SAKIGAKE designation for drugs in Japan

What is SAKIGAKE Designation?

Overview:

PMDA created a new regulatory pathway known as “SAKIGAKE” that allows the accelerated approval of drugs designated as breakthrough therapies and addressing unmet medical needs in Japan.

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GRP Japan office is licensed by local health authority, the PMDA, act as your Market Authorization Holder (MAH) in Japan.
  • Product registration
  • Communication with the PMDA
  • Assistance with PMDA inspections
  • Adverse Effect Reporting
  • Importation of products
  • Support importation process
  • Organize and support PMDA consultation meetings
  • Product storage in an establishment with MAH licensing
  • Post-market vigilance
  • Manage Distributors

ABOUT GLOBAL REGULATORY PARTNERS INC.

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.

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