Japan Drug Registration and Approval - Overview
Japan is one of the largest pharma markets in the world.
With sales reaching $85.4 billion in 2021, Japan is the third largest pharmaceutical market in the world after the United States and China. Moreover, according to available data, Japan imported 24% of its medical needs in 2020. In other words, the role of foreign pharmaceutical companies in Japan’s pharmaceutical market is expected to continue to expand.
The Pharmaceuticals and Medical Devices Agency (PMDA), working under the Ministry of Health Labour and Welfare (MHLW), regulates medicinal products registration in Japan. The registration of medicines is done under the Pharmaceuticals and Medical Devices Act (PMD Act).
With extensive knowledge of pharmaceutical products regulation in Japan, Freyr Japan offers a wide range of Regulatory services to help expedite the approval process for foreign drugs. From Regulatory Intelligence to dossier preparation and submission, Freyr Japan provides comprehensive support to ensure a smooth and successful market entry.
Drug Classification in Japan
For the registration of medicines, it is crucial to identify the product category, as the Regulatory approval process totally depends on that. Based on PMD-Act, drugs are classified as follows:
- Prescription Drugs
- Branded drugs
- Generic drugs
- OTC Drugs
At Freyr Japan, we help you identify the Japanese drug classification, the respective Regulatory approval process, and the overall Regulatory support for drugs in Japan.
Drug Registration in Japan
Under the Pharmaceuticals and Medical Devices Act (PMD Act), the registration and approval of drugs in Japan depends on the classification of the drug product. The process for approval with the Pharmaceuticals and Medical Devices Agency (PMDA) can be summarized as follows:
To import and sell drugs in the Japanese market, an entity must be registered with the Ministry of Health, Labour, and Welfare (MHLW). All manufacturers, foreign and domestic, are required to assign a Marketing Authorization Holder (MAH) or a Designated Marketing Authorization Holder (DMAH).
To register a pharmaceutical product, a foreign manufacturer must also be accredited by the MHLW. In the PMD-Act , this process is stated as “Accreditation of Foreign Manufacturer (AFM).”
PMDA then investigates and confirms whether the manufacturing site complies with the standards of the PMDA regulations through Good Manufacturing Practice (GMP) inspections. This PMDA inspection determines the GMP conformity. Other drug quality standards include Good Quality Practice (GQP), Good Vigilance Practice (GVP), Good Clinical Practice (GCP), and Good Post-marketing Study Practice (GPSP).
An application for approval is submitted to the PMDA, which conducts a review with the help of expert committees to determine the quality, efficacy, and safety of the drugs. The documents and reports required for the application vary depending on the categories of drugs. If a foreign manufacturer of an Active Pharmaceutical Ingredient (API) does not wish to disclose its know-how in the application file, it can submit a Japanese Drug Master File (DMF) instead. In this case, it must appoint an in-country caretaker to submit the Japan DMF on its behalf. Upon reviewing the Japan DMF, the PMDA issues a DMF registration certificate.
Once the positive results of GMP conformity and Regulatory review of the application are processed by the PMDA and MHLW, the product receives approval. Approved products information is displayed on the PMDA website.
Freyr Japan supports all aspects of pharmaceutical regulation in Japan, including drug classification, selection of approval process, strategic planning, and execution of market entry.
The Accreditation Certificate (AC) issued by the PMDA is valid for five years.
Freyr Japan provides comprehensive support for post-approval lifecycle management of your products and overall regulatory affairs in Japan.
Japan Drug Registration and Approval - Freyr Expertise
- Regulatory Intelligence Support.
- Regulatory Due Diligence Support.
- Japan Drug Registration and Approval.
- Accreditation of Foreign Manufacturing (AFM).
- Designated Marketing Authorization Holder (DMAH) – Marketing Authorization Holder (MAH).
- DMF Filing Services.
- In-country Caretaking Services.
- Good Manufacturing Practices (GMP) Conformity.
- Submission Management to PMDA.
- Translation Services.
- Data Reliability Inspection.
- Reimbursement Application Submission (National Health Insurance Price Listing)
- Labeling and Artwork Support.
- Distributor Identification and Qualification.