The Impact Global Health R&D pipeline records the drugs, vaccines, diagnostics and other health products being developed for neglected diseases, emerging infectious diseases and women’s health, together with those that have already been approved. It exists so that funders, researchers and policymakers can see what is being worked on, and what is not. This page sets out what the pipeline covers, where the information comes from, how records are reviewed and validated, and how far the pipeline can be relied on.
1. Scope
The pipeline covers three global health areas: neglected diseases, emerging infectious diseases and women’s health. Each area has a defined set of diseases or conditions, and each disease or condition has a defined set of product areas tracked for it. The annexes list these disease and product areas, along with any restrictions or partial-inclusion criteria that apply. These choices are fixed before a review begins and are not decided record by record.
Across the pipeline, the tracked product areas are drugs, vaccines, biologics, diagnostics, microbicides, vector control products, dietary supplements and devices. Not every product area applies to every disease or condition. For example, vector control products apply only to selected neglected and emerging infectious diseases. Microbicides apply only to HIV/AIDS and to the three sexually transmitted infections tracked under women’s health. Dietary supplements and devices apply only to selected women’s health conditions.
Inclusion is based on the combination of disease or condition and product area. If a product area is not tracked for a disease or condition, it is outside the pipeline’s scope for that area, even where the work itself may be scientifically valuable. Some combinations are included only when they meet specific criteria.
The unit of record is a candidate or an approved product, not a study. Clinical trials, publications and regulatory listings are evidence about products; they are not themselves the thing catalogued. Every inclusion and exclusion below turns on whether a specific candidate or approved product exists, and on what the available evidence tells us about it.
To be included, a record must relate directly to the development, testing, approval or use of a specific candidate or approved product. This includes work that develops a new drug, vaccine, biologic, diagnostic, device or other tracked product area; tests a candidate or product in preclinical, clinical or field studies; supports regulatory approval or prequalification; or develops a new formulation, indication, dose, delivery method or use for an existing product.
The pipeline does not include work that falls outside direct product development. The main exclusions are:
- No identifiable candidate or product: Discovery or screening programmes are not included where no unique candidate, product concept or diagnostic concept has been defined. This includes target identification, biomarker discovery, and other early research that has not yet led to a specific candidate or product concept.
- Non-product development research: Behavioural, educational, health-system and service-delivery interventions are not included, as they do not involve the development or assessment of a specific candidate or approved product.
- Observational or non-interventional evidence: Candidates described only in observational or other non-interventional studies are not considered for inclusion, as these studies do not provide the type of product-development evidence used to assess pipeline records.
- Comparator and control arms: Comparator, placebo and standard-of-care arms are not recorded as separate pipeline entries. Where a study includes an intervention being developed or assessed, only that unique candidate, product or regimen is considered for inclusion.
- Nothing new being developed: Work on an already-marketed product is not included where nothing new is being developed for it. This covers safety and pharmacokinetic evidence that does not relate to a new formulation, and treatment-strategy work on the sequencing, switching or dose optimisation of products already on the market.
2. Where the information comes from
Each review uses two types of sources: common sources that are searched across all three global health areas, and targeted sources that are used for particular diseases, product areas or evidence needs. Using the same core sources in each cycle helps keep one review comparable with the next.
The common sources are ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform, the biomedical database Embase, the FIND diagnostics pipeline, World Health Organization prequalification and emergency use listings, the US Food and Drug Administration, the European Medicines Agency and Japan’s Pharmaceuticals and Medical Devices Agency.
Clinical development candidates are sourced primarily from ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. Discovery and preclinical candidates are sourced primarily from Embase, which captures relevant biomedical research that may be published or presented outside trial registries, including original research and conference abstracts. Reviews, editorials and commentary are not used to originate pipeline records.
Regulatory and prequalification sources are used to identify candidates and products that have reached approval, authorisation, prequalification or emergency use listing. FIND is used as a specialist diagnostics source, because diagnostic candidates are not always well captured in trial registries.
Targeted sources are selected for particular diseases, product areas or stages of development, rather than searched across every area in every cycle. They include product development portfolios published by organisations working in each disease area, and research grant databases maintained by major funders of global health R&D. They are sources of new information in their own right: candidates enter the pipeline from them directly, and grant databases in particular are a primary route to discovery and preclinical work that has not reached a trial registry. The difference between common and targeted sources is one of coverage, not standing.
Impact Global Health’s existing pipeline records are also used during each review. They help match new evidence against records already held, so that candidates and approved products are not counted twice under different names.
Not every source can originate a record. Some sources are used only to verify or enrich information from another source, such as mechanism of action, molecular target or route of administration. These sources do not introduce candidates or approved products on their own.
3. How a record reaches the pipeline
A record moves through a structured review process before it is added to the published pipeline. The order of the steps is deliberate: scope is set first, sources are searched, records are reviewed and checked, and only then are they reconciled into the database.
- 1Scope is fixed. This includes the diseases or conditions covered, the product areas tracked for each one, any partial-inclusion criteria, and the time period covered by the review. Setting this before searching begins helps ensure that records are assessed consistently, rather than decided case by case.Sign-off
- 2Sources are searched and relevant records are extracted. Each source is reviewed on its own terms, and the information is captured as it appears in that source before being assessed further.Sign-off
- 3Records are checked for duplicates. The same candidate often appears in more than one source, and under more than one name, so duplicates are identified before any further assessment.Sign-off
- 4Each record is classified by product name, target disease or condition, product area, R&D stage and developer, and matched against the pipeline records already held by Impact Global Health. This helps ensure that the same candidate or approved product is not counted twice under different names or from different sources.Sign-off
- 5Each record is reviewed by a subject-matter reviewer, who confirms or corrects the classification and matching, and records any changes made.Sign-off
- 6Independent quality control is carried out before records are reconciled into the database and published.
Each stage includes a sign-off point, so records are checked against the underlying source information before moving to the next stage.
The part artificial intelligence plays
Impact Global Health uses artificial intelligence to support the pipeline review process. Its role is to help retrieve records, extract structured information, match candidates and approved products across sources, add technical details and check consistency.
Artificial intelligence does not decide whether a record is in scope, and it does not validate records for publication. It is never the only source behind a record. Its outputs are treated as proposals.
Every record is reviewed by a subject-matter reviewer, and independent quality control is carried out before the record reaches the published pipeline.
4. Definitions
Candidate
A candidate is a countermeasure that is still under investigation and has not yet been approved for the disease, condition or indication recorded in the pipeline. It may be a novel entity, or an approved product that is being developed for a new indication or use and is counted in the pipeline only where that new indication or use is in scope.
Approved
A product is recorded as approved when a recognised regulator or normative body has authorised it. The core regulatory authorities are the US Food and Drug Administration, the European Medicines Agency and Japan’s Pharmaceuticals and Medical Devices Agency. Health Canada and Australia’s Therapeutic Goods Administration are used as associate authorities. The World Health Organization is progressively replacing the stringent-regulatory-authority concept with its WHO-Listed Authority framework; the Therapeutic Goods Administration reached that status in December 2025, and in-vitro diagnostics are not yet within the framework’s scope. Prequalification and emergency use listing are recorded alongside regulatory approval, and where approval is from another regulatory body, World Health Organization prequalification or emergency use listing may be used as the primary source. For diagnostics, approval status is based on what is listed by FIND and verified by Impact Global Health. Diagnostics also reach market through a wider range of routes than the authorities above, including CE marking, so a diagnostic may be legitimately on the market without appearing in any of them.
Product areas
The pipeline groups records into product areas.
Drugs
Drugs include new chemical entities, repurposed compounds, fixed-dose combinations and regimens.
Vaccines
Vaccines are biological products used for prevention. They include traditional inactivated and subunit vaccines, as well as products using newer platforms such as viral vectors or mRNA, and may involve new antigens, adjuvanted formulations or new delivery platforms.
Biologics
Biologics are non-small-molecule products used as therapeutics, such as monoclonal antibodies, recombinant proteins, and gene and cell therapies; monoclonal antibodies are always recorded as biologics and never as drugs, and vaccines used for a therapeutic indication are also recorded as biologics.
Diagnostics
Diagnostics are defined by what they detect or measure, rather than by their regulatory classification.
Microbicides
Microbicides are topical or intravaginal prevention products.
Vector control products
Vector control products include chemical products, biological products and vaccines given to animal reservoirs to help prevent transmission to people.
Dietary supplements
Dietary supplements are orally dosed products — pills, capsules, tablets or liquids — containing vitamins, minerals, botanicals, amino acids or other substances that add to dietary intake, including nutraceuticals and functional foods. Dietary supplements are included only for selected women’s health conditions.
Devices
Devices are instruments or appliances, with or without a pharmacological element, that facilitate delivery of a drug or biologic or control uterine bleeding, and are included only for selected women’s health conditions.
R&D stage
Product areas do not all move through development in the same way, so the pipeline does not force every record onto a single stage scale. Drugs, vaccines, biologics and microbicides are staged from discovery and preclinical work through Phase I, II and III to approved. Diagnostics move from early development to late development to approved. Chemical vector control products move from screening and optimisation through development to prequalification listing or regulatory approval. Biological vector control products use their own Phase I to III scale, so a Phase II biological vector control product is not equivalent to a Phase II drug. Devices in clinical development with no clinical phase listed in the registry are marked as human safety and efficacy. Where there is no usable stage information, the record is shown as unclear or not applicable rather than assigned a stage.
5. Limitations — what this pipeline is not
The pipeline is not a market analysis. It does not assess market size, demand, pricing, access, procurement or commercial viability. Its purpose is to show what is in development, or already approved, within the defined scope of the pipeline.
The pipeline is a point-in-time record. Each global health area is reviewed on its own cycle, and the published information reflects what was publicly available at the time of that review. New, changed or discontinued activity may not appear until the next review cycle.
A missing candidate or product does not necessarily mean there is no activity in that area. It may be outside the pipeline’s defined scope, not yet publicly disclosed, or not captured in the sources reviewed. Similarly, an area that is out of scope is not being judged as unimportant; it is simply not part of what this pipeline tracks.
The pipeline depends on publicly available information. Development activity that is not registered, published, listed or otherwise publicly disclosed cannot be captured. Because the pipeline includes both candidates in development and approved products, counts should be read as covering both.
6. Corrections and feedback
If a record is missing, incorrect or out of date, please let us know through the help section on the pipeline home page. This could include a missing candidate or approved product, an incorrect developer or product name, a development stage that has changed, or a product that has since been approved or discontinued.
Where possible, please include the product name, disease or condition, developer, and a public reference, such as a trial registration, publication, regulatory listing or organisational announcement. This helps us verify the information against a source.
All corrections are assessed against the same scope rules and review process as other pipeline records. If a submission falls outside the defined scope, it will not be added to the pipeline.
7. Version and review cycle
Version 1.0
| Area | Review cycle |
|---|---|
| Neglected diseases | Annual, March to June |
| Emerging infectious diseases | Annual, July to September |
| Women’s health | Annual, October to December |
These cycles describe how the pipeline is maintained; they are not a commitment to a publication date.