Japan conditional time-limited approval: the record so far

Approval on presumed efficacy, for up to seven years

The pathway exists only for regenerative medical products, a category Japan created in 2014 together with this approval route. Drugs have a separate conditional approval scheme with its own rules, which this guide does not cover.

The legal basis is Article 23-26 of the PMD Act (the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices). After hearing the Pharmaceutical Affairs Council, the Minister may grant approval with the conditions needed for proper use and a time limit not exceeding seven years. PMDA's material lists three requirements. The product is not homogeneous in quality, its efficacy is presumed, and it is not presumed to be useless because of markedly harmful effects.

The time limit is written into the approval itself, and it can be extended. HeartSheet's original limit of five years was extended by three.

The conditions usually center on data. MHLW's guidance on the system states that, in principle, the holder must evaluate every patient treated after launch, through post-marketing surveys, as a condition of approval. MHLW's notice on handling the system is dated October 6, 2025 (Notification 1006-1).

Other conditions restrict who may use the product and where. Daiichi Sankyo's Delytact may be used only at facilities able to deal with emergencies, by neurosurgeons experienced in treating malignant glioma, and the company first supplied it only to the clinical trial sites. Sumitomo Pharma's materials for Amchepry say that its current treatment sites are all sites of its post-marketing clinical trial. Restrictions like these keep early volumes small by design.

The end point is fixed by law. Within the time limit, the holder must apply again for ordinary approval, and MHLW's material files that re-application as a new application. If no application is filed, the approval ends with the period. If the application fails, the product leaves the market, as HeartSheet did.

Read a conditional approval's expiry date and conditions before you sign a supply or capacity agreement, because the approval itself sets the earliest date your volumes can disappear.

Twelve years of results: two lost, none converted yet

The record is short enough to list in full, as far as public announcements show. We found eight products.

HeartSheet, Terumo's autologous skeletal myoblast sheets for heart failure, was approved in September 2015. Its approval carried a condition to confirm efficacy afterward, and a 2025 review in Clinical Pharmacology & Therapeutics uses the product as a case study of the system's weaknesses. Terumo applied for full approval on September 7, 2023. In July 2024 the expert panel found that the product had not met the achievement criteria set for it and that efficacy had not been shown. The Pharmaceutical Affairs Council agreed on July 24, 2024, and Terumo ended sales.

Collategene, AnGes's HGF gene therapy, was approved in March 2019. AnGes applied for full approval in May 2023 and withdrew the application in June 2024. The conditional approval then lapsed and sales ended. MHLW's reimbursement material records that two conditionally approved products were removed from the national price lists in fiscal 2024 after failing to obtain ordinary approval.

Stemirac, Nipro's cell product for spinal cord injury, was approved in December 2018 with a seven-year limit. Nipro filed for full approval on November 14, 2025, citing its comparative post-marketing survey. On October 15, 2026, the Pharmaceutical Affairs Council's committee on regenerative medical products and biological technology deliberated the application and its re-examination period, and endorsed full approval. Japanese trade press reports it as the first product to move from conditional and time-limited approval to full approval. The Minister's formal approval follows the committee's endorsement.

Five more products are inside their periods. Daiichi Sankyo's oncolytic virus Delytact was approved in June 2021 with a seven-year limit. SanBio's Akuugo followed in July 2024, and Chugai's Elevidys in May 2025, with a three-year limit according to MHLW material, which shows that seven years is a ceiling and not a default. On March 6, 2026, two iPS cell-derived products received seven-year limits: Sumitomo Pharma's Amchepry for Parkinson's disease and Cuorips's RiHEART for severe heart failure.

The pattern is clear enough to plan on. Approval came early. Confirmation has been slow, and two of the first three products did not survive it.

Size capacity and contracts for a conditionally approved product as a development program with sales attached, running to the expiry date in the approval (seven years at most), with a break clause tied to the full approval decision.

A manufacturing condition can stop shipment

The conditions are not only clinical. One recent case shows a manufacturing condition keeping an approved product off the market.

SanBio announced that Akuugo (vandefitemcel), approved on July 31, 2024 for chronic motor paralysis after traumatic brain injury, carried a condition that reflected the limited manufacturing experience at approval. SanBio had to collect quality data on commercial production, show that commercial product was comparable to the product used in the clinical trial, report the results and file a partial change based on them. Until then, the product could not be shipped.

SanBio reported its manufacturing results in stages through 2025 and filed the partial change. The expert panel agreed on October 16, 2025, and on December 9, 2025 SanBio announced that the partial change was approved and the shipment condition lifted. Akuugo was listed for reimbursement and launched in May 2026. SanBio says its plan to obtain full approval within the seven-year limit has not changed.

For a CDMO or a raw material supplier, the lesson is about comparability. A conditional approval may rest on a small clinical batch history, and the commercial process has to prove it makes the same product. Any change you make to the process during the conditional period becomes part of that proof.

If you manufacture a conditionally approved product, ask the holder for the exact wording of every approval condition that mentions quality or manufacturing, and plan your process changes around it.

GCTP inspections run through the whole period

Conditional status does not lighten the manufacturing rules. Sites are held to the GCTP Ministerial Ordinance, MHLW Ordinance No. 93 of 2014, Japan's GMP for regenerative medical products.

PMDA inspects manufacturing sites in Japan and overseas against it. A foreign manufacturer of a regenerative medical product needs accreditation from the Minister, and PMDA examines whether the site conforms to the GCTP. The accreditation guide explains the first step, and the PMDA inspection guide explains how PMDA decides between desk and on-site review for drug sites.

One document helps a site prepare. PMDA's checklist for a periodic GCTP inspection application asks first for copies of the GCTP inspection result notices and reports from the past two years, and it also asks for copies of partial change approvals and minor change notifications from the past five years.

The re-application matters most. Because MHLW treats it as a new application, expect the manufacturing and quality sections to be reviewed again, and confirm with PMDA which inspection the filing will bring. A site that changed its process during the conditional period will be explaining those changes at that point.

Keep a complete record of every process change made during the conditional period, with its comparability data, so it is ready when the holder re-applies.

What changes for suppliers and contract manufacturers

The system is being tightened at the edges. On January 14, 2026, Chuikyo, the council that sets reimbursement, agreed a policy for how conditionally approved products are reimbursed, on the premise that efficacy is properly presumed and safety confirmed at approval. MHLW's guidance makes all-patient evaluation the default condition. Both point to more evidence demanded earlier, and more scrutiny of products that cannot deliver it.

For suppliers of media, reagents and cell materials, the practical exposure is change. A supplier that changes a formulation or a source during the conditional period can push the holder into a partial change and new comparability work. The Master File guide explains how a supplier can register material data with PMDA, and PMDA also runs a consultation on the suitability of materials used to make regenerative medical products, which it set up in 2016.

For CDMOs, the exposure is time. A product whose re-application fails, or is withdrawn, leaves the market, and HeartSheet and Collategene show that this happens.

Ask every customer with a conditionally approved product for its expiry date, the date it plans to re-apply, and the change-notification period it needs from you, and write all three into the contract.

Steps for a manufacturer or supplier

Work through these when a conditionally approved product, or a candidate for one, enters your portfolio.

1. Get from the holder the approval date, the time limit and its expiry date, and the full text of the approval conditions in English translation.
2. Mark every condition that touches quality, manufacturing or supply, and agree how your site will produce the data each one requires.
3. Confirm your site's Accreditation of Foreign Manufacturers and its GCTP inspection status, and keep copies of the GCTP inspection result notices and reports from the past two years.
4. Set a change-notification period in the quality agreement long enough for the holder to assess comparability and, if needed, file a partial change before your change takes effect.
5. Keep a running file of process changes and comparability data for the re-application.
6. Ask the holder for its planned re-application date and plan for the GCTP review it will bring.
7. Put a break or review clause in supply and capacity contracts tied to the full approval decision, because the product leaves the market if full approval is refused or never sought.

For the terms you will meet in Japanese approval documents, see the side box and the glossary.