New Pharmaceutical Regulations in China Tighten MAH Requirements

Changes to pharmaceutical registration regulations in China that went into effect July 1 make clear that Market Authorization Holders designated by the country’s regulatory authority to market or distribute a product are responsible for the safety, quality, and efficacy of that product through its entire life cycle. The changes, announced in June, are designed to bolster safety requirements for clinical trials, encourage the development of generic drugs, limit fraud in clinical data, and expedite the pharmaceutical approval process.

Under the new regulations issued by China’s National Medical Products Administration to improve the safety and accessibility of much-needed drugs, holders of such MAH authorizations must obtain a drug manufacture license, even if they are not producing drugs, to ensure drug quality is upheld through qualified personnel and policies.