Pilot Project Of MAH(Marketing Authorization Holder) In Zhangjiang Biotech & Pharmaceutical Base

This paper dose a comparative analysis of the drug marketing system between China and some foreign countries, and conducts a literature review and questionnaire survey according to Zhangjiang Biotech&Pharmaceutical Base’s internal and external conditions and the demand of the industrial development. Based on these studies, the paper discusses the feasibility and necessity of starting the pilot project of Marketing Authorization Holder(MAH) system in Zhangiiang Biotech&Pharmaceutical Base, and also proposes the corresponding planning and implementation of safeguard measures.The researches show that, MAH system can effectively reduce the duplication of manufacturing, improve the utilization rate, promote the pharmaceutical industry specialization of production equipment, and provide clearer legal liability. Compared with current "bundling" management system in China, MAH system is more scientific and reasonable. Zhangjiang Biotech&Pharmaceutical Base has formed a complete biological pharmaceutical industry chain and innovation clusters, and is one of the very few bases in biomedical field that has the most concentrated research institutions, the strongest ability of innovation, and the most prominent achievements. It provides a stable industry environment, a supply of highly qualified professionals and a favorable external environment for the pilot MAH system. The establishment of MAH system in Zhangjiang Biotech & Pharmaceutical Base helps the industry’s rapid growth and sustainability, and also meets the demands of more motivated researchers, higher rate of industrialization, and better allocation of pharmaceutical production and resources. So it’s very feasible and necessary.Adopting a new system, Zhangjiang Biotech&Pharmaceutical Base will face many challenges during this process, like pharmaceutical quality control, post-marketing drug safety management, and protection of consumers’ rights. Zhangjiang Biotech&Pharmaceutical Base should promptly seek government support of all relevant departments to actively promote the pilot MAH system. With the adoption of the new version of GMP in China, it should actively seek support and corresponding protection measures, focus on releasing the pharmaceutical contract manufacturing, speed up industrial chain integration, promote the pharmaceutical industry R&D innovation and transformation of scientific and technological achievements, and advocate the optimal allocation of resources and the adjustment of industrial structure. So that Zhangjiang Biotech&Pharmaceutical Base could continue to bear the good demonstration and leading role of China pharmaceutical industry’s sustained and rapid development, and contribute to the whole China pharmaceutical industry’s prosperity and long-lasting healthy development.