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STA: Pilot program to enable CMO use in China is a 'huge opportunity'

Melissa Fassbender

By Melissa Fassbender

27-Jul-2017

China's MAH pilot program was launched in August 2015. (Image: iStock/Frankljunior)
China's MAH pilot program was launched in August 2015. (Image: iStock/Frankljunior)

The Chinese pharmaceutical industry sets a positive outlook for regulatory harmonization as its Marketing Authorization Holder pilot program progresses.

Recently, more than 300 gathered at the China Marketing Authorization Holder (MAH) System Summit to discuss the progress of the MAH pilot program.

The summit was organized by WuXi AppTec and STA Pharmaceutical, a WuXi subsidiary, in conjunction with the Shanghai Municipal Food and Drug Administration and the local government of the Jinshan District of Shanghai.

According to STA, discussions at the MAH symposium revolved around the progress of the new MAH system in streamlining drug approvals and indicated a positive outlook with the program.

The program is currently being piloted in ten provinces and municipalities across China. It’s guidelines draw from other foreign systems, such as the US Food and Drug Administration’s (FDA), and look to catalyze the research and development of innovative drugs in China.

The pilot allows more stakeholders to be part of pharmaceutical development,” an FDA representative told Outsourcing-Pharma.com in a written comment.

Notably, the pilot program enables drug license holders to use a third party manufacturer instead of building GMP manufacturing capabilities in house as was previously required.

This prevented researchers and development organization, critical stakeholders in drug development, from participating in innovation or financially benefiting from their research,” FDA explained.

Dr. Minzhang Chen, CEO of STA Pharmaceutical, a WuXi AppTec subsidiary, told us at a conference earlier this year that the concept of a contract manufacturing organization (CMO) did not previously exist in China for the domestic market. “In China, basically, you were not allowed to use a CMO,” he said.

Instead, pharmaceutical companies in China have had to make the drug themselves, Chen explained. “So, this slowed down innovation because new companies don’t have the resources.”

Under the new MAH pilot program, however, the use of CMOs is allowed in some areas.

So now pharmaceutical companies can come to us. In theory, it’s a huge opportunity for us,” added Chen.

According to the FDA, the new MAH system also emphasizes that individuals and organization must have a quality management system to address product quality and risk communication.

Dr. Leigh Verbois, Director of the China Office at the US FDA, called the pilot’s success a step forward in the globalization of drug regulation during the Summit which was held in June.

Pharmaceutical regulatory harmonization helps ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner," an FDA representative added.

The China FDA also recently announced its membership in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Additionally, the agency published four new draft policies earlier this year with proposed changes to drug, medical device, and clinical testing regulations. 

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