基于SWOT-CLPV模型山东省“医养结合”服务模式评价

全球生物医药技术日趋多元化，出现大量创新产品，如长效单克隆抗体等，在临床试验中展示了良好的预防效果。但依照我国目前的法律框架，此类发挥预防作用的生物制品因无法注册为预防用生物制品，进而无法发挥其预期的社会和经济效益。为了弥补法律漏洞可能带来的卫生公平性不足加剧问题，探究适宜我国非疫苗类创新型预防用生物制品监管策略，本文借鉴国际经验，结合我国实际，提出在我国类推适用《疫苗管理法》管理非疫苗类创新型预防用生物制品的监管策略，并对此种监管策略进行了优势、劣势、机会和威胁（strengths, weaknesses, opportunities, and threats, SWOT）分析；同时提出战略解决方案，为短期和长期的生物制品监管提供政策建议和参考。

Causes of severe pneumonia requiring hospital admission in children without HIV infection from Africa and Asia: the PERCH multi-country case-control study

With globally increasing diversification of biomedical technologies, a large number of innovative biologics, such as long - acting monoclonal antibodies, have shown good preventive effects in clinical trials. However, in accordance with current legal framework in China, such biologics cannot be registered as biological products for disease prevention and thus cannot be used to achieve intended social and economic benefits. In order to deal with the problem, the regulatory strategy suitable for non - vaccine innovative biologics for disease prevention needs to be developed. By drawing on international experience and combining the experience with Chinese reality, we proposed to apply the Vaccine Management Law analogically in the management of non - vaccine biologics for disease prevention based on a strengths, weaknesses, opportunities, and threats (SWOT) analysis and put forward some strategic solutions for providing reference to short - and long - term regulation of the biologics.