Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity in Hong Kong

The registration of pharmaceutical products containing new chemical or biological entities (NCEs/NBEs) in Hong Kong follows a rigorous regulatory framework to ensure public health and safety. This guide provides comprehensive information about the registration process and requirements.

Definition of New Chemical or Biological Entity

A new chemical or biological entity is defined as:

• A new active pharmaceutical ingredient (API) that has not been previously approved in Hong Kong
• A substance that has not been previously registered as a pharmaceutical product
• A biological product with a new molecular structure or mechanism of action

Registration Requirements

Documentation Requirements

1. Product Information

• Complete product description
• Detailed composition
• Manufacturing process
• Quality control procedures
• Stability data
• Shelf life information

2. Pre-clinical Data

• Pharmacological studies
• Toxicological studies
• Safety pharmacology
• Pharmacokinetic data

3. Clinical Data

• Phase I, II, and III clinical trial results
• Safety and efficacy data
• Risk-benefit analysis
• Post-marketing surveillance plan

4. Quality Documentation

• Manufacturing license
• GMP compliance certificate
• Quality control specifications
• Validation protocols
• Batch release procedures

Application Process

1. Pre-submission Meeting

   • Optional meeting with the Pharmacy and Poisons Board
   • Discussion of application strategy
   • Clarification of requirements

2. Application Submission

   • Complete application form
   • All required documentation
   • Application fee payment

3. Review Process

   • Initial screening
   • Technical review
   • Expert consultation
   • Decision making

4. Post-approval Requirements

   • Regular safety updates
   • Periodic benefit-risk evaluation
   • Post-marketing surveillance
   • Adverse event reporting

Special Considerations

Fast Track Registration

Products may qualify for fast track registration if they:

• Address unmet medical needs
• Show significant therapeutic advantages
• Treat serious or life-threatening conditions

Conditional Registration

In certain cases, conditional registration may be granted with:

• Specific post-marketing commitments
• Additional safety monitoring requirements
• Limited initial approval period

Regulatory Compliance

Ongoing Obligations

• Regular safety updates
• Quality control monitoring
• Adverse event reporting
• Labeling updates
• Manufacturing changes notification

Post-marketing Surveillance

• Pharmacovigilance system
• Risk management plan
• Periodic safety update reports
• Signal detection and management

Best Practices

For Applicants

1. Early Planning

   • Start preparation early
   • Identify all requirements
   • Plan for potential delays

2. Documentation

   • Maintain complete records
   • Ensure data integrity
   • Follow formatting guidelines

3. Communication

   • Regular updates to authorities
   • Prompt response to queries
   • Clear documentation

For Healthcare Professionals

1. Prescribing Considerations

   • Review safety data
   • Monitor patient response
   • Report adverse events

2. Patient Education

   • Explain benefits and risks
   • Provide usage instructions
   • Monitor compliance

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