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Clinical trials

Authorisation

What is the authorisation procedure for conducting clinical trials in your jurisdiction?

When an entity intends to sponsor clinical trials or conduct clinical trials itself, it must submit a prior notification of the clinical trial plan to the minister of health, labour and welfare (Article 80-2(2) of the Pharmaceutical and Medical Device Act). The minister may instruct the Pharmaceuticals and Medical Devices Agency to review a clinical trial plan (Article 80-3 of the act). An entity cannot start a clinical trial within 30 days of submitting the notification (Article 80-2(2) of the act), unless it is an emergency. Within the 30-day period, the minister must conduct a review to assess potential danger to health (Articles 80-2(3) and 80-2(7) of the act). If necessary, the minister can instruct the applicant to amend the clinical trial plan, suspend or change the clinical trial or take other necessary measures.

Clinical practices

How robust are the standard good clinical practices followed in your jurisdiction?

Clinical trials of drugs in Japan are governed by the Ministerial Ordinance concerning the Standard for the Performance of Clinical Trials of Drugs (GCP ministerial ordinance) and the Guidance for the GCP Ministerial Ordinance published by the Ministry of Health, Labour and Welfare, which provides a commentary. These regulations are in line with the international standard (the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use).

The standard good clinical practices for medical devices and regeneration medical products are separately stipulated in each ministerial ordinance.

Reporting, disclosure and consent

What are the reporting and disclosure requirements for the results of clinical trials?

There is no statutory obligation to disclose the results of clinical trials, except for adverse effects of medicinal products. However, under the International Federation of Pharmaceutical Manufacturers and Associations’ (IFPMA) Joint Position on the Publication of Clinical Trial Results in the Scientific Literature, the registration of clinical trials and the disclosure of results are encouraged. Since the Japan Pharmaceutical Manufacturers Association (JPMA) is a member of the IFPMA, each JPMA member registers its clinical trials and discloses the results.

What are the informed consent obligations with respect to clinical trial subjects?

Before a clinical trial starts prospective trial subjects must:

  • be provided with a written explanation of the trial which they can understand; and
  • provide written consent for their participation (Article 50 of the GCP ministerial ordinance).

Insurance

What are the insurance requirements for clinical trials?

Any entity that sponsors or performs a clinical trial must make arrangements in advance for the required insurance and other necessary measures for compensation (Articles 14 and 15-9 of the GCP ministerial ordinance).

Data protection

What data protection issues should be considered when conducting clinical trials?

An entity that sponsors or conducts clinical trials, and its executives and employees, must not divulge confidential information pertaining to persons with whom they have become acquainted with in connection with a clinical trial (Article 80-2(10) of the Pharmaceutical and Medical Device Act).

An entity that sponsors a clinical trial or a medical institution that conducts a clinical trial must execute a trial contract which establishes patient confidentiality (Articles 13(1)(xii) and 15-4(1) of the GCP ministerial ordinance).

In addition to the pharmaceutical regulation, the Act on the Protection of Personal Information is also applicable.

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