fix the delay.

New cancer drugs are approved on trials of younger, fitter patients, then given mostly to older ones. Regulators should require real-world safety and benefit data in the over-75s and put it on the label.

To get an early approval, a company would set aside the money for the follow-up trial up front, so the trial cannot be quietly abandoned.

Instead of waiting months for a company to package trial results, regulators would see the data flow in during the trial and could decide within weeks of it ending.

Regulators in several countries already look at the same cancer drug dossier at the same time. Let them split the work and write one report instead of six.

Biosimilars of trastuzumab, rituximab and bevacizumab have existed for years, but poorer countries cannot assess biologics themselves and place small fragmented orders. Extending WHO prequalification, begun with trastuzumab in 2019, to every oncology biosimilar and pooling procurement would give buyers assurance and makers volume, aiming below a tenth of originator prices.