Under Japan’s Pharmaceuticals and Medical Devices Act (PMD Act), foreign companies that intend to manufacture drugs, quasi-drugs, active pharmaceutical ingredients (APIs) or medical devices overseas and import them into Japan must be registered with the Ministry of Health, Labor and Welfare (MHLW). This process is known as “Toroku”, or “Foreign Manufacturer Registration (FMR)”. It is a separate process from the product registration process, and is required for obtaining product registration approval. Previously, it was known as “Foreign Manufacturer Accreditation (FMA)” or “Accreditation of Foreign Manufacturers (AFM)”.
What occurs during the Foreign Manufacturer Registration process?
The FMR process involves an audit by Japanese regulatory officials from the Pharmaceutical and Medical Device Agency (PMDA). The audits are typically carried out via documentary inspections, although there have been a few on-site inspections in the past. Facilities that are responsible for manufacturing are assessed in order to confirm that the foreign manufacturer is able to participate in the product registration process. For medical devices, the following sites are required to be registered for each product:
- Design facility – the facility that maintains the design and development records for the product; the person responsible for the manufacturing operations should work here
- Main assembling plant – the facility that implements assembling (filling) processes; this facility is primarily responsible for Quality Management System (QMS) compliance or product realization
- Sterilizer – the facility that implements the sterilization process (for sterile medical device products)
- Domestic distribution center in Japan – the facility that stores the product and manages the final release of the product to the Japanese market
Applicants must submit personnel information for the manufacturing facilities to obtain FMR approval. Once the MHLW approves the FMR registration, the registration certificate is sent to the manufacturer’s Marketing Authorization Holder (MAH) by the PMDA.
What documents and materials are required for Foreign Manufacturer Registration?
Applicants must submit personnel information for the manufacturing facilities to clarify potential reasons for disqualification, such as health issues, criminal records, and revocation of previous registrations. The required materials include:
- Application for registration (Form 63-5)
- Document stating applicant is not intoxicated or under the influence of illegal substances
- Curriculum vitae of the representative of the facility to be registered
- Drawings or maps of facility premises or areas
If the PMDA requires a rare on-site inspection, only then will applicants need to submit manufacturing facility information like floor plans and production process flowcharts.
What is the difference between the Foreign Manufacturer Registration requirements and the previous Foreign Manufacturer Accreditation requirements?
On November 25, 2014, the Japanese government revised the Pharmaceutical Affairs Law (PAL) into the new “Act on Securing Quality Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics”, also known as the Pharmaceuticals and Medical Devices Act (PMD Act). With the new PMD Act, the approval process for manufacturers was changed from a license and accreditation process—known as Foreign Manufacturer Accreditation (FMA) or Accreditation of Foreign Manufacturers (AFM)—to a registration process—known as “Toroku” or Foreign Manufacturer Registration (FMR).
The major change from the license and accreditation process to the registration process is that Buildings and Facilities Regulation (BFR) compliance is no longer a prerequisite for the application. This means that applicants no longer need to submit manufacturing facility information such as floor plans and production process flowcharts for the FMR application, unless the PMDA determines that a rare on-site inspection is necessary.
Previously, the FMA/AFM license and accreditation system also required additional facilities to be registered, such as facilities involved with cell tissue or labeling and storage. With the FMR system, only the design facility, main assembling plant, sterilizer site (for sterile medical device products), and domestic distribution center need to be registered.
For more information about product registration and regulatory requirements for medical devices and pharmaceuticals in Japan, please see Medical Device Registration in Japan and Pharmaceutical and API Registration in Japan.