Q（Question）

May information provision activities conducted under GCP, GPSP, or GVP be considered outside the scope of these Guidelines?

A（MHLW answer）

The Guidelines target 'sales information provision activities,' and information provision activities conducted under these laws may be considered outside the scope.

Please note that such information provision activities must be conducted in full compliance with the respective relevant laws and regulations.

So what (meaning): Statutory information provision under GCP (clinical trials), GPSP (post-marketing surveillance), and GVP (safety management) falls outside the MSA Guidelines. Compliance with each underlying law still applies.

So why (rationale): The Guidelines regulate activities conducted with an expectation of promoting sales; legally mandated information provision is inherently different in character and therefore excluded from scope.

Commentary — background, application, practical notes

GCP, GPSP, and GVP are all legally mandated procedures imposed on marketing authorization holders under the pharmaceutical regulatory framework. Typical activities include transmitting safety information from clinical trials, conducting and reporting post-marketing surveillance studies, and collecting and reporting adverse reaction data to regulatory authorities. Because these activities are performed as statutory obligations rather than with any expectation of promoting sales, they fall outside the definition of 'sales information provision activities' that the Guidelines regulate.

In practice, typical scenarios include providing adverse reaction information to healthcare institutions as part of periodic safety reporting under GVP, or explaining specific post-marketing studies to attending physicians as required under GPSP. The Guidelines do not apply in such cases, but compliance with the underlying GVP and GPSP ordinances themselves continues to be required.

The boundary that is most easily misjudged is the case where the form of legally based information provision is maintained while the substance promotes the efficacy or superiority of the company's own product. For example, if a company uses an occasion for GVP safety communication to simultaneously introduce favorable trial results for its own product, that additional information provision may still fall within the Guidelines. The existence of a legal basis does not itself prove that an activity lacks a promotional character.