Quasi-drug manufacturing license
Updated: July 2025, 10
A quasi-drug manufacturing license is a license required to manufacture quasi-drugs.
Permits must be obtained for each manufacturing site and manufacturing category.
In order to obtain a manufacturing license, you must meet the requirements, apply to the prefectural governor, and undergo an on-site inspection.
At Support Administrative Scrivener Corporation, we provide full support from the stage of preparing requirements to acting on your behalf to apply for permission and witnessing on-site inspections.
1. What you can do with manufacturing certification
"Manufacturing" here includes not only acts such as bulk mixing and filling that handle the contents, but also acts related to the exterior, such as packaging, labeling, and storage.
Manufacturing licenses for quasi-drugs are divided into the following three categories, and the scope of possible manufacturing activities is determined for each category.
| Provisions of Article 2, Paragraph XNUMX of the Pharmaceutical and Medical Device Act Enforcement Regulations | Common name |
| Sterile quasi-drugsCan perform all or part of the manufacturing process. | Sterile classification |
| Sterile quasi-drugsother thanCan perform all or part of the manufacturing process. | General classification |
| Packaging, labeling, and storage in the manufacturing process of quasi-drugsonlycan be done. | Packaging classification |
*If a manufacturing company has a separate warehouse and uses it to carry out operations incidental to manufacturing activities (such as storing products awaiting shipping decision and storing and shipping products after the shipping decision has been made), a manufacturing license is required.
A manufacturer's separate warehouse refers to a warehouse that is used solely for storing products or materials made by the same manufacturer.
(December 25, 12 Administrative Communication “About GMP Case Studies (19 Edition)” Part 2013 GMP2-0)
(Flow chart from production to consumption of quasi-drugs)
2.Three points for obtaining manufacturing certification
When obtaining a manufacturing license for quasi-drugs, there are three points to consider: ``people,'' ``products,'' and ``obtaining other licenses at the same time.''
Let's check it out.
1) Person requirements
Manufacturers must physically manage the production of quasi-drugs as a requirement for “people”"Responsible Engineer"are required to be placed at each manufacturing site.
The requirements for a responsible engineer are stipulated as follows (Article 91, Paragraph 1 of the Enforcement Regulations of the Pharmaceutical and Medical Device Act).
When applying, the materials to be submitted will vary depending on the requirements you meet.
Some items may take some time to obtain, so you need to prepare well in advance.
Requirements for “Responsible Engineer” (for quasi-drugs subject to GMP ministerial ordinances, only ①)
①Pharmacist
② Those who have completed a specialized course related to pharmacy or chemistry at a university, etc.
3) Those who have completed a specialized course in pharmacology or chemistry at a former junior high school or high school or an equivalent school and have been engaged in the manufacturing of pharmaceuticals or quasi-drugs for three years or more.
④A person who is recognized by the Minister of Health, Labor and Welfare as having knowledge and experience equivalent to or greater than those listed in the previous three items.
*Only in the case of packaging, etc. category, experience in warehousing, packaging, and labeling at a branch warehouse of an import sales business under the Pharmaceutical and Medical Device Act before the revision may be added (December 16). Month 12th administrative communication Q&A 28)
*Specifically, ④ is defined as "a person who has been engaged in the manufacturing of pharmaceuticals, quasi-drugs, or cosmetics (including work related to manufacturing control or quality control) for 5 years or more." (Administrative Q&A dated March 28, 3)
*Even if a manufacturing company has multiple separate warehouses, the same person can be the responsible engineer for all separate warehouses as long as it does not interfere with the duties of the responsible engineer.
(December 25, 12 Administrative Communication “About GMP Case Studies (19 Edition)” Part 2013 GMP2-0)
2) Product requirements
Next, as a requirement for "products", the structure and equipment of the manufacturing facility are"Regulations for Structures and Facilities of Pharmacies, etc."are required to meet the criteria.
Of course, this takes time and money. It's hard when you prepare and then find out later that it doesn't fit. We recommend that you consider this carefully at the drawing stage.
There are differences in the structures and facilities required for sterile classification, general classification, packaging, etc. classification, and you often find yourself asking, ``How should I interpret this?''
We at Support Administrative Scrivener Corporation also receive many consultations.
3) Considering permission to obtain together
The last thing you should consider is whether there are any other permits you should obtain at the same time.
In particular"Cosmetics manufacturing industry",“Whether or not we should also obtain a license for manufacturing and sales business.”.
If you can obtain a manufacturing license for quasi-drugs, it is safe to assume that you can also obtain a manufacturing license for cosmetics unless there are special circumstances.
Additionally, if you obtain a manufacturing and sales license in addition to manufacturing, it will be much easier to develop your own products.
Even if we accept OEM etc., the range of targets will expand considerably.
The license for manufacturing and sales business is a system-related permit, and the burdensome requirements for "products" are lighter than for the manufacturing industry. On the other hand, there is a hurdle in appointing a responsible person, but in some cases it is possible for the person to serve concurrently as the responsible engineer.
We receive many enquiries from both people who are seeking individual permits and those who are seeking all permits at once.
3. Cost and period involved
In the case of Tokyo... (*Varies depending on the municipality)
Administrative processing period: 35 business days (approximately 7 weeks)
Where to submit your application: Tokyo Metropolitan Health and Safety Research Center, Wide Area Surveillance Department
Pharmaceutical Affairs Supervision and Guidance Division Pharmaceutical Review
Permit validity period 5 years
Legal fee Quasi-drug manufacturing license (license category: sterile) ... 43,700 yen
Quasi-drug manufacturing license application (license category: general)... 39,000 yen
Quasi-drug manufacturing license application (license category: packaging, etc.)... 32,800 yen
*In addition, various fees will be required for the application, including actual costs and external testing and inspection institutions.
Fees will be charged when using the service.
Please contact the support administrative scrivener corporation.
At Support Administrative Scrivener Corporation, we have extensive experience in procedures related to quasi-drugs, and our specialized staff quickly and reliably handles various applications for our customers.
①Speed compatible
Our speedy response has been praised by many customers, and we support your company's entry into the business as quickly as possible, from building an organizational structure to preparing documents and obtaining permits to start your business.
② Easy contact system
We offer free consultations.
We have offices in three locations across the country - Tokyo, Nagoya, and Osaka - and provide nationwide service from these bases.
We accept consultations from overseas via the internet, and consultations outside of business hours are also possible in the evenings, on weekends, and on holidays if you make a reservation in advance.
We also have staff who can speak Chinese, English, and Korean, so we can help you even if it is difficult to consult in Japanese.
If you are having trouble applying for quasi-drug approval, please feel free to contact us!
③ We also provide solid support for building a compliance system.
We can create procedure manuals (GVP, GQP), etc. in a format that suits your company's actual situation while still meeting the standards.
We also have extensive experience in permit renewals and provide internal audit support.
For business operators, obtaining a permit is not a goal, but a starting point.
We provide solid support with an eye toward the future.
Our dedicated staff handles cases nationwide.
