Q（Question）

When a physician or pharmacist requests information on the development status (clinical trial information) of an unapproved drug or new indication, what information may be provided?

A（MHLW answer）

For example, there is no objection to providing, in accordance with the conditions of the Guidelines, information from sites introduced on the MHLW website as 'Information on domestic clinical trials and clinical research' (University Hospital Medical Information Network (UMIN), Japan Pharmaceutical Information Center (JAPIC), Japan Medical Association Center for Clinical Trials (JMACCT)), information on clinical research conducted at medical institutions disclosed under the Clinical Research Act (Clinical Research Implementation Plan/Research Overview Publication System: JRCT), information published on the PMDA website regarding principal clinical trials and clinical trials conducted from a humanitarian perspective (expanded access trials), and information from ClinicalTrials.gov (https://www.clinicaltrials.gov/).

Items requiring particular attention: (4), (5), (6)

So what (meaning): For development status, only information already publicly registered in systems such as UMIN, JAPIC, JMACCT, JRCT, PMDA, or ClinicalTrials.gov may be provided. Unpublished internal development plans may not be disclosed verbally.

So why (rationale): Publicly registered information is independently verifiable and therefore satisfies the 'accurate, scientifically objective' requirement; undisclosed internal information cannot be verified and is therefore excluded.

Commentary — background, application, practical notes

Development-status information occupies a distinctive position because publicly registered information coexists with undisclosed internal development data. Physicians frequently ask manufacturers about ongoing trials in order to explore patient referral opportunities or gauge the timeline for new treatment options. The Guidelines limit permissible provision to information already published in public registries such as UMIN, JAPIC, JMACCT, JRCT, PMDA, and ClinicalTrials.gov — their public availability provides the objective verifiability needed to satisfy the scientific-evidence requirement.

A typical scenario involves a physician who specializes in the relevant disease area asking when a drug currently in Phase III trials for a new indication will become available or which sites are conducting the trial. In this case, the company may direct the physician to the registered trial's site listing, study design, and eligibility criteria on JRCT or ClinicalTrials.gov. What is not permissible is stating verbally that 'internally we are targeting a submission around 2028' — that is an undisclosed internal development timeline.

A common boundary error is supplementing public information with internal details in the guise of clarification. For example, after introducing a publicly registered trial summary, adding 'we are actually expecting interim analysis results soon' constitutes disclosure of non-public information. Similarly, while stating that a drug is 'under PMDA review' based on publicly available information is acceptable, describing the progress of that review or the content of interactions with the regulatory body is not, as those are internal details.