Application Instructions The submission must not exceed 14 pages and consists of six sections: Rationale for Product Selection (max. 3 pages) Give a brief overview of why the product candidate has been selected, e.g. impact on human health, technical innovation, etc. Aspects of the product which the applicant considers to be unique and innovative should be clearly stated. History of Product Development (max. 3 pages) Outline the historical context of the development of the product. Give a brief description of how it was discovered and the overall rationale for its development, including marketing rationale, previous research/company product involvement. Emphasize the China’s contribution (if applicable) to the development of the product. Safety and Efficacy (max. 3 pages) Describe the relative safety and efficacy of the product and summarize the key studies on which safety and efficacy are based. Emphasize the Chinese contribution (if applicable). Describe the effectiveness of the product and its place in therapy. Additional Product Benefits (max. 3 pages) Outline the other benefits of the product, e.g. cost benefit analysis, ease of dosage, patient compliance. Summary (max. 1 page) Entry form duly completed and signed Appendix: Maximized Five (5) published original articles including no more than one review article.
Application Instructions The submission must not exceed 14 pages and consists of six sections: Rationale for Product Selection (max. 3 pages) Give a brief overview of why the product candidate has been selected, e.g. impact on human health, technical innovation, etc. Aspects of the product which the applicant considers to be unique and innovative should be clearly stated. History of Product Development (max. 3 pages) Outline the historical context of the development of the product. Give a brief description of how it was discovered and the overall rationale for its development, including marketing rationale, previous research/company product involvement. Emphasize the China’s contribution (if applicable) to the development of the product. Safety and Efficacy (max. 3 pages) Describe the relative safety and efficacy of the product and summarize the key studies on which safety and efficacy are based. Emphasize the Chinese contribution (if applicable). Describe the effectiveness of the product and its place in therapy. Additional Product Benefits (max. 3 pages) Outline the other benefits of the product, e.g. cost benefit analysis, ease of dosage, patient compliance. Summary (max. 1 page) Entry form duly completed and signed Appendix: Maximized Five (5) published original articles including no more than one review article.
PrixGalienChina2019-Product.docx