With the enforcement of special provisions of the division license system in April 1994, a new market was formed for contract pharmaceutical manufacturing. Moreover, the implementation of the Revised Pharmaceutical Affairs Act in April 2005 (to relax regulations on pharmaceutical manufacturing) made complete outsourcing possible in the pharmaceutical manufacturing industry, which has led to a rapid increase in contract manufacturing undertaken by contract companies. In recent years, the business environment surrounding pharmaceutical companies―supporters of the pharmaceutical industry―has experienced significant changes, and the borderless and global competitions have required leading companies to focus on the overseas expansion of capital (growth in sales and exports) and the research and development of new medicines; consequently, in the field of medicine manufacture, they have addressed improvements in efficiency through the effective use of outsourcing. After about four years of preparation, the Japan CMO Association (JCMOA) was established in November 2010 with 18 member companies. With the main aim of exchanging information on such areas as production techniques and contract manufacturing, facilitating open and honest discussions, formulating industry standard guidelines, and carrying on manufacturing technologies, we have pursued our studies to further improve the level of our activities and services.
The association has grown and now has a total of 48 member companies (full member companies: 27, supporting member companies: 21), and we will aim at further expansion. JCMOA activities are carried out and promoted primarily through the following four committees―the Policy Committee, Technology and People Development Committee, Quality Assurance Committee, and Public Relations Committee. To make the JCMOA a more robust organization, we will encourage mutual efforts and studies toward a resolution of the issues and challenges common to pharmaceutical manufacturing, promote an understanding of the roles and contributions of contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs), and promote technical cooperation among member companies.
Client companies’ expectations of the outsourcing are reductions in new investments, lower production costs, and risk distribution, and the selection criteria for contract companies include advanced manufacturing technologies, firmly established quality assurance systems, corporate credibility and reputation, and factory scale. Some of the issues and challenges to be addressed by contract pharmaceutical manufacturing companies are to reinforce manufacturing facilities, improve technological capabilities, secure and develop manufacturing staff, accelerate overseas expansion, and enhance pharmaceutical development. New business developments in the growth segment of the pharmaceutical market, such as cancer treatment or antibody drugs and other biopharmaceuticals, require enormous risk-taking, for example, large-scale capital investments and investments to maintain high technological capabilities. At present, the number of member companies that have entered this growth segment is limited, and to support members willing to enter this new growth segment, we are providing information collected from relevant government agencies and those companies that have already entered the segment, in addition to holding periodic study group sessions to address the doubts and concerns of the member companies. We will also strengthen our efforts for overseas expansion.
As a professional in the field of contract pharmaceutical manufacturing and contract pharmaceutical development and manufacturing, we will continue to provide support for the pharmaceutical industry to member companies that support pharmaceutical manufacturing and to outsourcer and pharmaceutical companies, thus contributing to the protection of people’s health and safety in Japan and furthering the revitalization of the Japanese economy as an association of the Japanese pharmaceutical industry.
June 1, 2020