抄録
Recent information on GMP has been described, which includes the followings: product recalls in 2006 in Japan, memorandum of MHLW with EU on MRA, brief report on the revised medium-ranged plan of PDMA, brief reports on the GMP discussion meeting in Yamaguchi Prefecture, on the discussion meeting on biotechnology in Ohita Prefecture, and on the discussion meeting sponsored by the Pharmaceutical Technologists Association in Saga Prefecture. Several guidelines issued by EMEA were exposited. Product recalls in U.S. in 2006, which have been posted on FDA web-site were analyzed with respect to their recall classification and reasons. The report on India moving its centralization of regulations on medicines and medical devices was made shortly.
