REFORM THE QUASI-DRUG APPROVAL SYSTEM

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2 REFORM THE QUASI-DRUG APPROVAL SYSTEM

3 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.

4 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 However, the information obtained from businesses was sparse and the book covers only a very limited number of raw materials.

5 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.

6 HARMONISE QUASI-DRUG & COSMETIC INGREDIENTS

7 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.

8 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.

9 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 quasidrug), and allow the use of fluoride in mouthwash and liquid toothpaste (quasidrugs) at an early date.

10 PROMOTION OF SELF-MEDICATION ADVISORY ROLE OF PHARMACISTS & GENERAL PRACTITIONERS

11 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.

12 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.

13 EXPANSION OF EFFICACY CLAIMS FOR COSMETICS & QUASI-DRUGS

14 Expansion of Efficacy Claims for Cosmetics & Quasi-Drugs YEARLY STATUS REPORT: No Progress Fifty-five efficacy claims were defined for cosmetics in the Notification on Revision of the Scope of Efficacy Claims for Cosmetics issued in 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.

15 Expansion of Efficacy Claims for Cosmetics & Quasi-Drugs RECOMMENDATIONS 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.

16 ELIMINATION OF NON-TARIFF BARRIERS FOR COSMETIC AND QUASI-DRUG IMPORTS

17 Elimination of Non-Tariff Barriers for Cosmetic & Quasi-Drug Imports YEARLY STATUS REPORT: No Progress The MHLW announced the abolishment of import notifications effective from 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.

18 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.

19 Elimination of Non-Tariff Barriers for Cosmetic & Quasi-Drug Imports RECOMMENDATIONS 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.

20 ELECTRONIC NOTIFICATION FOR COSMETICS & QUASI-DRUGS

21 Electronic Notification for Cosmetics & Quasi-drugs YEARLY STATUS REPORT: No Progress 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. RECOMMENDATION 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.

22 ESTABLISHMENT OF ALTERNATIVES TO ANIMAL TESTING

23 Establishment of Alternatives to Animal Testing YEARLY STATUS REPORT: No Progress 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.

24 Establishment of Alternatives to Animal Testing YEARLY STATUS REPORT: No Progress 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.

25 Establishment of Alternatives to Animal Testing RECOMMENDATIONS 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.