Related Laws : The Pharmaceutical Affairs Law

674Relaxation of cosmetic regulations for CoQ10
673 Import procedures for veterinary drugs, etc
644 Prompt processing of an application for import approval of a quasi-drug that contains an existing ingredient as a new effective ingredient
636 Review of medical contents classification (L-carnitine)
635 Review of medical contents classification (L-carnitine)
616 Relaxation of regulations on in-vitro diagnostics
615 Relaxation of regulations on import approval and item change approval for medical instruments
606 Approval of color contact lenses
587 International harmonization of testing methods for contact lenses
586 Speeding up examination procedures for approval of contact lenses
578 Change in labeling method for cosmetics
564 Promotion of deregulation regarding cosmetics (hair dyes)
553 Approval of new ingredients for nail polish
520 Approval of continuous import of ear tags for identifying livestock
503 Simplification and international harmonization of application procedures relating to imports of stethoscopes
474 Import approval of closed-circulation anesthesia apparatus
472 Relaxing requirements for parallel imports of cosmetics
451 Simplifying approval of cosmetics containing liposome
450 Simplifying approval for quasi-pharmaceuticals
449 On speeding up the examination of antiseptics used in cosmetics
434 Clarification of the period required for obtaining approval for medical equipment and for the simplification and acceleration of this process.
397 Reconsideration of the regulation on the form (capsule) for health foods.
391 Concerning the import procedures for a hair dye,
1. Clarification of the procedures for quasi-drugs.
2. Reduction of the inspection time period and expense for quasi-drugs.
347 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.
346 Concerning the import of medical equipment,
1. Acceptance of the US clinical trial data and omission of the Japanese clinical trial date for products and systems that have been approved by the US Food and Drug Administration.
2. Exemption from attaching approval by the Ministry of Health and Welfare for domestic medical equipment returned for repair.
337 Exemption from the requirement for submission of list of ingredients for hand and body cleaner that has been approved as safe in USA, since it is feared that disclosure of ingredients may compromise proprietary information.
308 Permission to submit the notification of clinical trial design after customs clearance only in the case of raw drug for clinical trials.
307 Concerning import inspections for pharmaceutical and other products, exemption from submission of test results for every lot when a comprehensive report is submitted on inspection procedures and results.
306 Permission to move pharmaceutical and other products to bonded areas before the approval of their import
305 Approval for the same person to serve as supervisor for the drug seller and supervisor for the importer.
304 Adoption of the system waiving individual approval requirements for medical devices (artificial joints and the like) that uses the same material used, standards, and testing methods and differs only in size.
303 Permission to entrust tests except for organoleptic examination as required for the import/sale of pharmaceutical products to other testing institutions.
302 Elimination of the import approval product-by-product requiring only import sales licenses, concerning the import of pharmaceutical ingredients (except for new drugs)
301 Concerning the import of sight corrective ophthalmic lenses, simplification of the import procedures through exemption from the regulations of the Pharmaceutical Affairs Law.
300 Expedition of deliberation on the amendment of the standards pertaining to blood grouping serum, with dramatic expedition for minor amendments.
299 Automatic import approval for pharmaceutical products that are not listed in the Japanese pharmacopoeia when their ingredients meet the foreign pharmacopoeia standards and the finished product meets the Japanese approval standards.
274 Concerning import approval for cardiac pacemakers,
1. One request is made for all of the data needed for evaluation and processing.
2. Permission substituting single-chamber data or foreign-generated data for dual-chamber data.
269 On the import of medical equipment,
1. Permission as outside of the regulations for medical equipment, for the import of pressure transducers and transfusion sets that have been removed from their sterile packing.
2. Expansion of products, including this one, as importable on the customs authorities' go-ahead, though the Ministry of Health and Welfare entrusting such inspections to the customs authorities and that this product be added to the list of products importable on the customs authorities' go-ahead.
245 Approval of the parallel import of cosmetic soap by accepting the certificate issued from the British Government certifying that the cosmetic soap concerned is the same in kind with the products distributed in England, in view of the difficult to obtain the composition certificate from the manufacturer.
237 Permission to sell the Urina Tester (a measuring instrument of urine's specific gravity) to general consumers.
233 In the application for the import of a shampoo sold in the USA, etc., exemption from the obligation to submit its ingredients and volume data and relaxation of the standards for its structural equipment, etc.
230 Exemption from the submission of animal test data, etc. in the application for the approval of import of alcoholic antiseptic
221 Approval of import of Kumis Kutjing leaves products as a food.
209 Relaxation of the standards of structure and facilities concerning license for importing cosmetics.
198 Concerning the import of heart pacemakers, exemption from the obligation to make clinical trials again when the size, battery, etc. are changed.
196 Propriety of import of an article with anti-smoking effects as a food.
194 Concerning the import of the pregnancy test kits, simplification of the import procedure and propriety of its sale for household use.
180 Concerning the licensing procedure for importing of raw natural drugs, exemption from the obligation to describe the manufacturer's name.
179 Concerning the license for importing cosmetics, permission of the joint use of the test and inspection facilities.
178 Permission of the use or sale of high-priced medical devices imported for the purpose of clinical trials.
177 Concerning drugs, etc.,
1. Expansion of the scope of delegation of the authority to approve of them to the prefectural governors.
2. Simplification and expediting of the cosmetics licensing procedures.
3. Concerning the examination of the new drugs, etc., clarification of the instructions and expediting of the examination at the Central Pharmaceutical Affairs Council.
176 Simplification and expediting of the procedures for approval necessary be taken by the importer when the exporter changed the names of drugs, etc.
175 Concerning the application for the license for importing drugs, etc., simplification of the application documents in the case where the manufacturing license for drugs, etc. has already been obtained.
153 Propriety of importing a food deodorant cream as cosmetic
148 Concerning the import of cosmetics, propriety of foreign manufacture obtaining directly the manufacturers license under the Pharmaceutical Affairs Law, instead of the importers making application for the license.
135 Acceptance of ginseng tea in sachet (under 10g) or capsule as a food.
133 Concerning natural vitamin E,
1. Handling of products as a food in Japan which is sold in US as a food.
2. Handling of products as a food in Japan, irrespective of the content of natural vitamin E.
132 Permission to import Herbal Cigarettes
130 The adequacy of exporting cosmetics to Japan without informing the Japanese importers of their ingredients and quantity.
117 Permission of the import of bath soap.
116 1. Approval of use of hydrogen peroxide as a component of a permanent wave agent.
2. Approval of use of Imexines and Ionenes.
111 Simplification and speed-up of the procedures to approve a new medicine.
110 Expedition of the examination process and prompt notification in case the application content has any defect in the examination for permission of the import of a medical device (blood pressure manometer).
100 When a Japanese importer is changed concerning the import of the same cosmetic, the submission of some data is required and it takes 8-10 months to go through the necessary formalities. Simplification of this procedure.
99 Reconsideration for handling of Chamomile Tea as a foodstuff.
98 Reconsideration for handling of aloe drink as a foodstuff.
95 Request for the ingredient inspection in the applications for approval of import of sports massage oils of which ingredients are unknown.
90 Handling of liquid crystal forehead fever thermometer as general consumers but not medical equipment.
86 Expeditious issuance of import approval of Hemofiltration system and adoption in the medical insurance system of Hemofiltration medical treatment method using this system.
83 Expeditious issuance of import approval of metoo drugs (later-developed medicines which is identical to the already approved medicines), prompt adoption of these drugs in the medical insurance system, and acceptance of the foreign test data.
71 Concerning the import approval procedure for medical equipments,
1. Acceptance of the approval by the US Food and Drug Administration (FDA) that the product is substantially equivalent to products already on the market and that it is eligible for the 90-day prior notice system and acceptance of the US FDA approval for new medical equipment.
2. Acceptance of the test results made by the Underwriters Laboratories and European test organizations for the purpose of verifying compliance with the international standards (IEC Standards) on electric safety and acceptance of those at 100 volts.
3. With respect to performance data, acceptance of results tested at the foreign manufacturer's facilities outside Japan, and approval to use only one piece of equipment for testing instead of two or three.
64 Simplification of import approval procedure with respect to a new importer if he is dealing with medical equipment for which import permission has formerly been given.
25 Delivery of necessary import certificates for the export from USA of medical treatment equipments for test use.
18 Acceptance of data generated abroad (stability data and clinical test) for the import of in vitro pharmaceuticals.
15 Concerning the import of two dental equipment, the reason that it was difficult to obtain import license.
14 Simplifying the import testing procedure for plaster.
8 Permission of US hand cream to be displayed at the exhibition.
2 In the import of dental materials from abroad, the propriety of the import under the name of the representative of the group of dentist or that in a cooperative formula.
1 1. Delay in the customs clearance of first-aid kits attached to cars.
2. Delay in the customs clearance of fire extinguishers attached to cars.