REFORM THE QUASI-DRUG APPROVAL SYSTEM
Reform the Quasi-Drug Approval System
YEARLY STATUS REPORT: Slight Progress
In 2014, the Ministry of Health, Labour and Welfare (MHLW) released a ministerial
notification called Examination Guidance on Medicated Shampoos and Conditioners.
This improved the transparency of the quasi-drug review system.
The notification was originally intended to speed up the review process, but unfortunately, there is no commitment in this notification to shorten the review period.
Reform the Quasi-Drug Approval System
YEARLY STATUS REPORT: Slight Progress
In addition, the Pharmaceuticals and Medical Devices Agency (PMDA) collected
information from businesses on raw material specifications of already approved excipients and published a book entitled, “Standards of Excipients for Quasi-drugs” in 2014.
However, the information obtained from businesses was sparse and the book covers only a very limited number of raw materials.
Reform the Quasi-Drug Approval System
RECOMMENDATIONS
MHLW should create review guidance covering all quasi-drugs and eventually use it as an approval standard to shorten the review period for those items that are believed to be identical to already approved quasi-drugs.
MHLW should consider the introduction of a master file system for ingredients
used in quasi-drugs in order to improve the transparency of the quasi-drug review system while protecting proprietary information on the ingredients (intellectual property) of the respective companies.
MHLW should allow the use of excipients in cosmetics without restrictions or limits,
as long as there are no special notes regarding safety or usage restrictions for each ingredient.
HARMONISE QUASI-DRUG & COSMETIC INGREDIENTS
Harmonise Quasi-drug & Cosmetic Ingredients
YEARLY STATUS REPORT: Slight Progress
The EU and Japan maintain different rules governing which ingredients are allowed
in cosmetics, expressed respectively in terms of negative and positive lists. The fluoride concentration levels permitted in oral care products in Japan are not
aligned with the higher levels permitted in other developed countries. Japan permits a maximum of 1,000 parts per million (ppm) of fluoride in toothpaste
sold as a quasi-drug, while concentrations of fluoride of up to 1,500 ppm are allowed in Europe.
Harmonise Quasi-drug & Cosmetic Ingredients
YEARLY STATUS REPORT: Slight Progress
Mouthwash with fluoride concentrations of 226 ppm is sold at drugstores and
supermarkets throughout Europe and the United States. In 2015, Japan approved the use of fluoride in mouthwash for general consumption,
but only as a drug requiring guidance.
Harmonise Quasi-drug & Cosmetic Ingredients
RECOMMENDATIONS
MHLW should resolve the inconsistency between Japan and the EU in the
maintenance of positive and negative lists for all quasi-drug and cosmetic ingredients.
MHLW should revise the medicated dentifrice approval standard by raising the
upper limit of fluoride concentration allowed in medicated toothpaste (a quasi-drug), and allow the use of fluoride in mouthwash and liquid toothpaste (quasi-drugs) at an early date.
PROMOTION OF SELF-MEDICATION ADVISORY
ROLE OF PHARMACISTS & GENERAL PRACTITIONERS
Promotion of Self-medication Advisory Role of Pharmacists & General Practitioners
YEARLY STATUS REPORT: No Progress
Self-medication is the selection and use of medicines by individuals to treat
recognized illnesses or symptoms.
It includes products sold as quasi-drugs.
If more people were to visit general practitioner doctors and pharmacists for advice and use Over-The-Counter (OTC) and quasi-drugs to manage minor health problems, then specialist doctors at major hospitals would have more time to focus on other patients with more serious conditions.
This would improve health and help reduce total healthcare spending.
Promotion of Self-medication Advisory Role of Pharmacists & General Practitioners
RECOMMENDATION
Japan should promote self-medication where it is safe and appropriate to do so by
creating financial incentives for patients, pharmacists and medical institutions.
EXPANSION OF EFFICACY CLAIMS FOR COSMETICS &
QUASI-DRUGS
Fifty-five efficacy claims were defined for cosmetics in the “Notification on
Revision of the Scope of Efficacy Claims for Cosmetics” issued in 2000. In 2011,
the efficacy claim of “making fine wrinkles due to dryness less noticeable” was added to the list.
Yet the scope of efficacy claims approved in Japan is still narrower than in other countries, which hinders the entry of foreign-made cosmetics based on the latest research and technology to the market.
Expansion of Efficacy Claims for Cosmetics & Quasi-Drugs
YEARLY STATUS REPORT: No Progress
Japan should expand and harmonise the scope of positive efficacy claims for
cosmetics and quasi-drugs with that of the EU. To align with the EU regulations, the MHLW should abolish the efficacy claim list
and allow companies to communicate product efficacy within the definition of cosmetics based on verifiable data.
Expansion of Efficacy Claims for Cosmetics & Quasi-Drugs
RECOMMENDATIONS
ELIMINATION OF NON-TARIFF BARRIERS FOR COSMETIC AND
QUASI-DRUG IMPORTS
The MHLW announced the abolishment of import notifications effective from 2016. This will significantly simplify import procedures. However, during customs
clearance, paper-form submission of the Notification on Manufacture and Sale of Cosmetics and other documents may be required, and it is highly possible that the currently available electronic NACCS procedures will no longer be used.
Elimination of Non-Tariff Barriers for Cosmetic & Quasi-Drug Imports
YEARLY STATUS REPORT: No Progress
The MHLW also eased the rules of the Partial Change Approval for prescription
drugs and it is now possible to sell both the old and the new changed product during a 6-month-period (grace period).
This enables the applicant to confidently perform product stock control, procure
materials related to product marking, and change the quality control operation as required.
Elimination of Non-Tariff Barriers for Cosmetic & Quasi-Drug Imports
YEARLY STATUS REPORT: No Progress
In addition to abolishing import notification as planned, MHLW should also accept
electronic customs clearance procedures. MHLW should expand the revision of the rules on Partial Change Approvals to cover
quasi-drugs as well.
Elimination of Non-Tariff Barriers for Cosmetic & Quasi-Drug Imports
RECOMMENDATIONS
ELECTRONIC NOTIFICATION FOR COSMETICS &
QUASI-DRUGS
In many other countries, the Government and businesses have jointly established and operate an online electronic notification system.
In Japan, with the exception of import notifications, notifications and applications are submitted using floppy discs and paper documents.
Electronic Notification for Cosmetics & Quasi-drugs
YEARLY STATUS REPORT: No Progress
An online notification and application system should be established for issuing Notifications on Manufacture and Sale of Cosmetics and Application for Approval of Quasi-drugs. This system should also be accepted in customs clearance procedures.
RECOMMENDATION
ESTABLISHMENT OF ALTERNATIVES TO ANIMAL
TESTING
Cosmetic and quasi-drug manufacturers are still expected to submit safety data
based on animal testing in Japan and validated alternatives are limited.
The MHLW guidance on replacing the skin sensitisation test took effect in May 2013, corresponding to Organization for Economic Co-operation and Development (OECD) guidelines 442A and 442B.
Further, the MHLW guidance on replacing the eye irritation test with the bovine corneal opacity and permeability test (BCOP) came into effect in February 2014.
YEARLY STATUS REPORT: No Progress
Establishment of Alternatives to Animal Testing
In Europe, the human cell line activation test (h-CLAT), which is validated by the
European Centre for the Validation of Alternative Methods (ECVAM), is recommended in the OECD test guideline.
In Japan, this is still at the stage of third-party evaluation.
YEARLY STATUS REPORT: No Progress
Establishment of Alternatives to Animal Testing
Japan should accelerate the establishment of validated alternatives for animal
testing of ingredients and products based on safety endpoints that are harmonised with those used in the EU.
Japan should accelerate its international commitment to protect humans, animals
and the environment.
RECOMMENDATIONS
Establishment of Alternatives to Animal Testing