Provisional Translation
| OTO No. | 347 | Classification | MHW-177 |
|---|---|---|---|
| Date of Acceptance | February 1, 1988 | Ministry/Agency Receiving Complaint | Economic Planning Agency |
| Responsible Ministries | Ministry of Health and Welfare | Related Laws | The Pharmaceutical Affairs Law |
| Complainant | Japan Trade Association (proxy complaint) | Exporting Countries | USA |
| Subject | Concerning, the import of pharmaceutical ingredient for the manufacture of pharmaceuticals, 1. Exemption from application of the Pharmaceutical Affairs Law. 2. (1) Approval of entrusting the preclinical tests to a third party. (2) Expansion of acceptance of import approval applications not only by the governor of the prefecture where the head office of importer is located but also by the governors of prefectures where branch offices of importer are located. (3) Simplification of the application requirement for the tests repeated three times with three samples and for documentation showing the production process for applications for products which are not listed on the Standard for ingredient. |
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| Details of Measures | 1. It was replied that it is impossible to waive application of the Pharmaceutical Affairs Law in Japan, given that quality control at the raw material stage is clearly related to quality control for the final product, but that approval is not required for ingredients that have been widely used over a long period of time and that are listed in the Japanese Pharmacopoeia and for which quality standards are set taking account of variations if manufacturing methods, assuming they are manufactured to Japanese Pharmacopoeia standards. 2. (1) It was replied that not only can an importer delegate testing to another testing facilities of his own or to a testing organization as designated by the Minister of Health and Welfare but that the importer may attach data from tests conducted by the manufacturer in export, country if said tests have been conducted in conformity with Japanese standards. (2) It was replied that, while approval authority is delegated to the prefectural governor, it is felt inadvisable to broaden the scope of areas where application may be made to include prefectures where the company has branch offices because that would in turn require that each prefecture then check with the other prefectures that might be involved and that this complication might create further delays in procedures. (3) It was replied that the only information that must be appended to the application are the summary data from the tests repeated three times with three samples, and that the raw data are not required, as well as that the manufacturing method need only be concisely explained in the column for manufacturing method of application form and that no production method form is required. |
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| Classification of Processing | 1. D 2. (1) Ca, (2)D, (3)Ca |
Directions | 1. III 2. (1)II-a, (2)II-a, (3)II-a |
| Remarks | |||