China Boosts Regulatory Framework for Local Pharmaceutical Manufacturing
China's Drug Administration Law reforms, including the nationwide Market Authorization Holder (MAH) system, aim to boost foreign investment and streamline drug approvals. Challenges persist in cross-border manufacturing, IP, and regulatory compliance. The MAH system allows partnerships with local manufacturers or CMOs for quicker market access. Cross-border manufacturing is legally feasible but practically limited. Foreign companies have options to either hold the MAH or have a local entity do so. Recent regulations support local manufacturing of imported drugs, with priority review for originator drugs, addressing concerns like IPR protection and regulatory compliance.
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China's Drug Administration Law reforms, including the nationwide Market Authorization Holder (MAH) system, aim to boost foreign investment and streamline drug approvals. Challenges persist in cross-border manufacturing, IP, and regulatory compliance. The MAH system allows partnerships with local manufacturers or CMOs for quicker market access. Cross-border manufacturing is legally feasible but practically limited. Foreign companies have options to either hold the MAH or have a local entity do so. Recent regulations support local manufacturing of imported drugs, with priority review for originator drugs, addressing concerns like IPR protection and regulatory compliance.