What is the Sakigake Drug Designation System in Japan?

The Sakigake Drug Designation System is a program launched by the Japanese government in 2014 to promote the development and early practical application of innovative medical products with better efficacy.

The program is administered by the Pharmaceuticals and Medical Devices Agency (PMDA), the Japanese Regulatory authority responsible for ensuring the safety, quality, and efficacy of pharmaceuticals and medical devices in Japan.

For a drug to be eligible for Sakigake designation, it must meet the following criteria:

• It must be a new drug that is intended to treat a serious or life-threatening disease.
• It must offer a new mechanism of action or a significant improvement over existing treatments.
• It must carry the potential to significantly improve patient outcomes.

If a drug is designated under the Sakigake system, it becomes eligible for several benefits, including:

• Priority consultations with the PMDA during the drug development process.
• Prior assessment of clinical trial data that can help identify and address any potential safety or efficacy issues early on.
• Priority review of marketing authorization applications.
• Support for clinical trials and post-marketing surveillance.

The Sakigake Drug Designation System is designed to help companies bring new drugs into the Japanese market at a greater speed and with more efficiency. It can, in turn, benefit patients by giving them earlier access to new treatments. If patients start receiving treatment sooner, it can improve their chances of survival and recovery to a great extent.

Do you want to learn more about how the Sakigake Drug Designation System can help you bring your new drug into the Japanese market? Contact Freyr’s Regulatory team today!