Navigating the regulatory system in Japan is very challenging as Japan has its own set of regulations and customary manner of conducting business. Thus, determining the most effective and efficient regulatory strategy to obtain approval for your pharmaceutical product in Japan is key for your success in Japan.
Global Regulatory Partner GK Regulatory Team in Japan has many years of experience working within PMDA and within the Japanese regulatory environment and can help you define the appropriate regulatory strategy for your product in Japan. Our regulatory team will help you with the following:
- Identify the latest regulatory requirements related to your drug in Japan.
- Proactively identify challenges or issues that may delay the approval of your drug in Japan.
- Identify potential risks and obstacles so that you can avoid any unexpected roadblocks during the registration process.
- Propose innovative solutions and approaches to circumvent these challenges ahead of time.
- Identify the most cost-effective way to get your drug registered in Japan.
Global Regulatory Partners GK regulatory team in Japan can help you register your product in Japan by providing the following services :
1. Prepare and Submit the registration dossier for your drug to the PMDA. The submission dossier for your drug will include the following:
- Origin or backgrounds leading up to discovery and development.
- Product structure (physical, chemical, biological) nature
- Stability test data
- Toxicity data
- Pharmacologic effects
- Clinical data – New products must fulfill the requirements of the MFDS New Drug Application (NDA)
- Uses in other countries (if applicable)
- Comparison with similar domestic products (if applicable)
2. Respond to PMDA queries while they are conducting the review of your application.
ICC AND DMF REGISTRATION
Global Regulatory Partners GK can acct as your in-Country Caretaker (ICC) in Japan and provide the following services for your API :
- Preparation and submission of DMF for your API to PMDA.
- The Japanese DMF application will include the following information:
- The name of the API, excipient or other drug substance
- The manufacturing site
- The ingredients, including quantity, chemical structure, and general properties
- Manufacturing method, process controls, process validation, process development and material controls
- Quality control testing, analytical procedures, validation of analytical procedures, justification of specifications and excipients of human/animal origin information (if applicable)
- Safety data
- Non-clinical study data (primarily for new excipients)
- Test methods, including impurities and description of methods for determining structure
- Specifications, analytical procedures, validation of these procedures, batch analyses, justification of specifications and reference standards/materials
- Storage method, stability testing data, post-approval stability protocol and expiration date
- AFM or domestic manufacturing license category, number and/or date
- ICC name and address
In Japan, Good Manufacturing Practice (GMP) for drugs is referred to as Japanese GMP or J-GMP. There are other Japan-specific pharmaceutical/drug quality standards such as Good Quality Practice (GQP), Good Vigilance Practice (GVP), Good Clinical Practice (GCP), and Good Post-marketing Study Practice (GPSP).
Global Regulatory Partners GK quality team in Japan can help you to make sure that all your Japanese operations are compliant with the appropriate Japanese quality standards. Our quality team We conduct mock audits to team can help you get your manufacturing sites accredited by PMDA as well.
ACCREDITATION OF FOREIGN MANUFACTURERS (AFM)
All foreign pharmaceutical companies that want to import their drugs into Japan must be certified by the Ministry of Health Labour and Welfare (MHLW) as an Accredited Foreign Manufacturer (AFM). All foreign AFM was that used to be referred to as Foreign Manufacturer Accreditation (FMA).
To get accredited by PMDA, an (AFM) application must be prepared and submitted for review and approval to PMDA. AFM must be prepared and submitted to PMDA for each manufacturing site.
Global Regulatory Affairs GK quality team can prepare the AFM application for you and submit it to PMDA till approval. aassist in compiling and submiiting coordinating these documents for you:Applicants must submit details listed below. AFM audits are generally carried out via documentary inspections, although there have been a few on-site inspections as well.
The following is the content of AFM Application :
- Business number and its serial code (Gyosha) for each manufacturing establishment.
- Self-Declaration of Medical Condition (“Someisho”) of the senior manager representing manufacturer,personal history of the responsible person of manufacturing facility to be registered, pictures, drawings, floor plans etc. showing the building(s) within the scope of registration.
It takes approximately 3 to 4 months to get AMF approved by PMDA. Once approved AFM remains valid for five years.
MARKETING AUTHORIZATION HOLDER (MAH) IN JAPAN
Foreign pharmaceutical companies, without a local presence in Japan, and that want access Japanese market must designate first a MAH or DMAH who can handle all their local regulatory and compliance activities in Japan on their behalf. This requirement has been implemented by Ministry of Health, Labor and Welfare (MHLW) to ensure that all imported drugs in Japan are under control of local entities.
Global Regulatory Partner GK in Japan is licenced to act as your MAH or DMAH and can handle the following activities for you in Japan:
- Products importation in Japan.
- Product registration with PMDA.
- Product quality release.
- Product storage.
- Product release to distributors or other sales groups.
- Post-market surveillance
- Adverse events reporting and management.
In 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.
Global Regulatory Partner GK Clinical team in Japan can help you with the following:
- Select and work with the appropriate 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.
- Select the appropriate Clinical Trial Medical Institution
In order to be considered for clinical trials, Japanese medical institutions must be well equipped, have sufficient personnel, be capable of handling emergencies, and employ competent workers for a seamless and acceptable clinical trial.
- Work with your Investigators
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.
- Prepare the appropriate 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. 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.