Japan ranks among the top three largest medical device and pharmaceutical markets in the world. Conducting clinical studies in Japan may be required to get product approval there. In some instances, foreign clinical data will be accepted. In other instances, you may need to do a local clinical trial or bridging study in Japan.
Clinical studies in Japan must be planned and conducted carefully. A deep understanding of the local regulations, a strong CRO team on the ground in Japan, and experience in corresponding with the relevant Japanese regulatory authorities are essential for a successful and efficient clinical trial process. Pacific Bridge Medical’s Japan office can assist you in implementing and managing your clinical trials on the ground. We can act as your contract research organization (CRO) or help you find a qualified Japanese CRO to conduct the clinical trials in accordance with the stringent Japanese regulations. Our highly experienced Japanese clinical trial team will ensure that your clinical trials are conducted in a timely and cost-effective manner so that your products can obtain registration approval sooner.
Pacific Bridge Medical can provide these CRO services in Japan:
- Speak to the PMDA and MHLW about your clinical study
- Draft or re-do your protocol design, if needed
- Get hospital ethics approval and PMDA/MHLW approval
- Do the clinical trial
- Manage the clinical trial
- Do data and statistical analysis
- Obtain reports from each site and make sure they can be used for your product registration
- Audit clinical studies, if needed
Please read more about the clinical trial requirements and our Japan CRO services by clicking on the information below.
What is a Sakigake pathway in Japan?
To qualify for the Sakigake pathway, the premarket application must firstly be submitted or simultaneously submitted in Japan as in other countries. If a medical device, IVD, or drug is designated, the applicant will receive these benefits in Japan – 1. priority consultation with the PMDA, 2. substantive review of the pre-application, 3. faster review, and 4. someone at the PMDA will be assigned to work with you and your product. Normally, such products if required to do clinical studies in Japan are able to reduce local Japanese studies and get into the market quicker with a conditional approval – but oftentimes need to do more post market studies.
Japan Clinical Trials and CRO Services for Medical Devices
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.
How can we determine what type of medical device clinical trials are required in Japan?
To better answer this question, we recommend that you attend one or more formal PMDA consultation sessions. These PMDA consultation sessions require PBM to put together a Japanese dossier with the key facts of your product and also foreign clinical data. We will then submit this dossier and set up the PMDA meeting which our client can attend too. These formal PMDA sessions require the applicant to pay the PMDA consultation fees ranging from $5,000 to $20,000 depending on which consultation session you apply to. PBM can do this work and represent you at each consultation session.
What are the requirements to obtain approval for your medical device clinical trial application (CTA)?
Before conducting Japan clinical trials, the applicant must first submit a dossier containing operating procedures, protocol, Investigator’s Brochure (IB), clinical trial contracts, and 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 PMDA and 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 healthcare 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 sponsor of the IRB. The IRB board holds meetings to review and comment on the progress of the trial.
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.
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 with 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 notifies the primary physician that his/her 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 clinical trial report (CTR) 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 and CRO Services for Pharmaceuticals in Japan
Are local clinical trials required for product registration?
To register most drugs in Japan, a local clinical study or Bioequivalence Evaluation (BE) study is required.
How can we determine what type of pharmaceuticals clinical trials are required in Japan?
To better answer this question, we recommend that you attend one or more formal PMDA consultation sessions. These PMDA consultation sessions require PBM to put together a Japanese dossier with the key facts of your product and also foreign clinical data. We will then submit this dossier and set up the PMDA meeting which our client can attend too. These formal PMDA sessions require the applicant to pay the PMDA consultation fees ranging from $15,000 to $100,000 depending on which cosultation session you apply to. PBM can do this work and represent you at each consultation session.
What are the requirements to obtain approval for a drug or pharmaceutical clinical trial application (CTA)?
Japanese clinical trials for pharmaceuticals begin with completing an Investigational New Drug (IND) application, incorporating operating procedures and protocol agreement, the written reason to do a clinical trial, approval from the Institutional Review Board (IRB), etc.
What are the requirements for conducting pharmaceutical clinical trials in Japan?
During the clinical trial, a case report form (CRF) must be completed using data collected from the investigation, which will be analyzed in the clinical study report (CSR).
Japanese Good Clinical Practices (GCP)
Japan clinical trials are governed by Japanese Good Clinical Practices (J-GCP) and give investigational KOL doctors much more oversight than internationally recognized ICH 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 Institutional Review Board (IRB).
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 approximately 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 larger population.
Contact us today to discuss your clinical trial strategy and solution with our Japan clinical trial experts.
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