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
Cosmetic MAH
Pharma MAH
Quasi-Drug MAH
IVD-MAH
MD-MAH
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.