Request a DemoJapanese cosmetics are regulated under the Pharmaceuticals and Medical Devices Act (hereinafter referred to as "the Act"), which is issued by the competent authority, the Ministry of Health, Labour and Welfare (MHLW), and supported by a series of subsidiary rules, standards and guidance documents.
Under the Act, Japan legally classifies cosmetics (in the broad sense of beauty products) into two categories: cosmetics and quasi drugs. The regulations governing each category differ greatly.
Part 1 Definition
Quasi-drugs are defined as "substances which have mild effects on the human body, and have a specific function other than drugs or medical devices." There are mainly the following three classes:
No | Class | Product Example |
Ⅰ |
| Oral freshener, deodorant, antiperspirant, baby powder, depilatory, hair growth products, etc. |
Ⅱ | Products used to exterminate mice, flies, mosquitoes, fleas, or other animals or insects similar to these for the benefit of the health of humans and animals; | Helminthic, etc. |
Ⅲ | Products designated by MHLW containing approved active ingredients that have pharmacological action | Medicated cosmetics (including soap, shampoo, hand cream, etc.), hair dyes, hair perms, medicated oral-care products, etc. |
Table 1 Classification of Quasi-drugs
In the beauty field, quasi-drugs mainly refer to products added with active ingredients approved by MHLW in a prescribed dose, whose efficacy is between pharmaceuticals and cosmetics and is safe as cosmetics, with no side effects.
The most significant difference between quasi-drugs and cosmetics is whether they contain "active ingredients" that claim to have specific efficacies. Only products containing active ingredients approved by MHLW can be marketed as quasi-drug products in Japan. Besides, quasi-drugs can be sold not only in pharmacies, but also in convenience stores, supermarkets and other places where there is no pharmacist. For enterprises, the sales channels of quasi-drugs are more diversified than those of cosmetics.
Part 2 Competent Authorities
The Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) are the main agencies regulating quasi-drugs in Japan. PMDA is an independent administrative institution. It works together in conjunction with MHLW to develop comprehensive regulations, assess the safety and efficacy of quasi-drugs and cosmetics, and monitor their post-market safety. Their specific responsibilities are as follows:
MHLW
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PMDA
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In addition, county-level local governments also play an important role. They will supervise the products after they are on the market, and be responsible for the approval of marketing applications and manufacturing applications. Besides, they will also be responsible for the recall of substandard products.
Part 3 Ingredients Requirements
Japan implements a strict approval system for quasi-drugs. The focus of the approval lies on the efficacy, safety and quality specifications of ingredients.
3.1 Japanese Standards of Quasi-drug Ingredients 2021 (JSQI 2021)
Japanese Standards of Quasi-drug Ingredients 2021 (JSQI 2021) is the overarching technical standards for quasi-drugs, which specifies the most basic specification requirements and testing methods for quasi-drugs ingredients. The regulatory requirements for most of the ingredients in the lists of permitted active ingredients and the lists of permitted additives are related to the provisions in JSQI 2021.
In JSQI 2021, the ingredient specification involves these 16 items. But it shall be noted that not all ingredients give all these 16 items.
1) Japanese name (official name)
2) English name (chemical name);
3) Japanese name (another name);
4) Another name (English name);
5) Structural formula or rational formula;
6) Molecular formula and molecular weight;
7) Origin, the regulations of ingredients’ content and label;
8) characteristics;
9) Confirmation test;
10) Characteristic value;
11) Purity test;
12) Loss on drying, ignition loss, and moisture;
13) Ignition residue or evaporation residue;
14) Special test;
15) Quantitative method;
16) Others.
3.2 Permitted Active Ingredients
Since JSQI 2021 only stipulates the specifications of quasi-drug ingredients, MHLW has also formulated specific lists of the active ingredients allowed to be used in different types of quasi-drugs.
Notably, only the active ingredients in the list can be used. Stakeholders shall refer to the permitted active ingredients lists for specific use limits. If the listed ingredient’s use amount exceeds the given limit or its specification differs from the requirements in the permitted active ingredient lists, it needs to be reapplied as a new ingredient.
3.3 Permitted Additives
The additives refer to ingredients other than the active ingredients in quasi-drugs, such as excipients, stabilizers, emulsifiers, buffer agents, adhesives, colorants, fragrances, corrective agents, etc. MHLW has formulated three positive lists to manage additives.
3.4 Quasi-drugs with New Active Ingredients or Additives
Currently, the MHLW divides applications for quasi-drugs into five types, corresponding to different documentation requirements (as shown in Table 2 and Table 3). The first three types pertain to new ingredients. The "qualified quasi-drug" in the fourth type refers to a quasi-drug that is different from an approved quasi-drug but can be judged to be identical to the approved quasi-drug without conducting new tests relating to efficacy andsafety. And the "same quasi-drug" in the fifth type refers to a quasi-drug with the same formula but manufactured and sold by different enterprises with different names and packing.
Among them, the applications for quasi-drugs containing new ingredients are subject to more stringent requirements, requiring submission of documents on the new ingredient's efficacy, safety, ingredient formulation, use purpose, etc.
Table 2 Classification of New Ingredients Application for Quasi-drugs
No. | Items | Specific documents |
I | Origin and Discovery Process, Application Situation at Abroad | 1. Origin and Discovery Process 2. Application Situation at Abroad 3. Properties Comparison, or Comparison with Other Quasi Drugs |
II | Physical and Chemical Properties, Testing Specification and | 1. Chemical Constitutional Formula 2. Physical Constitutional Formula 3. Testing Specification and Testing Methods |
III | Stability Testing | 1. Long-term Storage Testing 2. Stress Testing 3. Accelerated Testing |
IV | Safety Testing Reports | 1. Single-dose Toxicity Study 2. Repeated-dose Toxicity Study 3. Genetic Toxicity Study 4. Carcinogenicity Study 5. Reproductive Toxicity Test 6. Local Irritation Test 7. Skin Sensitivity Test 8. Photo Safety Test 9. Absorption, Distribution, Metabolism and Excretion Tests 10. Human Patch Test 11. Long-term Dose (Safety) Test |
V | Efficacy and Function Reports | 1. Supporting Documentation of Efficacy and Function 2. Human Trial Reports |
Table 3 Documents Required for New Ingredients Application for Quasi-drugs
The registration duration for quasi-drugs with new additives is around one to two years while for quasi-drugs with new active ingredients is at least 5 years. For type 5, because the product formula has been approved by MHLW previously, if it goes well, the application time is generally half a year.
In addition, please note that there is also a hidden list of permitted ingredients for quasi-drugs in Japan, which is also known as the "List of Patented Quasi-drug Ingredients of Enterprises". The permitted ingredients on the list are separately applied by enterprises and approved by MHLW. Due to the protection of property rights, this list will not be open to the public and is controlled by MHLW. It is worth mentioning that the ingredients on the list are only allowed to be used by their applicants and are new ingredients for other enterprises.
Part 4 Import Procedures and Requirements
The conditions for successful import or sale of quasi-drugs are:
The seller or Japanese importer needs to obtain the "Marketing License";
The manufacturer needs to obtain the "Manufacturing License". For quasi-drugs manufactured overseas, the foreign manufacturer needs to obtain the "Accreditation of Foreign Quasi-drug Manufacturer";
The product itself shall complete application for "Marketing Approval" and obtain the approval from MHLW;
Additionally, "high risk" products also need to pass the GMP inspections conducted by PMDA.
4.1 Marketing License
The "Marketing License" is only for the sale of quasi-drugs. It cannot be used for manufacturing quasi-drugs. Manufacturers in Japan can submit the application to either MHLW or prefecture governments while importer can only submit to MHLW. The application form for importers requires company names and addresses of both importer and domestic marketing license holder.
To obtain the "Marketing License", enterprises need to arrange three different responsible persons: manufacture and sales responsible person, quality assurance responsible person, and safety management responsible person
Table 4 Qualification Requirements for Three Responsible Persons
In principle, Manufacture and Sales Responsible Person, Quality Assurance Responsible Person, and Safety Management Responsible Person need to work in the same place and not interfere with each other. However, one person is allowed to concurrently serve as "Manufacture and Sales Responsible Person, and Quality Assurance Responsible Person", or "Manufacture and Sales Responsible Person, and Safety Management Responsible Person", but it cannot assume the responsibilities of all three roles at the same time.
In addition to these staffing requirements, manufacturers and distributors of quasi-drugs must also comply with Good Quality Practice (GQP) and Good Vigilance Practice (GVP) to correctly conduct quality management operations and post-marketing safety management. The following are the procedures manuals required for GQP and GVP:
Table 5 GQP and GVP
4.2 Manufacturing License
The "Marketing License" is a necessary license for the manufacture of quasi-drugs. Manufacturer needs to obtain it before production.
Table 6 Classification and Necessary Conditions for Marketing License
If the quasi-drug is produced by a foreign manufacturer, the foreign manufacturer needs to obtain the "Accreditation of Foreign Quasi-drug Manufacturer" from MHLW. In fact, the "Accreditation of Foreign Quasi-drug Manufacturer" are essentially the same as the application of "Manufacturing License". It is also reviewed in accordance with the requirements of the "Manufacturing License". Notably, a Japanese marketing license holder who sells quasi drugs manufactured by a foreign manufacturer can also make an accreditation application on the foreign manufacturer's behalf.
The following is the application process of overseas manufacturers:
4.3 Marketing Approval
In addition to the licenses of the relevant enterprises, the product itself shall complete application for marketing approval and obtain the approval from MHLW before entering the market. Whether the product under application can be approved as a quasi-drug depends on whether the use of the product is within the scope of the Pharmaceuticals and Medical Devices Act, according to its ingredient, content, function, efficacy, usage, dosage form, etc.
The necessary review items for quasi-drugs are as follows:
Trade name
Ingredients and content or traits: the name, content, specification and purpose of ingredients in the product formula
Manufacturing process
Usage and dosage
Function or efficacy
Storage method and validity period
Specifications and test methods
In general, it takes at least 6-8 months for products to be approved by MHLW.
4.4 GMP Inspections Application
The purpose of GMP inspection is to ascertain whether their manufacturing facilities, manufacturing and quality controls comply with standards such as the Good Manufacturing Practice (GMP), and whether the manufacturing sites have a system for manufacturing products with adequate quality.
GMP inspections are mainly divided into new inspection and regular inspections.
New GMP compliance inspection | Regular inspection | |
Introduction | Compliance inspection for applications of manufacturing licenses and marking licenses as well as applications for change approval | After the approval of the manufacturing and sales licenses, a conformity survey will be carried out every 5 years. |
Required documents |
(Note: for inspections of a foreign manufacturing sites, a GMP compliance certificate issued by a country; or a WHO certificate or a GMP compliance certificate issued by the authority of a country are also required.)
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Table 7 Classification of GMP inspections
In practice, PMDA will conduct on-site and document-based inspections on domestic and foreign manufacturing sites for products classified as “high-risk” (as shown in the Table 8). It is worth noting that although GMP inspection is a mandatory requirement for manufacturers who intend to obtain the marketing approval of quasi-drugs, the manufacturing license and the accreditation of foreign quasi-drug manufacturer, MHLW allows some quasi-drugs to be exempted from GMP requirements and not to apply for a GMP compliance investigation.
Quasi-drugs requiring GMP inspections | Quasi-drugs exempt from GMP inspections |
1. products intended to improve stomach discomfort 2. Anti-snoring drug 3. Health medicine with calcium as the main active ingredient 4. Mouthwash 5. Stomachic 6. Oropharyngeal medicine 7. Contact lens wearing medicine 8. Antiseptic disinfectant 9. Laxative 10. Chilblains/fissure medicine 11. Digestive medicine 12. Products intended for nutritional tonicity, improvement of weak constitution and nutritional supplementation 13. Herbal remedy 14. Intestinal regulators 15. Products intended to supplement vitamins or calcium in middle-aged and elderly people, or during physical fatigue 16. Products intended to improve throat discomfort 17. Nasal congestion reliever(limited to external agents) 18. Vitamin-containing health Drugs 19. products listed in item 5, item 11 or item 14 that fall under any two or more | 1. Cottons intended to be used for hygiene (including paper cottons) 2. Products intended to disinfect or protect scratches,cuts,puncture wounds, shoe sores,wound surfaces, etc. 3. Hair dying 4. Disinfectant for soft contact lens 5. Hair perms 6. Products intended to improve cracks, heat rashes, sores, calluses, rough limbs, dryness, etc. 7. Products intended to prevent acne, rough skin, rash, frostbite, etc., and also be used for sterilization and disinfection of skin or mouth 8. Bath additives |
Table 8 Quasi-drugs Requiring GMP Inspections and Quasi-drugs Exempt from GMP Inspections
Part 5 Labeling & Efficacy Claims
The labeling content for cosmetics and quasi-drugs is essentially the same, but quasi-drugs have several special requirements.
Labeling Items | Cosmetic | Quasi-drug |
The name and address of the manufacturer or importer | √ | √ |
The words "Quasi-drug(医薬部外品)" | X | √ |
Product name | √ | √ |
Manufacturing number or manufacturing mark | √ | √ |
Net content such as weight, capacity, or number | √ | √ |
Labeling of ingredients | Full ingredients | Designated ingredient (including active ingredient) |
Validity period | √ | √ |
The name and country of residence of the person who has obtained the foreign manufacturing license, and the name and address of the domestic manager | √ | √ |
Warning information | √ | √ |
Table 9 Comparison of Labeling Items for Cosmetics and Quasi-drugs
MHLW doesn't offer a reference list of permitted or prohibited efficacy claims for quasi drugs. The efficacy claims of quasi-drugs are based on active ingredients contained and can only be marked after getting an approval.
E.g.
Whitening efficacy: The product must contain a whitening active ingredient
Anti-acne efficacy: The product must contain an anti-acne active ingredient
Part 6 Post-market Supervision
Post-market supervision of quasi-drugs mainly includes adverse reaction reports or product recalls. The table below lists the situations in which an adverse reaction report or product recall is required.
Side Effect Report:
| Product Recall:
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