Guide
Han Kun Law LLP: Strategic Insights for the Localization of Pharmaceutical and Medical Device Manufacturing in China
In recent years, an increasing number of multinational pharmaceutical and medical device companies have been exploring local manufacturing options in China. Many of the licensing transactions that have surged in recent years also involve technology transfer and plans for the future localization of imported products.
The trend is driven not only by the need for cost control and supply chain optimization but also aligns with China's policy incentives for industrial localization. Companies can pursue localization through various pathways, such as establishing their own production facilities, collaborating with contract manufacturers, or partnering with local licensees through licensing arrangements.
However, China's regulatory framework for drug and medical device localization remains complex and constantly evolving. Companies often encounter challenges related to registration classification, application requirements, Marketing Authorization Holder (MAH) and manufacturing arrangements, as well as the recognition of originator drug status, etc. Han Kun takes a deep dive into this area.