The Drug Marketing Authorization Holder System (MAH System) is a major reform and transformation of my country’s drug registration system. With the deepening of the implementation of the drug marketing authorization holder system, the MAH system has realized "unrestricted" approval, separated production license and drug registration approval, optimized the resource allocation of the pharmaceutical industry, and set off the transformation of sales-oriented pharmaceutical companies into B-certificate companies. upsurge. According to incomplete statistics from Yaorong Cloud, 1,000+ B-certificate companies have emerged across the country, showing a thriving trend.

However, since the development of the MAH system, it is facing a more complex industry situation. In the context of tightened supervision, how to strengthen the quality management capabilities, risk prevention and control capabilities, and liability compensation capabilities of MAH holders? Practical questions such as how to complete commissioned production and change production addresses still need to be answered. Based on this, the Pharmaceutical Financial Circle organized the MAH B Certificate Enterprise Summit Forum, which will be held at the Suzhou International Expo Center on August 15-16, 2024. Drug regulatory experts and senior industry experts will be organized to interpret the MAH policy and focus on the B certificate application under the MAH system. Topics such as processes, on-site inspections, post-market changes, product project approval, and industrial policies are based on attracting B-certificate companies and solving practical problems of B-certificate companies. We answer questions and resolve doubts to help the implementation of MAH industrialization and promote the high-quality development of the pharmaceutical industry!

• #Getting Started—B Certificate Enterprise Regulations and Policies
• 1. Analysis of the origin of the MAH system and current trends in the B certificate industry
• 2. Interpretation of the latest regulatory policies for entrusted production by B certificate enterprises
• 3. Sharing practical experience of B certificate enterprises: How to apply for B certificate under current regulations
• 4. Establishment of B certificate enterprise quality system and full life cycle quality risk management
• 
  
• #products-B certificate enterprise product project approval
• 5. MAH B certificate enterprise product project ideas and cases
• 6. Pharmaceutical process technology management under the MAH system
• 7. Regulatory requirements and frequently asked questions about product technology transfer under the MAH system
• 8. Case analysis on focus and defect cases of on-site inspection of drug registration of MAH B certificate enterprises
• 
  
• #PRODUCTION—Entrusted production by B certificate enterprises
• 9. How do MAH B certificate companies select and audit entrusted production companies?
• 10.B certificate enterprise entrusted production collinear risk assessment and case sharing
• 11. Key points and defect analysis for B certificate enterprises to receive inspection
• 
  
• #Change—Change management of B-certificate enterprises
• 12. Interpretation of post-market change management policy for drugs
• 13. Legal requirements and practical guidelines for venue changes under the MAH system
• 14. Regulatory requirements and practical guidelines for holder changes under the MAH system