More than 300 professionals gathered at the recent China Marketing Authorization Holder (MAH) System Summit to learn from government agencies, life science research and drug development scientists, and drug development and manufacturing organizations based on their experience within the initial months of the MAH pilot program. The program, launched in August 2015, is testing new regulatory strategies to speed creation of life enhancing therapies in China.
The summit was co-hosted by the Shanghai Jinshan District Municipal People’s Government, Shanghai Municipal Food and Drug Administration, and the Science and Technology Commission of Shanghai Municipality, and co-organized by Jinshan Industrial Park Administration Committee, Jinshan District Caojing Town Municipal People’s Government, WuXi AppTec, and STA Pharmaceutical.
The event set the stage for 10 speakers from government agencies, including the China Food and Drug Administrations, US Food and Drug Administration, and Shanghai Jinshan District, as well as industry representatives, to elaborate on the goals and progress of the pilot system.
The district agencies showcased the pro-business and technology boosting gains the pilot program is bringing, while the food and drug administrations discussed the mutual goal of ensuring patient safety while facilitating faster access to life changing therapies. District agencies also explained how a liability insurance program helps protect patients and support applicants.
“The Market Authorization Holder System is a critical component of the broader drug evaluation and approval reform in China. This program will boost the new drug innovation ecosystem in China, accelerate the drug approval process and optimize resource allocation,” said the leader from the CFDA.
Regulatory agencies from both the US and China emphasized the need for coordinated and predictable paths toward drug approvals “make sure products are treated equally when there are equal risks and equal complexity associated with their production,” noted Dr. Leigh Verbois, US FDA Country Director, China.
“There must be a regular, effective communication…if we solve the problem up front, there is less risk for the patients… this is our common goal.” said Ms. Hua Zhang, Associate Director, Shanghai Center for Drug Evaluation and Inspection.
A panel discussion composed of industry and regulatory leaders, including some of the early participants in the MAH pilot program, such as Hua Medicine, Hutchinson MediPharma, Johnson & Johnson, Merck and WuXi STA provided know-how and tips.
Panelists included Dr. Jonathan Liu, China Head PDMS, Johnson & Johnson; Dr. Zhenping Wu, Senior Vice President, Pharmaceutical Sciences, Hutchinson MediPharma; Dr. Li Chen, CEO, Hua Medicine; Ms. Hua Zhang, Associate Director, Shanghai Center for Drug Evaluation and Inspection; Dr. Minzhang Chen, CEO, STA Pharmaceutical; Dr. Zhihong Ge, Associate Vice President, Global Development Quality, Merck; and moderator Dr. Steve Yang, Chief Business Offices and Chief Strategy Officer, WuXi AppTec.
Dr. Li Chen of Hua Medicine commented on the implications of becoming a MAH license holder, “This is a right, an obligation, but also accompanied by responsibility requiring a change in the whole company from the president to the following staff.”
One of the most important aspects of the implementation of the MAH system is the potential to reduce duplication of construction. Previously, R&D institutions and researchers in order to maintain control of their invention had to build a manufacturing facility; now they can take full advantage of the existing excess capacity.
STA Pharmaceutical (STA), a WuXi AppTec company, may be more representative in this regard. Dr. Minzhang Chen, CEO of STA, remarked that so far STA has supplied more than 40 phase III clinical and commercial projects to global pharmaceutical and biotech companies, most of which are for global markets since China’s MAH policy was just initiated a year ago. “In the past, China has had many incubators to support the discovery of new drugs. Through the successful implementation of the MAH pilot system, we hope that many CMOs such as STA will become the platform to launch many new drugs in China.”
“MAH is an opportunity in that now it is not necessary to expend a lot of money to build factories, you can pass to the trustees to help produce, for our R&D this provides a lot of convenience. But this pressure is also the responsibility,” said Dr. Zhenping Wu, Senior VP, Pharmaceutical Sciences, Hutchinson MediPharma.
The solution to this burden of responsibility, according to Dr. Zhihong Ge of Merck, is choosing core strategic partners and establishing strong communication.
A vibrant Q&A followed both the speeches and panel and continued at the closing networking reception.