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Conditional and Time-Limited Approval

JP-unique

Japan introduced conditional approval and time-limited approval mechanisms as part of the 2019 PMD Act amendments. These allow innovative devices to access the market earlier than would be possible under standard approval, in exchange for collecting specific post-market evidence.

Conditional approval​

A conditional approval is a Shonin issued with specific conditions attached — typically a requirement to conduct post-market studies and submit the results to MHLW within a defined period.

Conditional approvals are used where:

  • Pre-market clinical evidence is limited (small patient population, rare disease, early technology)
  • The potential benefit is significant and the device addresses an unmet need
  • There is reasonable expectation that post-market evidence will confirm safety and efficacy

The MAH must meet the stated conditions within the agreed timeframe. Failure to do so can result in MHLW revoking the approval.

Time-limited approval​

A time-limited approval is a Shonin granted for a defined period (typically 5–7 years), after which the MAH must reapply with accumulated post-market evidence to obtain a full, ongoing approval.

Time-limited approvals are used for:

  • Regenerative medicine products (most common use)
  • Novel device technologies where long-term safety data is limited

At the end of the defined period, the MAH submits accumulated real-world evidence. MHLW evaluates whether to:

  • Convert to full unlimited approval
  • Extend the time-limited period
  • Revoke the approval if evidence does not support continuation

Obligations for MAHs with conditional or time-limited approvals​

  • Establish a specific post-market data collection programme meeting PMDA's expectations
  • Report interim data to MHLW at defined intervals
  • Notify MHLW of any new safety information that arises during the conditional period
  • Submit the final data package within the required timeframe

Conversion to full approval​

Once the MAH submits the required post-market data, PMDA reviews the package and MHLW makes a decision. If the data confirms safety and efficacy, the approval conditions are lifted or the time limit is removed. If the data is insufficient, MHLW may extend conditions or revoke.