JPAL stands for Japanese Pharmaceutical Affair’s Law. The JPAL establishes regulations covering the manufacturing and distribution of medical devices and pharmaceutical products in Japan.

Compliance with the local laws can be one of the most challenging aspects when doing business in a foreign country. The JPAL intends to harmonize requirements and reduce conflicting demands by incorporating the guidance documents of the Global Harmonization Task Force (GHTF).

Benefits of the JPAL at a Glance:

• Compliance with various safety measures and post-marketing safety measures such as Good Clinical Practices (GCP), Good Quality Practices (GQP), and Good Vigilance Practices (GVP)
• Compliance with the ISO 13485:2003
• Access to global markets
• Meeting the requirements of set standards and regulations
• Procuring leads against the competition for lead audits
• Minimized risk of company liability with formulated safety standards
• Compliance with the local government and legal requirements

What are the Components of the JPAL Regulations?

The two (02) components of the JPAL regulations that are quintessential to doing business in Japan are “Kyoka” and “Shonin”:

1. Kyoka

The Marketing Authorization Holders (MAH), manufacturers, repairers, and distributors are required to submit a business license. In case the manufacturing facilities are located outside of Japan, the foreign manufacturing facilities are required to produce a Foreign Manufacturer Accreditation (FMA) instead of a Manufacturer License.

1. Shonin

To market medical devices in Japan, the MAH is required to register the device through the following procedures:

1. Pre-market submission (Todokede) –

Class I medical devices

1. Pre-market certification (Ninsho) –

 Class II medical devices

1. Pre-market approval (Shonin) –

 Class II, III, and IV medical devices 

Understanding the JPAL is fundamental to having an aligned presence in the Japanese market and providing manufacturing services to its pharmaceutical industry in collaboration with the local laws and regulations.

Having a blueprint of the local laws before entering the market influences the market-entry strategy heavily.

With Freyr’s expertise, you can have a one-stop service to overcome all these challenges in the Japanese market. Consult Freyr’s experts and get a clear understanding of the pharmaceutical laws in Japan for a better transition in the marketplace.