Expedited: development dialogue and review processStill required: manufacturing and quality (CMC) evidence

1. What expedited programs for regenerative medicine are (the short version)

• United States: for regenerative medicine therapies there is the RMAT (Regenerative Medicine Advanced Therapy) designation. It was created by the 21st Century Cures Act on 13 December 2016 and combines the benefits of Fast Track and Breakthrough TherapySourced [Sources 1 and 5].
• Japan: for "regenerative medicine products", a category created by the amendment enacted in 2013 (which renamed the Pharmaceutical Affairs Act the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, the PMD Act), Article 23-26 of the PMD Act provides conditional and time-limited approval. A product is approved with a term of no more than 7 years and conditions, and the sponsor applies again within the term so that efficacy can be verifiedSourced [Sources 9 and 10].
• Europe: all ATMPs (advanced therapy medicinal products) fall under the centralised procedure, and under the EMA's PRIME scheme a rapporteur of the committee for advanced therapies (CAT) is assigned earlySourced [Sources 22 and 26].

2. Why cell and gene therapies need programs of their own

The FDA's CMC guidance of May 2026 lists the following as challenges when cell and gene therapy (CGT) products proceed by ordinary development methodsSourced [Source 7].

• Product complexity and patient-specific manufacture
• Advanced processes and cutting-edge technology
• Small patient numbers and few manufacturing runs
• Product characterisation and analytical testing
• Short shelf life, leaving a narrow time window from manufacture to administration

The Japanese notification describes the background of conditional and time-limited approval in terms closer to the material. It says that regenerative medicine products made of cells, viruses and the like are often heterogeneous, and that while proving efficacy calls for clinical trials with enough subjects, in many cases, such as rare diseases, evaluation has to rest on trials with few casesSourced [Source 9]. The text of the law itself puts, as the first requirement for conditional and time-limited approval, that the regenerative medicine product in the application is not homogeneous (Article 23-26, paragraph 1, item 1)Sourced [Source 9].

All Sourced (FDA [Source 1], MHLW notification [Source 9], EMA [Source 26]). The scope is a summary, not the full text of the provisions.

3. United States — RMAT, Fast Track, priority review, accelerated approval

The RMAT designation — what must be met, and what is gained

According to the FDA's RMAT page, a drug qualifies if it meets all three of the followingSourced [Source 1].

• It is a regenerative medicine therapy (a cell therapy, a therapeutic tissue-engineered product, a human cell or tissue product, or a combination product using them)
• It is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition
• Preliminary clinical evidence shows the potential to address an unmet medical need in that disease

The request is made together with the IND or as an amendment to the IND (the investigational new drug application), and is not granted while the IND is on clinical hold. The FDA notifies its decision within 60 calendar days of receiptSourced [Source 1]. The final guidance of 2019 describes the benefit of RMAT designation as all the benefits of Fast Track and Breakthrough Therapy (rolling review, intensive guidance from phase I, involvement of senior management and so on), and says it can be used for early discussion of surrogate or intermediate endpointsSourced [Source 5].

All Sourced (FDA, "Expedited Programs for Regenerative Medicine Therapies for Serious Conditions", February 2019 [Source 5]). The table is a summary, not the full text of the document. A designation is not approval and does not change the statistical standard for approval.

Forms of approval — accelerated approval, and ways to confirm after approval

Under FD&C Act 506(g)(7), a product given accelerated approval after RMAT designation may in some cases meet its post-approval requirements with clinical evidence other than a conventional confirmatory trial. The FDA guidance lists these meansSourced [Source 5].

• Submission of clinical evidence, clinical trials, patient registries and real-world evidence such as electronic health records
• Collection of a larger confirmatory dataset agreed in advance
• Post-approval follow-up of all patients treated before approval

The revised draft of September 2025 adds that there are "limited cases" in which observational studies where real-world data serve as the treatment and control arms, or externally controlled trials using natural history data, can fill gaps in confirmatory evidence, and lists as conditions for acceptance data reliability and relevance, comparability of populations, missing data and selection biasNot yet confirmed [Source 6]. For the basics, see our explainer on regulatory submissions and real-world data.

The 2019 final version and the 2025 revised draft

The RMAT guidance has a final version of February 2019 [Source 5], and a revised draft was published in September 2025. The draft says that, once finalised, it will replace the 2019 version, and that it rests on the commitments of PDUFA VII (the 2022 reauthorisation of the FDA user fee act)Sourced [Sources 6 and 8]. The FDA's CMC guidance of May 2026 still describes this document as a draftSourced [Source 7]. So the content of the revised draft was not settled as of this survey (October 2026)Not yet confirmed. The points that the revised draft states plainly, unlike the 2019 version, matter to materials engineers (taken up in chapter 8).

Products approved after RMAT designation (as published by the FDA)

The FDA publishes a list of products approved after RMAT designation. As of 30 September 2025 there were 14 productsSourced [Source 3].

All Sourced (FDA, "CBER RMAT Approvals", as of 30 September 2025 [Source 3]). The uses are a summary of the FDA's wording and are not an evaluation of any product's efficacy or safety. Products approved after RMAT designation include not only cell therapies but also gene therapies and tissue-engineered products. The list does not say whether a product was approved under accelerated approval.

4. Our calculation: the numbers for RMAT requests and grants

The FDA (CBER) publishes the outcomes of RMAT designation requests by fiscal year. The tally from 13 December 2016 to 30 September 2025 is as followsSourced [Source 2].

All Sourced (FDA, "Cumulative CBER RMAT Designation Requests Received by Fiscal Year" [Source 2]). The FDA notes that requests awaiting an outcome are included in the number of requests. The page was updated on 4 November 2025.

What can be said from these numbers (commentary): requests rose in fiscal 2024 and 2025, and the share granted also rose. Meanwhile, the number of approved products stays far smaller than the number of designations. A designation is only one entrance on the road to approval. The FDA states that RMAT designation is not the same as approval and does not change the safety and efficacy standards required for approval [Sources 5 and 6].

5. Japan — conditional and time-limited approval, and SAKIGAKE-designated regenerative medicine products

How conditional and time-limited approval works (PMD Act Article 23-26)

An MHLW notification (29 March 2024) sets out the requirements by quoting the lawSourced [Source 9].

• When a regenerative medicine product meets all three of the following, the Minister of Health, Labour and Welfare may approve it with conditions and a term of no more than 7 years:
  (1) the product in the application is not homogeneous; (2) it is presumed to have the efficacy, effect or performance claimed; (3) it is not presumed to have such harmful effects that it has no value in use
• The term may, where particularly necessary for proper review, be extended by up to 3 years after hearing the opinion of the Pharmaceutical Affairs Council (paragraph 2 of the same Article) [Source 10]
• The person who received approval must apply for approval again within the term (paragraph 5). If a re-application has been made but no disposition has been made within the term, the approval remains in effect until the disposition is made (paragraph 6) [Source 10]

The notification is also firm on the purpose of the system. It says that a development plan should not take conditional and time-limited approval as its final aim and should from the start include verification of efficacy, and that if, as a result of re-applying within the term and evaluating after marketing, efficacy is not confirmed, continuation of approval will not be allowedSourced [Source 9].

The course of the 8 products (published facts only)

All Sourced (PMDA lists of approved products [Sources 13 to 18], MHLW notices and meeting materials [Sources 9, 19, 20 and 21]). The terms for STEMIRAC and Delytact are the "7-year approval term" stated in the material attached to the notice of 27 June 2024 (the notice on the lapse of Collategene). Indications and clinical results are not included.

What can be read from this (commentary): of the 8 products, the published materials confirm "withdrawal of approval" and "lapse" for 2 (HeartSheet and Collategene); the others are within their term, or the outcome could not be confirmed in published materials. The published facts show that a time-limited approval is not a one-way road of "approval, then regular approval", but a system in which the arrival of the deadline can lead to the end of supply.

How quality is handled at approval and after — the notification of October 2025

In a notification dated 6 October 2025 (Iyaku-kishin-hatsu 1006 No. 1), the MHLW sorted out how conditional and time-limited approval is handledSourced [Source 10]. Its chapter 5, on quality, matters to those in materials and manufacturing.

• Regenerative medicine products too, like drugs, need to build a quality control strategy that includes critical quality attributes, critical process parameters and how they are controlled. What matters is not "ensuring quality merely by specifications" but how control from raw materials to product can consistently give the expected quality
• At the time of conditional and time-limited approval, a study of repeated runs alone may not have fully identified the sources of variation in process parameters and raw materials, so it cannot be said that a product meeting the intended quality can be made consistently; verification may therefore be needed to confirm that products of the expected quality are obtained
• The quality control strategy at approval may be provisional. At the manufacturing site, control using quality risk management is carried out, and in light of manufacturing experience accumulated through product quality review and additional knowledge of quality attributes obtained after approval, control items and process parameters that may become critical quality attributes are continually improved

On the application procedure, the notification also asks that a draft basic plan for evaluating post-marketing approval conditions be attached to the application, and that, in principle, all cases treated be included in the post-marketing evaluation [Source 10]. It adds that even if the application is withdrawn or the approval withdrawn after re-application, the study results collected within the term will be reviewed by the PMDA and published as a review report [Source 10].

SAKIGAKE designation for regenerative medicine products, and orphan designation

Apart from conditional and time-limited approval, Japan has designations that promote developmentSourced.

• The SAKIGAKE review designation system: created on 1 April 2015 for early practical use of innovative drugs, medical devices and regenerative medicine products. Where the target for an ordinary new drug is 12 months, the MHLW explained that designated products would be reviewed with a target of 6 months, using the PMDA's pre-assessment (announcement of 5 October 2017) [Source 12]
• It was then put into law by the 2019 amendment, and designation as a SAKIGAKE-designated regenerative medicine product rests on Article 77-2, paragraph 2 of the PMD Act. There are four requirements; for regenerative medicine products they are (1) a novel mechanism of action, (2) a serious disease with a major effect on life, (3) markedly high efficacy or safety for the target disease, and (4) intent and a system to develop and file early in Japan ahead of the world (or within 3 months of the first country's filing) [Source 11]
• A designation brings priority consultation, fuller pre-assessment, priority review and a concierge [Source 11]
• Designation as an orphan regenerative medicine product requires, among other things, fewer than 50,000 target patients in Japan, and the product is reviewed with priority (PMDA) [Source 27]

Among the 8 products above, the published materials record Akuugo and Amchepry as SAKIGAKE-designated and Akuugo, Elevidys, ReHeart and Amchepry as orphan regenerative medicine products [Sources 16, 17 and 19]. We have not confirmed whether the other 4 products have such designations.

6. Europe — ATMPs, PRIME, accelerated assessment

The EMA says all ATMPs are subject to the mandatory centralised procedure, with scientific evaluation by the EMASourced [Source 26]. The centre of expediting is PRIME (PRIority MEdicines), a scheme that supports development of drugs addressing unmet medical needs through early dialogueSourced [Source 22].

All Sourced (EMA, "PRIME: priority medicines" [Source 22]). For small and medium-sized enterprises and academia there is Early Entry PRIME, granted at an early stage on the basis of, for example, nonclinical proof of concept.

PRIME in numbers — ATMPs are about 27% of requests and 46% of grants

The EMA's five-year report on PRIME (data from March 2016 to June 2021) says the following about ATMPsSourced [Source 23].

• ATMPs were about 27% of requests for PRIME eligibility but had the highest success rate and made up 46% of all PRIME products. The report gives as the reason that their requests generally combined a high potential to address unmet medical need, a very specific mechanism of action and strong proof-of-concept evidence
• Of 16 PRIME products that started under accelerated assessment, 7 (44%) were ATMPs. For non-PRIME products, by contrast, only 1 ATMP (4%) started under accelerated assessment
• Among the reasons for reverting from accelerated assessment to standard review, ATMPs had many major quality concerns (specifications, manufacturing problems, process control). Switching to standard review was frequent in the PRIME analysis as well (56%)

A later EMA page gives cumulative figures as of July 2026: of requests for PRIME eligibility, 26% were granted and 67% denied (the rest out of scope, withdrawn or transferred) [Source 22]. We could not confirm figures for ATMPs alone on this updated page.

A "toolbox" for quality data — the EMA's Toolbox guidance

In April 2022 the EMA published Toolbox guidance to make it easier for PRIME and similar products to assemble quality (Module 3) data. ATMPs are coveredSourced [Source 24]. We pick out the points that bear on materials and manufacturing.

• Stability: where standard stability data are not available, an application may be possible, on scientific grounds, with data for a shorter period (for example 6 months) and in some cases from fewer than 3 batches
• Process validation: it gives as examples where a protocol may be submitted before approval instead of the final report: introduction of a new cell bank, introduction of a new reference standard, hold-time studies and transport validation. Case by case, under risk assessment, it can also be deferred to after approval
• GMP level of starting materials: the establishment of a new cell bank should follow GMP, but in exceptional cases an MCB made at an academic institution may be regarded as manufactured at an appropriate level of GMP, subject to traceability, contamination prevention, extensive characterisation, risk assessment and so on (see our explainer on cell manufacturing and cell banking)
• Comparability: ATMPs vary greatly in starting material and fall outside ICH Q5E. The principles of comparability apply, but should be read together with the separate Q&A for ATMPs (EMA/CAT/499821/2019)

A joint EMA and FDA Q&A (December 2023) sets out quality and GMP points (control strategy, process validation, stability, GMP) for PRIME and Breakthrough, but states plainly that on the FDA side it covers only products under CDER and not ATMPs under CBER [Source 25].

7. The three regions side by side

The table is an arrangement of what is Sourced (FDA [Sources 1, 5, 6 and 7], MHLW and PMDA [Sources 9 to 12], EMA [Sources 22 to 24]). "Status" is as of this article's survey (October 2026). The renewal of European conditional authorisation is a summary based on another article in this series.

8. A materials engineer's view (1): expediting moves materials and manufacturing readiness earlier

We now re-read the primary sources so far from the side of materials and process. The FDA's revised draft of September 2025, its CMC guidance of May 2026, the EMA's Toolbox and Japan's notification of October 2025 all point the same way.

The first two columns are Sourced (FDA, "CMC Flexibilities for Developing Human Cellular and Gene Therapy Products for a BLA", May 2026 [Source 7]). The right-hand column is commentary from this article. This guidance explains flexibility, and assumes prior discussion with the FDA for each product.

9. A materials engineer's view (2): a time-limited approval is a promise to supply "small quantities, at the same quality, for several years"

1. Manufacture small batches2. Test and document each lot3. Supply under controlled conditions

10. Open issues, and what is still undecided

(1) The revised RMAT guidance is not final

Besides the final version of February 2019 [Source 5], the FDA's "Expedited Programs for Regenerative Medicine Therapies for Serious Conditions" has a revised draft of September 2025 [Sources 6 and 8]. It is still a draft in the FDA document of May 2026 [Source 7]. We could not confirm a final version as of this survey (October 2026)Not yet confirmed.

(2) The FDA's published statistics look as if updates have stopped

The RMAT request and approval tables hold data as of 30 September 2025, and the page update date is November 2025 [Sources 2 and 3]. We have not confirmed requests or approvals after thatNot yet confirmed.

(3) Few products with conditional and time-limited approval have reached an "outcome"

Of the 8 products, the outcome of re-application within the term can be confirmed in published materials for two: withdrawal of approval (HeartSheet) and lapse (Collategene) [Sources 20 and 21]. Whether the products given conditional and time-limited approval in March 2026 move on to regular approval is still a matter for the futureNot yet confirmed.

(4) The extent of "flexibility" is decided in individual discussions

The documents of the FDA, EMA and MHLW are all worded as "may consider" or "can be considered", and assume prior discussion [Sources 7, 24 and 10]. How far something is accepted differs by product, process and data, and this article cannot generalise it.

(5) The PRIME figures are data from 2016 to 2021

The figures of ATMPs at about 27% of requests and 46% of grants come from the EMA five-year report (March 2016 to June 2021) [Source 23]. We could not confirm later figures for ATMPs. For GMP of ATMPs in the EU (Part IV), a concept paper for a revision aligned with Annex 1 was published in March 2025 [Source 28]. We have not confirmed the revised versionNot yet confirmed (see our explainers on GMP and on cell manufacturing and cell banking).

(6) Comparing the programs has limits

The definition of review time (starting point, treatment of clock stops), the requirements for designation and the form of approval differ by country. The tables in this article are a map and do not rank countries or compare the efficacy or safety of individual products.

11. Glossary

12. References

1. US FDA (CBER) "Regenerative Medicine Advanced Therapy Designation" (page updated 4 November 2025) https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenerative-medicine-advanced-therapy-designation
2. US FDA (CBER) "Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year" (data as of 30 September 2025) https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/cumulative-cber-regenerative-medicine-advanced-therapy-rmat-designation-requests-received-fiscal
3. US FDA (CBER) "CBER Regenerative Medicine Advanced Therapy (RMAT) Approvals" (data as of 30 September 2025) https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/cber-regenerative-medicine-advanced-therapy-rmat-approvals
4. US FDA (CBER) "CBER RMAT Designations Withdrawn after Granting or Rescinded by Fiscal Year" (data as of 30 June 2025) https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/cber-regenerative-medicine-advanced-therapy-rmat-designations-withdrawn-after-granting-or-rescinded
5. US FDA (CBER) "Expedited Programs for Regenerative Medicine Therapies for Serious Conditions - Guidance for Industry", February 2019 (PDF) https://www.fda.gov/media/120267/download
6. US FDA (CBER) "Expedited Programs for Regenerative Medicine Therapies for Serious Conditions - Draft Guidance for Industry", September 2025 (PDF) https://www.fda.gov/media/188874/download
7. US FDA (CBER) "Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application - Guidance for Industry", May 2026 (PDF) https://www.fda.gov/media/192321/download
8. Federal Register "Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry; Availability", 90 FR (25 September 2025, FR Doc. 2025-18653) https://www.govinfo.gov/content/pkg/FR-2025-09-25/pdf/2025-18653.pdf
9. Director, Medical Device Evaluation Division, Pharmaceutical Bureau, MHLW Notification Iyaku-kishin-hatsu 0329 No. 3 (29 March 2024), "On guidance for conditional and time-limited approval of regenerative medicine products and the subsequent drafting of an efficacy evaluation plan" (in Japanese) https://www.mhlw.go.jp/content/10808000/001631279.pdf
10. Director, Medical Device Evaluation Division, Pharmaceutical Bureau, MHLW Notification Iyaku-kishin-hatsu 1006 No. 1 (6 October 2025), "On the handling of conditional and time-limited approval of regenerative medicine products" (in Japanese) https://www.mhlw.go.jp/content/10808000/001631280.pdf
11. Director, Medical Device Evaluation Division, Pharmaceutical Bureau, MHLW Notification Iyaku-kishin-hatsu 0112 No. 1 (12 January 2024), "On the partial revision of the handling of designation of innovative medical devices, in vitro diagnostics and regenerative medicine products" (posted by the PMDA) (in Japanese) https://www.pmda.go.jp/files/000240376.pdf
12. MHLW press release "Starting to invite candidate products for the SAKIGAKE review designation system", 5 October 2017 (in Japanese) https://www.mhlw.go.jp/stf/houdou/0000179802.html
13. Pharmaceuticals and Medical Devices Agency (PMDA) "List of approved products, fiscal 2015 (regenerative medicine products)" (PDF) (in Japanese) https://www.pmda.go.jp/files/000228179.pdf
14. PMDA "List of approved products, fiscal 2018 (regenerative medicine products)" (PDF) (in Japanese) https://www.pmda.go.jp/files/000231456.pdf
15. PMDA "List of approved products, fiscal 2021 (regenerative medicine products)" (PDF) (in Japanese) https://www.pmda.go.jp/files/000246141.pdf
16. PMDA "List of approved products, fiscal 2024 (regenerative medicine products)" (PDF) (in Japanese) https://www.pmda.go.jp/files/000274840.pdf
17. PMDA "List of approved products, fiscal 2025 (regenerative medicine products)" (PDF) (in Japanese) https://www.pmda.go.jp/files/000280052.pdf
18. PMDA "List of approved products, fiscal 2026 (regenerative medicine products)" (PDF) (in Japanese) https://www.pmda.go.jp/files/000282058.pdf
19. Medical Device Evaluation Division, Pharmaceutical Bureau, MHLW "On the conditional and time-limited approval of three regenerative medicine products", Chuikyo General Meeting, Sou-11 Reference 2, 8 April 2026 (PDF) (in Japanese) https://www.mhlw.go.jp/content/10808000/001687611.pdf
20. Medical Device Evaluation Division, Pharmaceutical Bureau, MHLW Notification Iyaku-kishin-hatsu 0725 No. 1 (25 July 2024), "On the withdrawal of approval of regenerative medicine products given conditional and time-limited approval" (attached to Hoi-hatsu 0725 No. 4; PDF) (in Japanese) https://www.mhlw.go.jp/content/10808000/001284995.pdf
21. Medical Device Evaluation Division, Pharmaceutical Bureau, MHLW Notification Iyaku-kishin-hatsu 0627 No. 1 (27 June 2024), "On the withdrawal of an application made under Article 23-26, paragraph 5" (attached to Hoi-hatsu 0627 No. 1; includes a list of products given conditional and time-limited approval; PDF) (in Japanese) https://www.mhlw.go.jp/content/10808000/001284993.pdf
22. European Medicines Agency "PRIME: priority medicines" https://www.ema.europa.eu/en/human-regulatory-overview/research-development/prime-priority-medicines
23. European Medicines Agency "PRIME: Analysis of the first 5 years' experience", 2022 (PDF) https://www.ema.europa.eu/system/files/documents/report/2022-03_prime_5_years_report_updated_2022-04-05-en.pdf
24. European Medicines Agency "Toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME and certain marketing authorisation applications targeting an unmet medical need", April 2022 (EMA/CHMP/BWP/QWP/IWG/694114/2019, PDF) https://www.ema.europa.eu/en/documents/scientific-guideline/toolbox-guidance-scientific-elements-and-regulatory-tools-support-quality-data-packages-prime-and-certain-marketing-authorisation-applications-targeting-unmet-medical-need_en.pdf
25. EMA / US FDA "EMA-FDA joint Q&As on Quality and GMP aspects of PRIME/Breakthrough therapy applications", 4 December 2023 (EMA/CHMP/531552/2023, PDF) https://www.ema.europa.eu/en/documents/other/ema-fda-joint-qas-quality-gmp-aspects-prime-breakthrough-therapy-applications_en.pdf
26. European Medicines Agency "Advanced therapies: marketing authorisation" https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/advanced-therapies-marketing-authorisation
27. PMDA "List of approved products, fiscal 2025 (new regenerative medicine products)" page (includes an explanation of orphan regenerative medicine products) (in Japanese) https://www.pmda.go.jp/review-services/drug-reviews/review-information/ctp/0017.html
28. European Medicines Agency "Concept paper on the revision of Part IV Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products", 11 March 2025 (EMA/INS/GMP/48771/2025, PDF) https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-part-iv-guidelines-good-manufacturing-practice-specific-advanced-therapy-medicinal-products_en.pdf

13. Claim-to-source audit

Last updated 1 October 2026. Sources are limited to primary material (published material and guidance from the FDA and EMA, MHLW notifications and meeting materials, PMDA lists of approved products, and the Federal Register). Because the article includes arrangements of the programs and readings from the materials and manufacturing side, those are marked as Commentary and kept separate from sourced fact. The September 2025 revised draft of the RMAT guidance is not final, and the FDA's RMAT statistics are data as of 30 September 2025. The EMA's PRIME figures for ATMPs cover 2016 to 2021. Review time and designation requirements are defined differently in each country, so nothing here ranks countries. Market-size and share estimates are not used. This article explains approval programs and does not evaluate the efficacy or safety of individual products, nor is it medical advice. Figs. 1 to 4 are vector drawings, the hero image and Fig. 5 are AI-generated, and none of them shows an actual application document, review record or physical product.