The fast-growing global demand for livestock-derived products and pet health care has driven the animal healthcare industry to develop safe, efficacious, and high-quality veterinary medicinal products. The commercialization of most veterinary medicinal products, similar to human medicine, requires the marketing authorization from regulatory authorities. However, the complexities of regulatory environment and inconsistent regulatory requirement at different markets have still been a hurdle for multinational companies to rapidly bring new products to the market, especially to China. The objective of this study is to provide a systemic analysis on China’s regulatory landscape as well as to help animal healthcare firms develop a well-structured and robust in-country regulatory affairs strategy in China.We started from examining existing regulatory challenges and conducting gap analysis on currently proposed solutions to regulators and industry. The roadmap comprising key driving forces and elements to the regulatory approval in China as well as potential roadblocks were analyzed and constructed. The proposed “Schematic of Regulatory Affairs Process” offers a practical approach for multinational animal healthcare firms to develop the most rewarding regulatory affairs strategy in China via capturing required forces driving to the regulatory approval of veterinary medicinal product.

1. Introduction ......1
2. Review.....4
2.1. Overview of Animal Healthcare (AH) Industry ....4
2.2. Regulatory Landscape for Animal Healthcare Product ....8
2.2.1. Regulatory Body and Regulatory Framework....9
2.2.2. Key Animal Healthcare Stakeholder ......14
2.2.3. Registration Process and Timeline ......17
2.2.4. Regulatory Requirement and Assessment Approach ....22
2.3. Regulatory Challenge and Impact on Animal Healthcare Products .....26
2.3.1. at a Global Level .......26
2.3.2. at a Regional Level .......29
2.3.3. at a Country Level .......34
2.4. China Focus ......39
3. Gap Analysis ........42
3.1. on Proposed Solutions to Regulatory Challenges for Regulators ..........43
3.2. on Proposed Solutions to Regulatory Challenges for AH Industry ......46
4. Proposed Solution ........49
iv
4.1. Roadmap to Regulatory Approval in China .....50
4.2. Roadblocks to Regulatory Approval in China .....52
4.3. “Schematic of Regulatory Affairs Process” to Regulatory Approval........57
4.3.1. Regulatory Landscape Analysis .......57
4.3.2. Creating Forces to Regulatory Approval .....62
4.3.3. Capturing Forces to Regulatory Approval ......64
4.3.4. Sustaining Forces to Regulatory Approval ......68
5. Conclusion .....69
6. Reference ......73

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