Regulatory Affairs Consulting for Life Sciences in Japan

Expert Regulatory Affairs Consulting for Life Sciences Industries in Japan, Supporting Market Entry and Compliance

Services We Offer

Regulatory Affairs Services in Japan

At Artixio, we assist life sciences businesses in meeting Japan’s regulatory requirements. From product development to post-market support, our team works closely with you to ensure your products comply with local regulations.

We aim to make the approval process clear and efficient, helping your products reach the market confidently. With our expertise, you’ll receive guidance throughout the process, giving you the support you need to succeed in Japan.

Industry	Regulatory Body
Pharmaceuticals & Medical Devices	Pharmaceuticals and Medical Devices Agency (PMDA) Ministry of Health, Labour, and Welfare (MHLW)
Cosmetics	Ministry of Health, Labour, and Welfare (MHLW)
Nutrition Products	Consumer Affairs Agency (CAA)
Veterinary Products	Animal Health and Food Safety Department (MHLW)

Regulatory Affairs Lifecycle in Japan

Why Artixio for Japan’s regulatory affairs

We understand Japan’s unique regulatory environment and help you stay compliant.
Our team works closely with the PMDA and MHLW to handle all the regulatory processes.
With years of experience in Japan, we know the ins and outs of local requirements.
We’ve successfully guided numerous products through Japan’s approval process.
From initial submission to market launch, we’re here to support you every step of the way.

FAQs

What are the main regulatory bodies in Japan?

The Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour, and Welfare (MHLW) are the key authorities responsible for product approvals in Japan. For other products, such as food and cosmetics, the Consumer Affairs Agency (CAA) plays an important role.

What are the main requirements for submitting a product for approval in Japan?

You will need to submit a variety of documentation, including clinical data, safety profiles, manufacturing details, and product labeling, depending on the product type. It’s important to ensure that all documents meet Japanese standards.

What happens after my product is approved in Japan?

Once approved, your product will be registered, and you can begin market distribution. However, ongoing post-market surveillance and reporting are required to monitor product safety and effectiveness.

Are there any specific post-market requirements in Japan?

Yes, post-market surveillance is mandatory in Japan, and products must undergo periodic inspections and adverse event reporting. Continuous monitoring is essential to maintain compliance.