Strategies for regulation of innovative non-vaccine biologics for disease prevention in China: a SWOT analysis

Abstract

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.

Keywords

• preventive biological products
• supervision
• swot analysis