The "1+" Mechanism: Accelerating New Drug Registration in Hong Kong

The "1+" mechanism represents a significant advancement in Hong Kong's pharmaceutical regulatory framework, designed to expedite the registration and approval of new drugs, including advanced therapy products and vaccines.

What is the "1+" Mechanism?

The "1+" mechanism is an innovative drug registration pathway that:

• Allows new drugs to be registered in Hong Kong with approval from at least one recognized reference agency
• Streamlines the registration process for new chemical entities
• Includes advanced therapy products and vaccines
• Aims to improve patient access to innovative treatments

Implementation and Progress

Timeline

• Launched in November 2023
• Expanded to cover all new chemical entities in November 2024
• Continuous process optimization and guideline development

Current Achievements

• Over 80 pharmaceutical companies engaged
• More than 260 drug entities under consideration
• Five drugs already approved, including:
  • CAR-T therapy for cancer patients
  • Integration into Hospital Authority Drug Formulary

Benefits and Impact

For Patients

1. Improved Access

   • Faster availability of new treatments
   • Access to innovative therapies
   • Enhanced healthcare options

2. Cost Benefits

   • Increased competition
   • Potential cost reduction
   • Better affordability

For Pharmaceutical Industry

1. Market Opportunities

   • Streamlined registration process
   • Access to Hong Kong market
   • Gateway to Greater Bay Area

2. Development Support

   • Encouragement for R&D investment
   • Simplified approval pathway
   • Enhanced market potential

For Healthcare System

1. Quality Enhancement

   • Access to advanced therapies
   • Improved treatment options
   • Enhanced healthcare standards

2. Regional Integration

   • Greater Bay Area connectivity
   • Cross-border healthcare development
   • Regional healthcare advancement

Greater Bay Area Integration

Special Drug and Medical Devices Connect Measure

• Enables use of Hong Kong-registered drugs in GBA
• Covers 68 million population
• Provides "green channel" for approved products
• Facilitates cross-border healthcare delivery

Benefits for Pharmaceutical Companies

1. Market Access

   • Single registration for multiple markets
   • Expanded patient population
   • Streamlined approval process

2. Development Opportunities

   • R&D promotion in GBA
   • Enhanced market potential
   • Regional collaboration

Future Developments

Expected Growth

• Increasing industry interest
• More drug applications
• Expanded product portfolio
• Enhanced healthcare options

Ongoing Improvements

• Process optimization
• Guideline development
• Industry adaptation
• System enhancement

Contact Information

For further information or assistance:

• Pharmacy and Poisons Board

  • Website: www.ppbhk.org.hk

• Drug Office, Department of Health

  • Website: www.drugoffice.gov.hk