| OTO No. | 644 | Classification | MHLW-(8) | |
|---|---|---|---|---|
| Date of Acceptance | September 12, 2001 | Ministry/Agency Receiving Complaint | Cabinet Office | |
| Responsible Ministries | Ministry of Health, Labour and Welfare | Related Laws | Pharmaceutical Affairs Law | |
| Complainant | Domestic firms | Exporting Countries | USA | |
| Subject | Prompt processing of an application for import approval of a quasi-drug that contains an existing ingredient as a new effective ingredient | |||
| Description of Complaint |
The complainant made an application for import approval of a quasi-drug that contains an existing cosmetic ingredient as a new effective ingredient to the Minister of Health, Labour and Welfare, and obtained acceptance of the application on January 31, 2000. It has been around one year and seven months since the acceptance. The application has not been approved and has no prospect of approval, not only forcing the complainant to cancel its initial plan of introduction, but preventing it making a new plan of introduction. In the case of an application for an approval by the Minister, the standard examination period is supposed to be six months (excluding the time for the applicant to correct its application documents and the time the applicant spends answering the questions by the examination council.). A view has been recently announced that the ministry would like to have the target examination period of one year for new medical supplies. The circumstances surrounding the application were: 1) Since the quasi-drug contains a new effective ingredient, application was made under the application category 1 for new quasi-drugs. However, the ingredients and their quantities contained besides the effective ingredient are the same as those of similar quasi-drugs that have already been approved. 2) The new effective ingredient may be contained in cosmetics under the old category-by-category approval system and the quantity in the quasi-drug does not exceed the limit permitted. 3) Therefore, the safety and stability of the product has been proved and the main examination point of this application will be the evaluation of the effectiveness of the newly added efficacy. 4) The Ministry of Health, Labour and Welfare have given, until now, the applicant a total of three instructions to provide additional data and correct documents, which took the applicant a total of approximately six weeks. The applicant requests the ministry to more promptly process the application as well as indicate an approximate examination period for this application and applications concerning this kind of quasi-drug. |
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| Details of Measures |
The ministry replied as follows: The product is a quasi-drug that has as a selling point a new efficacy or effect based on a new effective ingredient contained in it. However, the attached documents and data has not sufficiently proven the significance of adding the new ingredient, nor clarified the validity of the new efficacy or effect, making the claim for the new efficacy inappropriate. The ministry has been asking applicants who claim a new efficacy or effect to set such a test method as well as clearly show its action. This is because when there are many academic theories about an efficacy or effect, even the latest studies often fail to make a conclusions about it, leading the ministry to take a cautious stance on making a judgment on the efficacy, and thus take time for its examination. However, the ministry will admit the fact that it has taken more time than the standard processing time. The ministry will make a judgment on the application after requesting further explanations about whether the product can claim a new efficacy. Incidentally, since examination periods for similar quasi-drugs vary according to the contents of their applications, the periods cannot be flatly determined. |
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| Classification of Processing | D | Directions | II-a | |
| Remarks | A written reply was made on September 25, 2001 | |||