MAH service
Providing full-life cycle solutions for MAH project

MAH in China

China's Market authorization holder system, or "MAH system" for short, is a major reform and innovation in China's pharmacutical product regulation from pilot to legislation, changing the model of bundling pharmacutical product approval number with manufacturer.


Manufacturing License of pharmaceutical products (B License) is evidence that R&D entity has been qualified for production of pharmaceutical products, which is also one of necessary files for registration application of pharmaceutical products.


Along with China's continuous deepening of reform of pharmaceutical companies and adjustment of industrial structure, many pharmaceutical companies have started to focus on whole industrial chain establishment, core competitiveness enhancement and pursuit of high-quality development strategies. Many pharmaceutical companies are accomplishing business goals such as scaling up, integration and internationalization through M&A.


Canny is dedicated to QMS establishment, talent structure optimization, guidance for drug manufacturing license application along the whole life cycle of pharmaceutical products for MAH, as well as the implementation services for the audit of contracted faclity/material vendors/third-party service providers, and DD research before M&A.

CANNY-Your Trustworthy Consultant for Drug Regulatory Compliance!
  • 25 years
    of professional consulting experience in the pharmaceutical industry
  • 700 +
    GMP certification projects for China, EU, FDA, UK, Japan, Australia and WHO inspection
  • 320 +
    Validation execution and guidance projects
  • 2400 +
    Globally RA registration projects
  • 1370 +
    Globally clients and pharmaceutical partners
  • 30 +
    Experts from China, US and EU
Professional Services, Standardized SOPs

Providing full-life cycle solutions for MAH project

If you have business needs
Contact Us