Drug Approval Process in Japan

Japan is one of the world's biggest pharmaceutical markets, making the development and approval of new drugs in Japan a top priority for pharmaceutical companies. Understanding the specific requirements and processes for drug submissions and approvals in Japan is crucial for global teams collaborating with Japanese teams and colleagues.

This article aims to present Japan-specific submission requirements and the review/approval process of the Japanese health authority, PMDA (Pharmaceuticals and Medical Devices Agency), with a focus on requirements that may differ from global processes.

The drug approval process in Japan is less complex and easy when compared to some other countries beyond the language barriers. In addition to regulatory considerations, the PMDA offers sponsors consultation to assist them in understanding the prerequisites and the detailed procedure for drug approval. As a result of this positive change, many manufacturers choose to register and sell their medicines in Japan.

The J-NDA (Japan New Drug Application) submission and review/approval processes share similarities with those of the FDA (Food and Drug Administration) and EMA (European Medicines Agency), but there are important differences to note. One key difference is the mandatory submission of key results for the Japanese population when Japan participates in global or regional studies. This requirement demands substantial programming support.

Like the FDA and EMA, programming involvement is essential for creating the CSR (Clinical Study Report) and CTD (Common Technical Document) for a Japan submission. However, pooling adverse events from multiple studies may require additional programming support due to the inclusion of different indications, necessitating familiarity with PMDA's requirements.

The review time after filing a J-NDA is comparable to that of the US and EU, with a standard filing taking 12 months and "Orphan Drug Designation" taking 9 months. Throughout the review process, two significant periods of PMDA questions occur. The first round of questions arises after the Mendan meeting (a face-to-face meeting with PMDA approximately 2-3 months after filing), while the second round occurs after the GCP (Good Clinical Practice) compliance check by PMDA inspectors but before the Expert Review meeting.

PMDA may travel to sites in other countries for GCP inspections. Questions received during the first period are generally of a general nature, while those in the second period require substantial programming involvement, necessitating careful planning.

To gain market approval for drugs and medical devices, foreign manufacturers need to fulfill the following criteria:

• A foreign manufacturer is an individual overseas company that intends to manufacture drugs, quasi-drugs, cosmetics, or medical devices and import them into Japan.
• Foreign manufacturers need to obtain a Foreign Manufacturer Accreditation (FMA) from the Ministry of Health, Labour, and Welfare to market their products in Japan.

• For foreign pharmaceutical manufacturers, It is possible to apply for market approval directly under their name.
• Along with other necessary procedures, foreign manufacturers need to perform clinical studies to demonstrate the quality, efficacy, and safety of the drugs they intend to export to Japan.
• Fee for New Accreditation for Foreign Manufacturers

• PMDA is the agency that reviews submissions of applications for drug approval, foreign manufacturer accreditation (FMA), drug master file (DMF) registration, etc
• PMDA (Pharmaceuticals and Medical Devices Agency) is a Japanese regulatory agency, working together with the Ministry of Health, Labour, and Welfare.
• Its obligation is to protect public health by assuring the safety, efficacy, and quality of pharmaceuticals and medical devices.

When marketing a drug, it is necessary to obtain approval for each product by receiving examinations on both its efficacy and safety.

• Only a MAH license holder can submit an approval application for a product.
• To obtain product approval, the manufacturer in Japan needs to be licensed. For a foreign manufacturer, a Foreign Manufacturer Accredited Certificate (FMA) is required.
• The application is sent to the PMDA and further examination is mainly conducted by this agency.

Description

Total Fee (Yen)

Drug containing the new ingredient, drug for a new route of administration, drug with a new combination, biotechnology based existing drug (excluding an orphan drug)

Drug containing the new ingredient, a drug for a new route of administration, drug with a new combination, biotechnology-based existing drug (orphan drug)

Drug with a new indication, drug with a new dosage form, drug for new dosage, and drug with similar formulation (excluding an orphan drug)

Drug with a new indication, drug with a new dosage form, drug for new dosage, and drug with similar formulation (orphan drug)