The market demand for veterinary drugs in China is substantial. However, companies must navigate the regulatory barrier due to China’s distinct and separate regulatory system.
This course aims to provide practical advice and guidance on successfully obtaining market approval for veterinary drugs in China. Participants will gain a comprehensive understanding of the necessary requirements.
Throughout the programme, expert speakers will elucidate relevant regulations, and registration procedures through presentations, while also addressing participant questions.
Benefits of attending
- Understand the relevant regulatory systems and frameworks
- Gain an insight into the specific data requirements
- Explore registration processes
- Learn the associated testing requirements
- Consider the costs for obtaining market approval
- Confirm about the applicability of overseas registration files and common issues encountered during import registration
Certifications:
- CPD: 1.5 hours for your records
- Certificate of completion
Agenda
China market access and regulatory requirements for veterinary drugs (VD)
Regulatory framework
- Competent authorities and responsibilities
- Definition of veterinary drugs (VD) in China
- Overview of regulations
Registration of imported feed/feed additives in China
- Registration types
- Data requirements
- Registration process
- Timeline
- Requirements for testing in China (e.g., confirmatory clinical trials)
- Validity period of registration
- Other key points (commissioned production, Good Manufacturing Practice (GMP), Chinese veterinary pharmacopoeia and other import legal standards, test guidance)
Speakers
Bi Jun,
knoellBi Jun is a pharmaceutical expert with more than 10 years of experience in health product development and registration in China. Currently in Knoell Shanghai, he is mainly responsible for regulatory support and the registration of pharmaceutical ingredients and packaging materials for human drugs (DMF), Biocides, feed/feed additives and veterinary drugs.
Who Should Attend
This event will be beneficial to companies interested in expanding into the Chinese markets, as well as to registration personnel responsible for market approval matters:
- New entrants to registration departments
- Veterinary medicinal product manufacturers
- Registration managers
- Research and development departments
- Academics with an interest in commercialising opportunities
