Japan’s large pharmaceutical market is still growing annually. Cancer and cardiovascular disorders are two of the leading causes of death, making drugs that treat these diseases top sellers. Other diseases that require expensive medication, such as Alzheimer’s, are also becoming increasingly common. Securing medical product approval and entering the market can be difficult, however, and complying with Japan’s strict regulations can be very time consuming for those unfamiliar with the process.
The experienced consultants at Pacific Bridge Medical can help you navigate the regulatory landscape for pharmaceutical and API registration in Japan. We will provide your medical company with the clarity and insight it requires to achieve timely and efficient product approval.
Find out more information on the regulations and requirements for drug and API registration in Japan by clicking on the questions below.
Which regulatory bodies in the Japanese government are responsible for pharmaceutical and API product registration in Japan?
The Pharmaceuticals and Medical Devices Agency (PMDA) is the agency that reviews submissions of applications for drug approval, foreign manufacturer accreditation, drug master file registration, etc.
Do pharmaceutical and API products in Japan require registration?
Yes, pharmaceutical and API products in Japan require registration prior to being marketed.
What are some examples of the different regulatory categories for pharmaceuticals?
- Ethical Generic Drugs
- Prescription Drugs
- OTC Drugs
- Class I Drug Products
- Class II Drug Products
- Class III Drug Products
- Orphan Drugs
What does the registration pathway look like for pharmaceutical products?
- Assign a Marketing Authorization Holder (MAH) or Designated Marketing Authorization Holder (DMAH)
A entity that obtains a marketing authorization license is known as a market authorization holder (MAH), and only registered MAH entities may import and sell medical products to the Japanese market. Therefore, all foreign manufacturers must designate a MAH or DMAH to manage their product registrations.For more information on MAH and DMAH, please view the Local Agent Representation for Medical Products in Japan (DMAH) page.
- Foreign Manufacturer Registration
Foreign companies that intend to manufacture drugs 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)”. For more information about the FMR system and process, please view the Foreign Manufacturer Registration in Japan page.
- Good Manufacturing Practice (GMP) Conformity Investigation
It is the investigation to determine whether manufacturing control and quality control are complied with the Ministerial Ordinance. GMP conformity of the manufacturing site is required for product approval.
- Submit a Drug Application to the PMDA
Requirements depend on the category of drug.
- The PMDA conducts a regulatory review
To evaluate the quality, efficacy, and safety of the drug, the PMDA conducts a regulatory review of characteristics including product development history, country of origin, usage in other countries, stability data, manufacturing processes, etc.
- The PMDA conducts a review of the requisites required for licensing
Foreign Manufacturer Registration (FMR), Good manufacturing practice (GMP) license
What does the general registration pathway look like for API products?
- Foreign Manufacturer Registration
Foreign companies that intend to manufacture active pharmaceutical ingredients (APIs) 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)”. For more information about the FMR system and process, please view the Foreign Manufacturer Registration in Japan page.
- Prepare the Drug Master File (DMF) application
The foreign API manufacturer needs to appoint an In-Country Caretaker (ICC) in Japan to prepare and submit a Japanese DMF. Although this system is voluntary, manufacturers are recommended to go through the registration process to best protect their intellectual property. A foreign DMF must be rewritten according to Japanese regulations and then translated into Japanese. This part of the process should be done with great precision. Otherwise, the PMDA may require several rounds of supplemental documentation requests and inquiries. Documents that should be submitted to the PMDA as part of the Japanese DMF application (all in Japanese) include information on:
- 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
- FMR or domestic manufacturing license category, number and/or date
- ICC name and address
- The ICC receives a Japanese DMF application receipt which has a specific number (J-DMF number)
- The PMDA conducts a review of the drug application and Japanese DMF
When a drug registration application refers to the J-DMF number, the PMDA will conduct a review of the Japanese DMF. The PMDA may ask further inquiries about the DMF or request supplemental information.
- The PMDA provides a DMF registration certificate (Form No. 43)
When the PMDA is satisfied with the contents of the Japanese DMF, the PMDA will provide a DMF registration certificate (Form No. 43) and a copy of the application to the registrant. A brief summary of the relevant information will also be posted on the PMDA website.
Pacific Bridge Medical offers comprehensive services to help you with drug registration, including assistance with regulatory strategy, application submission, DMAH, FMR, clinical trials, and GMP compliance.
Our consultants are also highly experienced with regulatory strategy, Japanese DMF registration, ICC, GMP compliance, and FMR for API products. Over the past several years, the PMDA has become stricter regarding requirements for DMF changes. Due to the strict regulatory requirements for DMF applications and change notifications, it is now more important than ever to have a good local ICC.
If your medical company requires assistance with drug or API registration in Japan, contact us here for a free consultation to discuss your specific needs.
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