MAH:Deep System Reform to Promote Pharmaceutical Product Innovation

The Meloxicam Tablets applied for by Shanghai Fosun Pharmaceutical as a group MAH was approved by China Food and Drug Administration (CFDA) on February 27, to become the first marketed variety with MAH and manufacturer separated in Shanghai. Since the pilot work was proposed in 2015, the MAH system has achieved substantial progress, which is a significant reform in the pharmaceutical product registration system of China and has important influences on the future development of the entire Chinese pharmaceutical industry. Here I want to focus on introducing the system’s promotion to pharmaceutical product innovation.

• Policies relating to MAH

Marketing Authorization Holder is called MAH for short. The Decision on Authorizing the State Council to Carry out Pilot Program of Marketing Authorization Holder System in Some Places and Relevant Issues was passed in April 2015; the Plan for the Pilot Program of the Marketing Authorization Holder System was issued by the General Office of State Council of China in June 2016; CFDA issued the notice on advancing relevant matters of pilot work of Marketing Authorization Holder system in August 2017.

• Current pharmaceutical product registration system in China

The current pharmaceutical product registration system in China has the management mode bundling marketing authorization and production license, namely, the pharmaceutical product marketing authorization (pharmaceutical product approval number) is only issued to manufacturers with Pharmaceutical Production License, and pharmaceutical R&D institutions and researchers are not qualified for the pharmaceutical product marketing authorization.

• The "bundling system" restricting pharmaceutical product innovation

As is well-known, pharmaceutical R&D requires heavy investment but has low success rate, which was the main reason that the Chinese pharmaceutical industry was based on generic drugs at the early stage. In the context of "bundling system", there are two ways for pharmaceutical R&D institutions or researchers to get their scientific achievements to the market to become real products: investing and building factories or technology transfer. Pharmaceutical factory stands for an asset-heavy industry, with too high investment cost and big management difficulty, therefore, the former is not much feasible; the latter can convert research achievements into revenue within a short time, but the revenue is often limited, not consistent with early-stage R&D investment and revenue expectation, therefore, it is insufficient to become the impetus for product optimization and innovation research.

As introduced by Xu Jinghe, Director of Department of Legal Affairs of CFDA, the disadvantages of the "bundling system" gradually appear with the rapid development of the Chinese pharmaceutical product industry and progressing of the pharmaceutical product regulation idea and system, which are not conductive to encouraging drug innovation and resource allocation. Deep system reform is urgently needed to break the deadlock, to effectively improve pharmaceutical product quality and promote pharmaceutical product innovation.

• MAH system to promote pharmaceutical product innovation

MAH system gives the pharmaceutical R&D institutions or researchers the initiative to turn research achievements into products. Pharmaceutical R&D institutions or researchers can file drug clinical trial applications or pharmaceutical product marketing applications as pharmaceutical product registration applicants, and when the applicants obtain the pharmaceutical product marketing authorization and pharmaceutical product approval documents, they can become the MAH; after pharmaceutical R&D institutions or researchers become holders, they can entrust pharmaceutical factories qualified for production to conduct market-based production of products, which increases researchers’ control over research achievements and returns.

MAHs shall assume certain responsibilities while being conferred authority. Holders are responsible for the whole chain of pharmaceutical production and sales as well as pharmaceutical product lifecycle management, and assume all the legal liabilities for pharmaceutical product preclinical studies, clinical trials, production, distribution and delivery, and adverse reaction monitoring, etc., which is a great challenge to researchers, involving selection of enterprises entrusted for production, R&D-to-production-process conversion and implementation, and production quality management, etc. Researchers are often good at research, but bad at production and marketing which are entrusted to third parties, leading to low controllability and increased management difficulty, which will be a problem.

In conclusion, MAH system offers a new path for the pharmaceutical R&D institutions or researchers to convert research achievements into products, has an enormous breakthrough in terms of system compared to the "bundling system", greatly improves initiative of researchers, and promotes pharmaceutical product innovation, however, there are many things to explore and constantly improve, which requires the joint efforts of the entire pharmaceutical industry for the promotion.

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