Medical equipment/cosmetics/pharmacies

Quasi-drug license/approval

Updated: July 2025, 10


Administrative scriveners are not only qualified to prepare documents.
We are experts in startups, including companies that are starting new businesses and companies that are entering different industries.
There are many consultants with specialized know-how in the quasi-drug industry, but we have the know-how and track record that only administrative scriveners can accumulate, as they represent companies on a daily basis and handle applications and negotiations with administrative agencies. .
By making full use of our know-how and track record, we support the smooth startup of our clients.
Please use Support Administrative Scrivener Corporation as your partner for new business and new entry.

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Chief Consultant Sachiko Masuno
  • I don't really understand the procedure for applying for a permit.
  • How do I apply for an FD?
  • I don't know how to create procedure manuals (GVP, GQP) that are appropriate for my company's case.
  • How can I import quasi-drugs from overseas?
  • I would like support for procedures to change when there are changes to officers or responsible persons.
  • The deadline for approval of quasi-drugs is fast approaching, what should I do?
  • We have reviewed the distribution flow for quasi-drugs, but is it okay to leave the current procedure manual as it is?
  • Apparently, a site inspection will be conducted again when applying for renewal. Is there anything I should do to prepare?
  • I haven't been able to create the documents that are required to be created and recorded in the procedure manual...is this okay?
  • I suddenly got a call from the Pharmaceutical Affairs Department...they said they were conducting a regular inspection, but what should I do?
  • Advice on the construction of structures and facilities required for new permit applications and internal systems
  • Preparation of FD application forms and various attachments
  • Prior consultation with the Pharmaceutical Affairs Division, Public Health Center, etc.
  • Preparation of necessary documents such as procedure manuals (GVP, GQP)
  • Obtaining various certificates on your behalf
  • Application to pharmaceutical affairs departments, public health centers, etc.

We handle all the tasks up until the start of business, focusing on the services listed above.
Furthermore, we provide thorough support for improving compliance systems, such as reviewing organizational structures and procedures (GQP/GVP) and supporting the checks of daily pharmaceutical operations!

General flow of the quasi-drug approval stage

Consultation and application Consultation is free. Please contact us by phone or through the inquiry form. After confirming the current situation, we will explain the application policy. Once you have confirmed the amount and service content presented in the estimate, you can apply. Preliminary consultation, on-site inspection if necessary We will advise you on the structure and equipment required for application and the construction of the internal system. Depending on the jurisdiction, we will conduct a preliminary consultation with the pharmaceutical affairs department or health center. Basically, we can act on your behalf, but we may ask you to accompany us. Application agency After preparing the application documents, we will submit the entire application to the pharmaceutical affairs department of the prefecture in charge (※In rural areas, it may be via the health center). At that time, a fee will be paid. The amount of the fee also varies depending on the prefecture to which the application is made. On-site inspection After the application, the pharmaceutical affairs department will contact you within 1 to 2 weeks to schedule the on-site inspection. The on-site inspection usually takes the form of about two officials visiting the company. We will check the application contents, confirm the knowledge and experience of the person in charge, confirm the establishment status and contents of the procedure manual, and confirm the location. Our staff will provide support, such as a pre-lecture and being present on the day. Issuance of license In Tokyo, after receiving the permission postcard, you will go to collect the license. Depending on the jurisdiction, you may be contacted by phone rather than by permission postcard (Kyoto Prefecture, etc.). Commencement of business Quasi-drug manufacturers and distributors who actually sell quasi-drugs must complete the product procedures in advance. Procedures are also required in advance when selling imported quasi-drugs.

General flow of the quasi-drug approval stage

General flow of quasi-drug approval stages

Fast response and fastest application

Our company specializes in speedy response.
By entrusting the application to an administrative scrivener who specializes in applying for new licenses for quasi-drugs, you can smoothly prepare everything from building an organizational structure to preparing documents, allowing you to enter the business as quickly as possible.

Free consultation 

If you make a reservation in advance, we can also accommodate consultations outside of business hours, such as at night or on weekends and holidays.
If you are having trouble applying for quasi-drug approval, please feel free to contact us!

Support for building a compliance system for business operations

Procedure manuals (GVP, GQP), etc. can be created in a format tailored to the actual situation of each applicant, so it is possible to appropriately establish a compliance system for business operations after obtaining a license.

Support for smooth business start-up after obtaining permission

Our staff will be responsible for collecting time and certificates from the pharmaceutical department, public health center, etc.
By reducing complicated work, customers can spend time creating a website and improving their sales structure after starting their business, which can lead to a smooth start of their business after obtaining a permit.

[Expert explains]
Latest Topics on Quasi-drugs


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