Registration in Japan

Only after the initial assessment by the examiner has been successfully completed (which may require working off a long deficiency list), the application is reviewed by specialized subcommittes. The initial examiner remains the only contact person for the applicant. However, there is a possibility for the applicant to receive direct instructions from the scientific subcommittee during a very short hearing . The standard period for the evaluation of a dossier by the PAB is set at 18 months. This appears to be a reliable estimate. 

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We focus on the requirements for registration in Japan. Thus, we provide information that considers the peculiarities of the requirements for the JP heavy metals test at the method development process. The compendial descriptions and relevant ICH guidelines in relation to this chapter are listed in the reference section. The principles for the validation requirements discussed in this chapter can be applied to heavy metal testing in general. 

Tandospirone, an other azapirone is awaiting registration in Japan [3]. Flesinoxan is in Phase III, clinical development for use in anxiolytic disorders. Flesinoxan has in contrast to the azapirones a favourable pharmacokinetic profile. 

A further specialist with fungicidal activity against several sclerotial diseases of rice plants is diclomezine. It was discovered in 1972 by Sankyo [54] and got its first registration in Japan in 1987. 

Ramatroban is a thromboxane-prostanoid receptor antagonist. Late-stage clinical studies in patients with allergic rhinitis showed symptom improvement. This compound is in the process of registration in Japan (88). 

Japan. In Japan, registration of dmgs for aquatic species requires the same data as those required for dmgs on other animals. The Ministry of Agriculture, Eorests, and Eisheries and the Ministry of Welfare control the use of chemicals in aquaculture in Japan (17). The preclinical data requirements include product chemistry, toxicity (acute, subacute, special) using rats and mice, safety to target animals, and metaboHsm. The requirements for clinical data include avadabiHty and residues. As of July 1990, more chemicals were registered for aquacultural use in Japan than in any other country (Table 4). 

To commercialize agricultural end-use products in Japan, applicants are required to submit appropriate data to MAFF. The data required for registration are summarized in this section. 

Tolerances for pesticide residue and/or standard withholding registration of neonicotinoids in Japan are shown in Table 1. 

All use of chlordane was banned in Norway in 1967 (Ingebrigtsen et al. 1984). In August 1975, the USEPA issued its intent to suspend registrations and prohibit production of all pesticides containing heptachlor or chlordane, based on evidence of carcinogenicity (Glooschenko and Lott 1977). On July 1, 1983, chlordane use was prohibited in the United States for any purpose except to control underground termites. A similar situation exists in Japan (Ohno et al. 1986 Tojo et al. 1986). 

Yakuji Nippo, Ltd. (1991). Drug Registration Requirements in Japan. Yakuji Nippo, Ltd., Tokyo, Japan. 

In 1996, the VICH program was officially launched among the European Union, Japan, and the United States (52). Among the objectives of the VICH is to provide a forum for a constructive dialogue between regulatory authorities and the veterinary medicinal products industry on the real and perceived differences in the technical requirements for product registration in die three jurisdictions, with tlie expectation that such a process may serve as a catalyst for a wider international harmonization. VICH should identify areas in which modifications... 

To provide a forum for constructive dialog between and among regulatory authorities and the pharmaceutical industry on the real and perceived differences in the technical requirements for product registration in the EU, the United States, and Japan... 

The production of chlordane was reduced from. 3.5 to 4.0 million pounds in 1986 to 100,000 to 1 million pounds in 1991 (ATSDR, 1994a). More than 63 million kg of chlordane were produced and used in the United States, mostly after 1960 before sales and its use were suspended in 1988 (Dearth Hites, 1991a,b). Restrictions were imposed on the use of chlordane in 1979 because of its potential human carcinogenicity. After this time chlordane was used mainly for underground termite control and in building construction (Dearth Hites, 1991a,b). In Japan, chlordane was only permitted for the control of termites and powder post beetles (Miyazaki et al., 1980). USEPA cancelled its registration for commercial... 

EC 1907/2006). As the name implies, it deals with the registration, evaluation, authorization, and restriction of chemical substances. The new law entered into force on 1 June 2007. The aim of REACH is to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances.156 The ELV (End of Life Vehicles) directive aims to reduce the amount of environmentally unfriendly waste from ELVs. Similar initiatives are well developed in Japan and are evolving in China157 and many other countries. In the United States, at the state level, some states (for example, Maine and California) are adopting material restrictions on PVC plasticizers and certain brominated FRs. 

Registration Antibiotics Diseases Amounts used in Japan (1974) ... 

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