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China’s Marketing Authorization Holder (MAH) System

One of the breakthroughs the MAH system has brought to China’s pharmaceutical industry is that a drug marketing authorization holder no longer has to be the manufacturer.Since the law took effect in 2019, the MAH system has been implemented on every pharmaceutical companies seeking drug registration in China.

Hence, it is necessary for pharma companies pursuing development in the Chinese market to know the MAH system.

This article aims to help pharma companies, especially international drug makers, to understand:

  1. MAH’s Definition
  2. Requirements for Becoming an MAH
  3. MAH’s Rights
  4. MAH’s Responsibilities
  5. Regulations on MAH Entrusting Product Manufacturing to Others
  6. Transfer of Marketing Authorization (MAH Change)
  7. Documentation Requirements for MAH Change
  8. Impacts of MAH System on International Companies in the Chinese Market
  9. BaiPharm Offers MAH Consulting Services to International Companies.

BaiPharm offers the latest pharmaceutical news, in-depth analysis and professional consultancy services. BaiPharm offers a full portfolio of China NMPA compliance consulting services, such as product registration service, registration strtegy, GMP compliance service,pharmaceutical & Medical translation service, local agency support and customized training.

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