As a part of the drug evaluation and approval reform in China, the enhanced Marketing Authorization Holder (MAH) system is now law in China nation-wide. This law eliminates a significant hurdle for drug developers in registering and marketing an innovative drug in China.
Up until August 2019, the marketing authorization of a drug was tied to the specific manufacturing facility. Only the physical drug manufacturer could obtain marketing authorization. There was no clear regulatory path to outsource manufacturing of drug product. Historically this rule had a positive impact on improving drug traceability and quality. However, for smaller local and international biopharma companies, the lack of MAH posted a significant challenge when registering a product in China if the production is outsourced to a contract manufacturer (CMO).
A couple of years ago, FMD handled an IND application for a US-based biotech company. The key issue was the manufacturing location change from a smaller company-owned facility to a CMO. There were a number of back and forth with the regulators.
In, 2016, China’s State Council piloted a drug Marketing Authorization Holder (MAH) System in ten major cities and provinces, including Beijing, Shanghai, Jiangsu, and Tianjin. The pilot program allowed research organizations and individual researchers to hold a marketing authorization without owning any manufacturing facilities.
The new drug administration law, approved in August 2019, gives flexibility to global sponsors large or small to market a drug in China. Now, pharma companies will be able to apply for marketing authorization approvals and contract out drug manufacturing to a CMO. This law is beneficial to many stakeholders and will speed up drug development timelines.
Related to this issue is the classification of domestic vs. imported. China drug law classifies drugs into Domestic and Imported categories based on the physical location of the manufacturing facility. If you need to relocate the facility across China’s border during your development cycle, a brand new IND is required. This has a significant impact on time. Clearly laying out a development with realistic timeline is critical. For instance, if you are considering out-licensing, or planning to conduct clinical trials in China, you will be better served by understanding the time impact of manufacturing in your current facility vs. tech-transfer to China.
Also, worth noting the Enhanced MAH system for medical devices is now being tested 21 provinces in China. Similar to the drug pilot project, this enables medical device scientific research institutions and researchers to become MAHs.
About the Author:
Lei Liu is the VP of Regulatory Affairs of FMD. She has been working in the regulatory affairs arena for over 10 years. Over the past decade, she led teams to successfully execute over 150 registration cases for biopharma companies. She has includes MRCT application in China simultaneously with global trial, strategy consultation of China-Asian and China-US combined trial submission
About FMD K&L:
FMD is a full service clinical CRO focusing on innovative drug development. With its 1,700 employees in 20 offices in China, US, Japan, India, UK, The Philippines and Armenia, FMD has helped global drug developers advance clinical development for 12 years.
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