Clinical Trials for Medical Products in Japan

Japan clinical trialsJapan’s Ministry of Health, Labor, and Welfare (MHLW) is the main agency responsible for providing regulations for medical devices and pharmaceuticals. The Pharmaceutical Medical Devices Agency (PMDA) works alongside the MHLW to regulate the safety and quality standards of devices and drugs in Japan.

Japan ranks among the top three largest medical device and pharmaceutical markets in the world. While conducting clinical studies in Japan has its benefits, some drawbacks may include limited recognition of clinical research value, limited investigator availability, limited doctor and patient incentives, language barriers, and the relatively high costs of doing business in Japan.

Thus, clinical studies in Japan must be planned and conducted carefully. A deep understanding of the local regulations and experience with corresponding with the relevant MHLW and PMDA authorities is essential for a successful and efficient clinical trial process. Pacific Bridge Medical’s Japan office can assist you in managing your clinical trials on the ground. Our highly experienced Japan team can ensure that your Japan clinical trials are conducted in a timely and cost-effective manner so that your products can obtain registration approval sooner.

Please read more about the requirements for Japan clinical trials by clicking on the following questions.

Clinical Trials for Medical Devices in Japan

Are local clinical trials required for product registration?

In Japan, some medical device products need local clinical trials for product approval, whereas other products may be approved using foreign clinical data or via an already approved predicate device. If the device is implantable or risky, a local clinical study in Japan will almost always be required.

What are the requirements to obtain approval for clinical trial initiation?

Before conducting Japan clinical trials, the applicant must first submit a dossier containing operating procedures, protocol, Investigator’s Brochure (IB), clinical trial contracts, compensation outline, among other information. If the applicant plans on outsourcing the clinical trial, a contract must detail the agreement on duties for sponsoring and managing the trial.

Good Clinical Practices (GCP) for medical device clinical trials are enforced by the MHLW. Applicants should use PMDA’s clinical trial consulting services to help determine necessary documents, protocol, etc. for their Japan clinical trials.

What are the requirements for conducting clinical trials?

Conducting clinical trials in Japan requires compliance with certain pre-determined standards. Some of these procedures and rules are outlined below.

Institutional Review Board (IRB)

A Japanese Institutional Review Board (IRB) assesses ethical and scientific processes prior to and during clinical trials. The IRB may be established by a variety of different institutions, ranging from non-profit organizations to national universities. It is made up of at least five experts in medicine, dentistry, pharmaceutical science, healthcare, or clinical trials. The IRB members are all independent of both the medical institution supervising the trial and the founder of the IRB. The board holds meetings to review and comment on the progress of the trial. The IRB’s founder must keep records of all operating materials until receiving marketing approval and notification, or until three years after the trial is completed or terminated. 

Clinical Trial Medical Institution

In order to be considered for clinical trials, Japanese medical institutions must meet four requirements. They must be well equipped, have sufficient personnel, be capable of handling emergencies, and employ competent workers for a seamless and acceptable clinical trial. The head of the medical institution will name a record keeping manager who, similar to the IRB’s founder, will retain all materials regarding operating procedures until receiving marketing approval and notification, or until three years after the trial is completed or terminated.


A Japanese clinical trial investigator must be educated, trained, experienced, familiar with the medical device, and have sufficient time to conduct the trial. Investigators will discuss clinical trial developments to sub-investigators.

Japanese investigators are responsible for choosing clinical trial participants with appropriate health conditions, symptoms, and age. All participants must willingly consent and sign an Informed Consent Form. The trial investigator then describes and explains all medical devices to the trial participants, confirms that the participants are using the device properly, and in some cases, notifies the primary physician that their patient is using the device. They must also provide adequate medical care to those suffering from adverse events. Additionally, investigators prepare, change, correct, and inspect Case Report Forms (CRFs). Finally, upon the completion or termination of the study, investigators submit a summary of the trial to the head of the medical institution.

Informed Consent of Subjects

The informed consent forms must include the trial’s objective, design, and duration. Informed consent must be given before participating in a clinical trial. After giving consent, participants receive a signed and sealed copy of the form. Participants may only partake in a trial without consent if they face life-threatening emergencies in which current treatments are unlikely to help and the new device has a high probability of saving the patient’s life with minimal complications, or legal representatives are not immediately available to give consent.

Clinical Trials for Pharmaceuticals in Japan

Are local clinical trials required for product registration?

To register most drugs in Japan, a clinical study or Bioequivalence Evaluation (BE) study is required.

What are the requirements to obtain approval for clinical trial initiation?

Japanese clinical trials for pharmaceuticals begin with completing an Investigational New Drug (IND) application, complete with operating procedures and protocol agreement, and approval from the Institutional Review Board (IRB).

What are the requirements for conducting clinical trials?

During the trial, a case report form (CRF) must be completed using data collected from the investigation, which will be analyzed in the clinical study report. A product approval application will then be submitted and reviewed, along with the clinical trial report.

Japanese Good Clinical Practices (J-GCP)

Japan clinical trials are governed by Japanese Good Clinical Practices (J-GCP) and give local clinical site doctors much more oversight than internationally recognized standards. Japanese site heads have many responsibilities, which include signing financial contracts, ensuring site qualifications, overseeing compliance with confidentiality laws and standard operating procedures (SOPs), and determining the provisions of Investigational Medicinal Products (IMPs), among others. Furthermore, each site must have its own IRB, a provision specific to Japan.

Tips for Speeding Up Marketing Approval in Japan

  • It would be beneficial to conduct pre-clinical research on the Japanese population – or other East Asian populations – and include them in your global clinical study. Generally, when drug products begin Phase II in clinical trials overseas, companies should begin a Phase I study in Japan. Companies should also submit their New Drug Application (NDA) to the PMDA around nine months after documents are filed overseas.
  • It is also helpful to conduct Post-Market Studies (PMS) after the drug is approved. Through post-market studies, foreign companies are able to observe the use of their drug on a population larger than the population in the clinical trials.

Contact us today to discuss your clinical trial strategy and solution with our Japan clinical trials experts.

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