Japan has a robust regulatory framework for pharmaceuticals and medical devices, which includes specific requirements for In-Country Clinical Caretakers (ICCC). Foreign manufacturers that wish to penetrate the Japanese market must appoint an ICC, who resides in Japan, to sponsor the clinical trials on their behalf. Thus, they play a crucial part in ensuring that foreign companies can successfully conduct clinical trials and meet regulatory requirements of the PMDA to obtain market approval for their products.
What is an In-Country Clinical Caretaker?
The In-Country Clinical Caretaker (ICCC) is a vital figure for foreign sponsors conducting clinical trials in Japan. Under Japan’s Pharmaceuticals and Medical Devices Act, the ICC is designated by the foreign sponsor to represent them during the clinical trial process. The responsibilities of the In-Country Clinical Caretaker are outlined in the Japanese Good Clinical Practices (GCP) Regulation.
The key duties of an ICC include:
1. Clinical Trial Notification (CTN): Submitting the CTN, including the protocol and Investigator’s Brochure (IB), to the Pharmaceuticals and Medical Devices Agency (PMDA). This documentation must be in Japanese, making the ICC’s role critical for foreign sponsors.
2. Clinical Trial Protocol Consultation: Participating in discussions with the PMDA to seek approval for the study, including investigating indications for use, sample size, endpoint validity, and statistical analysis
3. Conducting Clinical Trials: Managing various aspects of the clinical trial, often in collaboration with a Contract Research Organization (CRO). This includes annual IB reviews, device accountability, and reporting Serious Adverse Events (SAE) to the PMDA.
The ICC ensures that clinical trials are conducted in alignment with Japan’s GCP Regulation, maintaining high standards and adherence to the country’s regulatory requirements.
Conclusion
Japan’s regulatory framework for pharmaceuticals and medical devices reflects its commitment to maintaining high standards and safety in the healthcare industry while ensuring foreign companies can navigate its market effectively. Careful consideration of the roles and responsibilities of ICCs is essential for successful market entry and compliance with Japanese regulations. DDReg has provided its customers with end-to-end regulatory services to support successful market access and post approval life cycle management for their products, with Japan PMDA. Read our previous blog on the Regulatory Framework for Cosmetics in South Korea.