Provisional Translation
| OTO No. | 586 | Classification | MHW-248 |
|---|---|---|---|
| Date of Acceptance | January 8, 1999 | Ministry/Agency Receiving Complaint | Economic Planning Agency |
| Responsible Ministries | Ministry of Health and Welfare | Related Laws | The Pharmaceutical Affairs Law |
| Complainant | Domestic firm | Exporting Countries | USA |
| Subject | Speeding up examination procedures for approval of contact lenses | ||
| Details of Measures | Description of Complaint: 1. In order to newly import and sell disinfectant for contact lenses, it is necessary to change the content of approval of the contact lenses for which the said disinfectant is scheduled to be used. In such a case, results of cell toxicity tests must be attached, in accordance with the ministry's guidelines. 2. The complainant filed the application for a change of approval, but was asked to provide supplementary data on four separate occasions since the cell toxicity test results were positive. 3. However, no problems were mentioned as far as clinical trial results were concerned, and there is no need to supply additional data on cell toxicity test results, which is only a preliminary stage to clinical trials. Furthermore, there are no written rules in the guidelines about supplying additional data based on results of cell toxicity tests, and the requests for additional data are being made arbitrarily by the medical devices examination council of the Central Pharmaceutical Affairs Council. 4. Therefore, the examination council should make no further requests for additional data based on unwritten guidelines, and should release examination results immediately. The ministry replied as follows: 1. When a chemical disinfectant is used on soft contact lenses, applicants are asked to provide cell toxicity test data on soft contact lenses which have been disinfected with a chemical disinfectant a specified number of times, and the data are evaluated by experts (members of the Central Pharmaceutical Affairs Council). 2. The experts evaluated the complainant's cell toxicity test data attached to the application for approval for using a new disinfectant, but since the results were positive, they requested data necessary for evaluating the irritation caused to the ocular membrane by the lenses in question and have been carefully evaluating the safety of the lenses. 3. The ocular membrane is a highly sensitive organism, and since careful evaluation is required, the complainant was asked to provide raw data on tests already performed, in order to fully evaluate safety. This is neither a request for conducting additional tests, nor is it an arbitrary request. 4. In any case, when safety was evaluated on the basis of the data already provided, the council reached the conclusion that there were no problems with granting approval, and this was done on February 7, 1999. |
||
| Classification of Processing | A | Directions | II-a IV |
| Remarks | |||