This seminar will provide an invaluable overview of how to gain and maintain a successful pharmaceutical marketing authorisation in the People’s Republic of China (PRC), including Hong Kong, Macau and Taiwan. The two-day course will cover:
- All important aspects of gaining and maintaining a successful marketing authorisation in the region
- Recent regulatory reforms
- Drug regulatory systems
- An overview of import and local manufacture registration
- Clinical product development including CMC regulatory requirements
- An interpretation of practical aspects
- The opportunity to exchange experiences with other delegates
Benefits of attending:
- Gain an overview of the regulatory procedures in the region
- Understand and assess the impact of recent regulatory reforms
- Discuss clinical product development and Chinese-specific approaches
- Understand requirements for import and local manufacturing registration
- Discuss product registration strategies
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Course Content
Day 1
General introduction to the PRC and the pharmaceutical market
- Commercial and cultural background
P.R. China - Drug Regulatory Systems
- Regulatory authorities
- Recent regulatory changes
- Regulations and guidelines
- Drug classification systems
- Import and local manufacturing registration
- Data requirements
- Registration requirements
- Labelling requirements
P.R. China - Clinical Product Development
- Regulatory aspects of clinical development
- Recent regulatory changes
- Documentation needs including CMC
- Regulatory requirements including GCP aspects
- Chinese-specific approaches
- Multinational clinical trials
Hong Kong SAR
- Background overview
- Regulatory authorities
- Regulatory requirements and procedures
- Specific market aspects
Macau SAR
- Brief overview of regulatory aspects
Day 2
P.R. China - Regulatory Strategies
P.R. China - Health Authority Interactions
P.R. China - Maintenance
Taiwan (Republic of China)
- Cultural background
- Regulatory authorities
- Regulations and guidelines
- Drug classification systems
- Data requirements
- Country-specific matters
P.R China - Recent Developments
