Sterility assurance of microspheres.

The International Conference on Harmonization (ICH) provides a forum for constructive dialogues between regulatory authorities and the pharmaceutical industry on the real and perceived differences in the technical requirements for product registration in the EU, US and Japan. Achievement obtained so far is beyond expectation, having strong impacts both favorable and unfavorable on Japanese regulatory authorities and the pharmaceutical industry. The ICH guidelines are very science-oriented and little consideration seems to have been paid to the cultural and legal differences among the three regions. An example of such a difference is the interpretation of the guidelines between the US and Japan. In the US, they are generally recognized as good examples, whereas in Japan, they are usually taken as minimum and rigid requirements. A more flexible approach to guidelines will be necessary in the development of new dosage forms in Japan. In this paper, how to assure sterility of a new dosage form, that is, once-monthly injectable and biodegradable microspheres of Leuprorelin, a super agonist of LHRH, whose pharmaceutical development the author was in charge of at Takeda Chemical Industries, will be introduced.