Japanese requirements, drug guidelines

Japanese Ministry of Health and Welfare (MHW). (1989). Revised Guidelines for Toxicity Studies Required for Application for Approval of Manufacturing/Importing Drugs. Ministry of Health and Welfare Tokyo, pp. 37—48. 

Notification No. 698, Pharmaceutical Affairs Bureau, Japanese Ministry of Health and Welfare, Tokyo, 1980. Draft Policy to Handle Stability Data Required in Applying for Approval to Manufacture (Import) Drugs and Draft Guidelines on Methods to Perform Stability Test. Ministry of Health and Welfare The First Evaluation and Registration Division, Pharmaceutical Affairs Bureau, 1990. 

The features of a particular biopharmaceutical are the result of the basic characteristics of the molecule such as amino acid sequence and three-dimensional structure as well as the specihc production, purihcation, formulation, and storage conditions (Box 12.4-2). To produce a biopharmaceutical of constant required quality, a company also needs the experience and the in-house standards to apply the methods used to analyze the structure of a given product. There are various guidelines of the European Medicine Evaluation Agency, the Food and Drug Administration, the Japanese Ministry of Health and Welfare, and the ICH, which require manufacturers to show that they control the production process and are capable of reproducibly manufacturing batches that not only meet product specih-cations, but also conform to the dehnition of the product as established through full characterization. Modihcations of the established process are only accepted if the manufacturer can show that the product of the new process is comparable with the initially manufactured product. Comparability studies include revalidation of... 

---