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PMDA: Basic Principles on Global Clinical Trials >>

The documents are presented here for information purpose only and are included here without comments or annotations (in preparation). This English-language file is an provisional translation of the final Notification No. 0928010 dated September 28th 2007 and is intended to use as a reference when considering global clinical trials.

Note: The documents included here are bilingual - in Japanese and English. The files linked below are identical in term of contents, however the visitors having Acrobat enabled to display Japanese characters could download either text file.

Text in English    |   Original text in Japanese of Notification No. 0928010    


Description points of the certificates delivery application (for P. R. China) for products such as cosmetics, etc. >>

On December 28, 2006, the MHLW enforced new requirements for cosmetic products containing ingredients originating in P. R. China. The scope of the new requirements is to guaranty both safety (specifically to prevent import of products or materials with risk for BSE transmission) and  quality (against counterfeited products). Practical purpose of requirements is to reduce the numerous errors in filling the application documents, to remove the ambiguity in descriptions and to streamline the application procedure. Included in each files below are the main guidance documents from PMDA and 8 forms as attachments to the application form. The documents are presented here for information purpose only.

Note: The documents included here are bilingual - in Japanese and English. The files linked below are identical in term of contents, however the visitors having Acrobat enabled to display Japanese characters should download the text file, otherwise the Image file contains only facsimile images of the Japanese documents and it is viewable in any version of Acrobat.

Text file    |   Image file     



Third Report Regarding Promotion of Regulatory Reform >>

In December 2003 the The Council for the Promotion of Regulatory Reform made public its "Third Report Regarding Promotion of Regulatory Reform" - a comprehensive view on pending structural and functional problems in Japanese society, including the area of medical and health care.

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