| OTO No. | 616 | Classification | MHW-255 | |
|---|---|---|---|---|
| Date of Acceptance | October 30, 2000 | Ministry/Agency Receiving Complaint | Cabinet Office (Economic Planning Agency) | |
| Responsible Ministries | Ministry of Health, Labour and Welfare (Ministry of Health and Welfare) | Related Laws | Pharmaceutical Affairs Law | |
| Complainant | Council of the European Business Community | Exporting Countries | Germany and France | |
| Subject | Relaxation of regulations on in-vitro diagnostics | |||
| Description of Complaint |
In-vitro diagnostics for diagnoses of illness and regular observation of patients are different from medicines injected into the human body and have no direct effect on the body. But the current Pharmaceutical Affairs Law classifies in-vitro diagnostics as medicines and requires import and sale of in-vitro diagnostics to be approved by the Minister of Health, Labour and Welfare. Although there are some exceptions for in-vitro diagnostics, it is necessary to prepare documents considering it as medicine and undergo complex examination procedures. While a standard examination period is set at six months, in fact, only 12% of total applications (as surveyed in May 1999) are approved within six months. Examinations of the remaining 88% take seven months to more than one year. Some take nearly two years.
In order to improve the situation, the industry has requested the Ministry of Health, Labour and Welfare to include in-vitro diagnostics into a category other than medicines. The industry has cooperated with the ministry in reviewing "Pharmaceutical Affairs Bureau Notice No. 622 (June 29, 1985)" as a basic notice on in-vitro diagnostics and in the operations of the "FY 1999 Survey Team on Standardization of In-vitro Diagnostics" (Kawai Team). Based on the above, the complainant makes the following requests regarding in-vitro diagnostics: (1) A system should be drafted to consider in-vitro diagnostics belong to a unique subcategory, though they are medicines under the Pharmaceutical Affairs Law. What specific actions will be taken ? How and when will the specific actions be taken ? (2) According to risk classification, in-vitro diagnostics of low risk should be exempted from the requirement of approval, while notification thereof is required, and the approval of only high-risk in-vitro diagnostics should be required. What specific actions will be taken in the future ? (3) Examinations of in-vitro diagnostics should be finished within six months. |
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| Details of Measures |
1. The ministry replied as follows: (1) "Treatment of In-vitro Diagnostics" (Pharmaceutical Affairs Bureau Notice No. 622, June 29, 1985) has already simplified approval application procedures for in-vitro diagnostics separately from conventional medicines. Based on a report by the "FY 1999 Survey Team on Standardization of In-vitro Diagnostics," the ministry is now reviewing application documents and other matters in cooperation with the EBC, ACCJ and the Japan Association of Clinical Reagents Industries, planning to expand the scope of document simplification by the end of March 2001. (2) The Survey Team on Standardization of In-vitro Diagnostics is now considering conditions for exempting in-vitro diagnostics from the requirement of approval. At present, however, the ministry considers it difficult to immediately eliminate the requirement of approval because 1) it is difficult to establish performance standards, 2) the concept of quality control has yet to diffuse, and 3) supply of standard products is not sufficiently available. The team has been continuing to investigate the reality of domestic quality and performance control systems and study comprehensive quality and performance control systems, which are introduced in foreign countries. (3) Examinations of in-vitro diagnostics are mostly finished within the standard processing period, six months. We are now instructing examiners to make check lists for preparation of appropriate application materials. In January 2001, we improved administrative procedures at the Organization for Pharmaceutical Safety and Research and Pharmaceuticals and Medical Devices Evaluation Center. 2. The ministry forwarded its additional reply at the 17th OTO Grievance Resolution Committee held on March 26, 2001 as follows: (1) The Organization for Pharmaceutical Safety and Research takes four to five months for administrative processing, while the Pharmaceuticals and Medical Devices Evaluation Center takes a few months. Therefore, the processing takes more than 6 months. (2) In effect from January 2001, the Organization for Pharmaceutical Safety and Research or Pharmaceuticals and Medical Devices Evaluation Center categorized items to be intensively examined respectively, in order to make improvements for efficient investigations and examinations. These improvement measures have already been disclosed to the respective authorities concerned through office communication on February 26, 2001. (3) In relation to application classification, except for those with novelty, in-vitro diagnostics are classified into those of high risk and of low risk according to health and hygienic risk. The application documents shall be simplified for the latter. The review of classification of the application documents is now under consideration. The ministry would like to send notice by the end of March. (4) Under the Pharmaceutical Affairs Law, the requirement of approval should be eliminated by setting performance standards. However, it takes time to set performance standards for all products. Other methods for eliminating the requirement of approval accompany the revision of law. 3. The ministry forwarded its reply at the 18th OTO Grievance Resolution Committee held on May 14, 2001 as follows: (1) Except for products with novelty, all in-vitro diagnostics are to be classified according to their health and hygienic risk. In effect from end of March 2001, the scope of classification in which documents have already been simplified has just been expanded. (2) On the assumption that the public monitoring system for after-sales performance and quality are strengthened, the following are conducted for in vitro diagnostics other than new ones and those with high health and hygienic risk: 1) For in vitro diagnostics of which standard products are provided under the established system in Japan, the requirement of approval is eliminated by setting performance standards (standards for eliminating requirement of approval): 2) For those of which standard products are not provided under the established system in Japan, performance standards cannot be set, therefore, eliminating the requirement of approval by companies themselves obliging quality assurance standards (GMP and so on) for quality control during the production process is being considered. Moreover, the ministry would like to examine the establishment of a system for providing new standard products. (3) Regarding the time of implementation, after adjusting the opinions of those concerned, the ministry will make efforts to implement the above 3 (2) 1) in the next one to two years. 4. The ministry made an additional reply at the 19th Grievance Resolution Committee on June 7, 2002 as follows: (1) The approval system will be reviewed based on risk classification of in-vitro diagnostics in the revised Pharmaceutical Affairs Law of which the bill is under deliberation in the current Diet session (154th). For in-vitro diagnostics that measure items of which diagnostic information is considered relatively low risk and of which self-check is easy since there is a standard substance for calibration, the requirement of approval is to be eliminated, and others are to be approved by a third party. Incidentally, only in-vitro diagnostics to measure new items or an item of which diagnostic information is at relatively high risk fall under the approval system. (2) The ministry is now considering a list (draft) of measuring items of which diagnostic information is considered at relatively low risk and standards (draft) for eliminating the requirement of approval of low-risk items with relevant organizations including the Japan Association of Clinical Reagents Industries. |
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| Classification of Processing | A | Directions | II-a | |
| Remarks |
A written reply was made on November 14, 2000
An additional written reply was made on February 14, 2001. Deliberated at the 17th Grievance Resolution Committee on March 26, 2001. Deliberated at the 18th Grievance Resolution Committee on May 14, 2001. Deliberated at the 19th Grievance Resolution Committee on June 7, 2002. |
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