Press Release: GRP Japan becomes Quasi-Drug MAH licensed by PMDA


GRP Japan broadened this product registration portfolio on November 1st 2022, when the PMDA approved them for MAH license of Quasi-Drugs in Japan. The license was issued after an on-site inspection was held of GRP quality and Safety protocols and personnel. 

GRP currently possesses MAH Licenses for Medical Device, IVD, Category I Drugs, Cosmetics and Quasi-Drugs.

What are quasi-drugs?

In the Pharmaceuticals and Medical Devices Act, “quasi-drugs” means the following substances that have a mild effect on the human body. 

The following products are examples included in the quasi-drug category: 

  • Items intended to improve stomach discomfort 
  • Cotton intended to be used for hygiene purposes (including paper cotton) 
  • Gargle 
  • Oropharyngeal drugs 
  • Medicated medicines for shavings and cracks
  • Laxative 
  • Items intended to be used for disinfection or protection of scratches, cuts, nicks, scratches, slippage, wound surfaces, etc. 
  • Hair dye 
  • Disinfectant for soft contact lenses 
  • Items intended to improve throat discomfort 
  • Permanent wave agent 
  • Nasal congestion remedy (external drug only) 

What is a MAH for Cosmetics in Japan?

Marketing Authorization Holder (MAH) is also known as the Manufacturing and Sales license. 

Responsibility of MAH include the following activities:

  • Submission and management of list of Cosmetics
  • Review client products and comply with the regulation
  • Quality Control
  • Release testing (Can be outsourced)
  • Manage Quality Control
  • Safety Management
  • Customer Management
  • Safety information handling
  • Report the safety information to PMDA
  • Management of recall

GRP MAH licenses

about global regulatory partners

Global Regulatory Partners, Inc (GRP) is a global provider of tailored clinical development, regulatory affairs, quality and pharmacovigilance services for pharma, biotech, medical devices and cosmetic industries worldwide. Global Regulatory Partners. Inc, has now over 500 employees, 6 affiliates in 6 countries (USA, Brazil, Mexico, Japan, China and South Korea) and more than 500 satisfied clients worldwide.