This e-book, “Entering Japan: A Practical Guide to Pharmaceutical Compliance and Market Access”, provides a comprehensive and practical overview for pharmaceutical companies aiming to enter the Japanese market. It explains the regulatory, logistical, and compliance challenges involved and presents step-by-step guidance on navigating Japan’s complex pharmaceutical environment.
Key topics:
- General Information about Japan: Discover what makes Japan a strategic choice. From its aging population to a world-class healthcare system driving pharmaceutical demand.
- Requirements for the Japanese Pharmaceutical Market: Navigating into the Japan’s Pharmaceutical Regulations: MHLW, PMDA, MAH.
- How To Enter The Japanese Market: Understand what you need to do to meet the highest Japanese quality standards.
- Case Studies: Real-world examples demonstrate different scenarios, such as how a European biopharmaceutical company successfully launched in Japan and how Marketing Authorization Holder (MAH) transfers are practically managed between international companies with Japanese subsidiaries.
Overall, the guide serves as a practical reference for foreign pharmaceutical companies, offering actionable strategies and best practices to ensure successful compliance and market access in Japan.
Download the e-book now to learn how we can help you and facilitate the entrance to the Japanese market 👇
