Hello everyone, the topic I chose for this month is purely based on the two catchy words mentioned in the title, SHONIN and KYOKA. I was going through this book and suddenly I noticed a subheading DRUG REGISTRATION IN JAPAN. The Japanese constitutes the greatest consumers of pharmaceutical products "per capita" in the world. The three basic steps involved in Japanese Regulatory system are: * Approval (Shonin) - for manufacture or import of drug * A License (Kyoka) - mandatory for trading pharmaceutical products * Price of the product must be set. The chief governing body in Japan, Pharmaceutical Affairs Bureau carries out the drug dossier evaluations. This usually takes around 18 months. The terms and conditions, rules are very much similar to US. The process begins by submitting applications with full and correct details implying the drug product. The application is reviewed by the single regulatory examiner to ensure its conformance to guidelines. Later it is clearly inspected by Specialists Subcommittee. Essentials conforming to quality, efficacy, and safety must be clearly checked and reviewed prior to approval. Another interesting thing is that few clinical trials must be carried out in Japan and the results must be recorded accordingly. This is because of individual variations living in Japan, US or any other country. Moreover the pharmaceutical products available in Japan contain less dose relatively compared to other countries. THIS BLOG IS FREE OF PLAGIARISM. Ref: Pharmaceutical Biotechnology- Concepts and Applications by Gary Walsh, John Wiley & Sons Ltd, 2007 edition, Page No: 100.