serviceResearch on Understanding of Package Inserts for Pharmaceuticals Requiring Guidance

Service Description

Based on the guidance of the Ministry of Health, Labour and Welfare (*), our experienced research executives will conduct an appropriate survey.
We have many actual achievements and accumulated expertise.

*“The guidance to determine the level of understanding of package inserts for pharmaceuticals requiring guidance” announced by the director of Evaluation and Licensing Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare on May 20, 2016, and “the Q&A on the guidance to determine the level of understanding of package inserts for pharmaceuticals requiring guidance” notified as supplemental information.

Project Flow

Develop Questionnaire based on a draft of package insert from client

• A draft of package insert is to be created by the client. Based on our research experience, we will advise and make a proposal from the viewpoint of healthcare consumers.
  Develop questionnaire in line with the contents after receiving a draft.

Preliminary Research (Twice)

• Preliminary research is crucial to increase the success rate of main research.
  Based on the results of the preliminary researches, we will consult with customers about a revision of the draft package insert and questionnaire.

Main Research (Twice)

• Two researches will be conducted with 10 patients times using the draft package insert and questionnaire that are revised after the preliminary researches. If the acceptance criteria are met in two researches, the research will be completed.
  *If rejected, we will perform additional research.

Delivery of the Result

(Customer) To be Submitted as Data at the Time of Application for Approval

*It takes about 3 months to conduct the research according to the guidance.
Please consult us as soon as possible when making a request in order to allow adequate time before submission of application.