reform the quasi-drug approval system...reform the quasi-drug approval system yearly status report:...

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.



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.


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


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.



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.


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


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


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.



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.


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


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.


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.



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


reform the quasi-drug approval system...reform the quasi-drug approval system yearly status report:...

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