2019 Volume 72 Issue 1 Pages 55-79
In Japan, antibiotic products, like vaccines, had been regarded as biological preparations. This is due to the fact that penicillin, the first antibiotic product, was a mixture of natural compounds produced by a microorganism. As a consequence, antibiotics were controlled under specific “minimum requirements” with special attention given to health and hygiene.
Individual “requirements” for antibiotic products, such as “The Minimum Requirements for Penicillin” enacted in May of 1947, and others, were compiled into “The Minimum Requirements for Antibiotic Preparations” in March of 1952. These were later modernized to “The Minimum Requirements for Antibiotic Products of Japan; MRAPJ” in August of 1969 by conforming to amendments of “The Japanese Pharmacopoeia; JP” and international scientific standards.
Quality control in Japan, based on the MRAPJ and national certification of antibiotic products, had prevented the distribution of low-quality preparations and even forgery products. As a result, high-quality preparations were used clinically for the treatment of life-threatening infections or neoplastic diseases and eventually contributed to maintaining the health of the population. It can further be adduced to be one of the contributing factors for the expansion of the average lifespan of Japanese(by approximately 31 years for women and 28 years for men)during the period from 1947 to 2000.
For medicinal products, quality standards and methods of testing are principally provided in the JP based on Article 41 of the Pharmaceutical Affairs Law. The MRAPJ, based on Article 42 of the Law, underwent three extensive revisions (in 1982, 1990, and 1998) in accordance with the amendments of the JP. In some exceptional cases novel methods of testing were adopted by the MRAPJ ahead of the JP. On the other hand, up to 63% of the entities listed in the 1998 MRAPJ were manufactured via chemical synthetic processes and thought to have low necessity for controlling care with regard to special attention under the category of health and hygiene. In 1999, an administrative decision was made to integrate the MRAPJ into the JP and the work of transferring the monographs of antibiotic products from the MRAPJ to the JP started in 2000.
In this report, we describe the pharmaceutical and historical aspects, details and characteristics of the quality control of antibiotic products in Japan from investigations and analyses on enactment, and the subsequent amendments of the MRAPJ. This particular report will also introduce the integration work up to its preparation stage, but details regarding the integration of the MRAPJ into the JP will be discussed in our following article.
