生物医药工业是健康中国建设的重要基础。全国人大代表、全国工商联执委、重庆智飞生物股份有限公司副董事长蒋凌峰表示，我国在基础研究力量和关键核心技术源头供给、关键核心技术国产替代的环境培育等方面存在不足和短板。蒋凌峰建议，推动生物医药产业物料国产化替代，保障生物医药产业供应链安全。
“从国家层面，加强国产化替代的政策支持；从监管层面，制定优先审评制度、优化工作流程；从技术层面，监管部门对国产化替代研究提供技术支持。”蒋凌峰建议，促进工信、药监等多部门合作。药监部门以提前介入、持续跟踪、研审联动、增加补充资料途径等方式，以及通过滚动沟通交流机制，促进国产替代快速落地。对实现国产化替代而进行的变更研究，制定灵活的评价标准及体系，在科学评估和保证药品质量可控的前提下，尽量减少不必要的变更研究要求，确保企业高效快速地实现国产化替代。
蒋凌峰建议，推动生物医药企业利用国产化替代进行产业升级。系统实施国产医药原料、包材、耗材、中间体质量提升工程，制定符合现状的生物医药行业标准和国家标准，鼓励支持生物医药企业利用国产化替代进行生产工艺优化和产品质量提升，对生物医药企业国产化替代的研发提供支持。
此外，蒋凌峰建议发挥需求侧引领作用，出台优先采购扶持政策。同时，强化基础研究，加大财政和金融扶持。
“国家医保局和地方医保部门出台相关政策，对实施国产化替代较为领先的企业和产品在医保准入、定价、采购和报销比例等方面给予倾斜，支持生物医药企业积极选择使用国产设备和原辅包耗材，对于国产化率达到一定比例的产品和生产线优先准入。”蒋凌峰建议。
翻译：
Jiang Lingfeng, vice chairman of Chongqing Zhifei Biological Co., LTD. : Promote the substitution of bio-pharmaceutical industry materials
The biomedical industry is an important foundation for building a healthy China. Jiang Lingfeng, deputy to the National People’s Congress, executive committee member of the All-China Federation of Industry and Commerce, and vice chairman of Chongqing Zhifei Biological Co., LTD., said that China has shortcomings and shortcomings in basic research strength and source supply of key core technologies, and environmental cultivation of domestic replacement of key core technologies. Jiang Lingfeng suggested that the localization of materials in the biomedical industry should be promoted to ensure the safety of the supply chain of the biomedical industry.
“From the national level, strengthen the policy support for localization substitution; From the supervision level, formulate the priority review system and optimize the working process; From the technical level, the regulatory authorities provide technical support for the localization of alternative research.” Jiang Lingfeng suggested promoting multi-departmental cooperation such as industry and information technology and drug administration. The drug regulatory department promotes the rapid landing of domestic alternatives by means of advance intervention, continuous tracking, research and review linkage, increasing supplementary information channels, and rolling communication and exchange mechanisms. On the change research for the realization of domestic substitution, flexible evaluation standards and systems should be formulated to minimize unnecessary change research requirements under the premise of scientific evaluation and ensuring drug quality control, so as to ensure that enterprises can realize domestic substitution efficiently and quickly.
Jiang Lingfeng suggested that biopharmacetical enterprises should be promoted to use localization to replace industrial upgrading. Systematic implementation of domestic pharmaceutical raw materials, packaging materials, consumables, intermediates quality improvement projects, the development of biomedical industry standards and national standards in line with the status quo, encourage and support biomedical enterprises to use domestic substitution for production process optimization and product quality improvement, and provide support for the research and development of domestic substitution of biomedical enterprises.
In addition, Jiang Lingfeng proposed to play a leading role on the demand side and introduce preferential procurement support policies. At the same time, we will strengthen basic research and increase fiscal and financial support.
“The National Medical Insurance Bureau and local medical insurance departments have issued relevant policies to tilt the implementation of localization to replace the more leading enterprises and products in terms of medical insurance access, pricing, procurement and reimbursement ratio, support biomedical enterprises to actively choose to use domestic equipment and raw and auxiliary package consumables, and give priority to products and production lines with a certain proportion of localization.” Jiang Lingfeng suggested.
