What is MAH policy in China?

In China, the Marketing Authorization Holder (MAH) system refers to a policy shift in the regulation of pharmaceutical products. Traditionally, pharmaceutical companies in China were required to obtain a drug production license and a drug distribution license separately. However, the MAH system, which was introduced to align with international practices, allows a separate legal entity to be responsible for the marketing authorization of pharmaceutical products, including new drug applications, rather than the actual manufacturer or the license holder.

Key aspects of the MAH policy in China include:

Marketing Authorization Holder: 

Under the MAH system, an entity or organization can be designated as the MAH, assuming the responsibility for applying for and holding the marketing authorization for pharmaceutical products. The MAH is responsible for ensuring compliance with regulatory requirements, including pharmacovigilance and post-marketing surveillance.

Decoupling Manufacturing and Marketing Authorization: 

The MAH system decouples the responsibility for manufacturing pharmaceutical products from the responsibility for obtaining marketing authorization. This allows for greater flexibility in the supply chain and promotes innovation and competition within the pharmaceutical industry.

Flexibility and Innovation: 

The MAH system is designed to encourage innovation and investment in the pharmaceutical sector by allowing companies to focus on research, development, and marketing while engaging third-party manufacturers for production.

Regulatory Oversight: 

The introduction of the MAH system has led to the establishment of regulations and guidelines governing the roles and responsibilities of MAHs, including requirements for quality management, adverse event reporting, and compliance with good pharmacovigilance practices.

Transition Period: 

The implementation of the MAH system in China involved a transition period during which existing drugs were given time to adjust to the new regulatory framework. New drug applications have been required to comply with the MAH system since its introduction.

The MAH system in China reflects the country's efforts to align its pharmaceutical regulatory framework with international standards, promote innovation, and enhance the competitiveness of its pharmaceutical industry. It is important for pharmaceutical companies operating in China to understand and comply with the specific requirements and obligations associated with the MAH system to ensure successful product registration and commercialization.