国务院新闻办公室新闻发布会材料

新闻稿

（2016年2月29日）

国家食品药品监督管理总局

食品药品监管的宗旨是维护公众健康、促进公众健康。新一届党中央、国务院作出改革食品药品监管体制的决定，整合分散在工商、质监、食药等部门的食品和药品监管职能，成立食品药品监管总局，建立从中央到地方直至基层的食品药品监管体系，对生产、流通、消费环节的食品安全和药品的安全性、有效性实施集中统一监管，维护广大人民群众饮食用药安全。

在过去一年，食品药品监管部门认真落实习近平总书记“最严谨的标准、最严格的监管、最严厉的处罚、最严肃的问责”要求，认真贯彻落实党中央、国务院的工作要求和改革部署，以信息公开为突破口，增加食品药品检查、抽样检验的范围和频率，严厉查处食品药品领域违法犯罪行为，第一时间公开抽检结果、检查情况和案件查处信息，维护消费者权益，震慑违法犯罪分子，约束执法者行为，发挥社会舆论监督作用，促进社会诚信体系建设。积极推进药品审评审批制度改革。提高药品审评审批标准，按照与原研药品质量和疗效一致的原则，对新申请上市药品和仿制药进行技术审评，对已经上市的仿制药开展一致性评价。简政放权，提高效率，推进药品上市许可持有人的试点，促进制药工业由生产大国向质量强国转变。

当前我国正处在食品药品安全矛盾高发期，保障食品药品安全，任重道远。在新的一年里，我们将按照党中央、国务院要求，继续加强市、县两级食品抽样检验和生产经营企业、餐饮企业的日常检查，整治农兽药残留超标和添加剂滥用等违法行为；切实加强标准的制定、法规的完善、药品研发相关技术指导原则起草等基础性工作；继续加大对各类食品药品安全违法犯罪的打击力度；继续做好检查检验和案件查处信息公开工作，提高食品药品监管透明度，增强公众对中国制造食品药品的信心；加快完善统一权威的食品药品监管体制和制度，努力打造一支技术过硬、作风优良、勤政廉洁的职业化监管队伍。

强大的监管才能造就强大的产业。食品药品企业既是食药部门的监管对象也是服务对象。各级食药监管部门要寓监管于服务之中，以有效的监管制度创新服务于产业的发展创新，推动食品药品产业的供给侧结构性改革，夯实食品药品安全的产业基础。食品药品是民生问题，也是社会问题，希望社会各界参与食品药品监管工作，推动食品安全社会共治，同各级食药监管部门一起努力，共同维护好广大人民群众“舌尖上的安全”。

Material for the press conference of the State Council Information Office

News Release

(29February, 2016)

China Food and Drug Administration

The purpose of food and drug administration is to protect and promote public health. The new session of the central committee of CPC and the State Council had decided to reform the country’s food and drug regulation system and to establish China Food and Drug Administration(CFDA), by integrating the food and drug regulatory functions scattered in the former departments of industry and commerce regulation, quality and quarantine administration and food and drug regulation, and by setting up the food and drug agencies from central to local and grassroots level to employ unified regulation for the safety and efficacy of drugs and for the safety of food throughout the stages on manufacture, circulation and consumption, in order to protect food and drug safety for the public.

In the year past, CFDA had made all efforts in implementing General Secretary Xi Jinping’s requirements of “the most rigorous standards, the most strict supervision, the most severe punishment and the most serious accountability”, and CPC central committee’s and the State Council’s requirements and the reform strategies. We had made breakthroughs by information publicity, increased the scope and frequency of inspection, sampling and testing on food and drug products, seriously punished illegal activities in food and drug areas, and publicized the results of sampling, inspections and case punishment on the first time to the public in order to protect consumers’ interests, to stop criminals and to constraint the regulators’behaviors. Besides, we encourage the social media to play a full role in supervision and, we endeavor to promote the build-up of social credibility system. We had raised the standards for drug evaluation and approval. We had carried out technical evaluation on new generic drug applications under the principle of consistency with the original drugs on quality and efficacy. And we had also carried out consistency evaluation on generic drugs that had already been marketed. We had streamlined administration and delegated power to improve efficiency. We are promoting pilot projects on Market Authorization Holder system to help our pharmaceutical industry transfer from a giant manufacturer to a great, best quality provider.

Recently, we are experiencing a period with high probability of food and drug problems. It is an arduous task to protect food and drug safety and the road is long. In this year, in answering the requirements from the CPC central committee and the State Council, we will continue to strengthen the sampling and testing on food at municipality and county level, and to strengthen daily inspections on food manufacturers, distributors as well as catering enterprises. We will punish all illegal activities such as providing products with excessive residues of agricultural and veterinary drug as well as the abuse of additives. We will further enhance the fundamental work of improving standards, perfecting regulations and drafting guidelines and technical requirements for drug research and development. We will enhance our efforts to strengthen the fight against all kinds of illegal activities on food and drug safety. We will further improve information publicity regarding inspection and testing as well as case investigation, to improve the transparency of regulation, to increase the people’s confidence towards food and drug made in China. We will work hard to accelerate the improvement of independent and authoritative regulation institution and mechanism, to build up a professional team who is well skilled, fine styled, diligent and clean.

A strong regulation helps bring up a stronger industry. Food and drug enterprises are stakeholders of regulation in terms of complying regulation and receiving services. Regulatory agencies at all levels should combine supervision with service, to support the development and innovation of industry with efficient regulatory innovation, to facilitate the reform of supply side on food and drug industry, and to establish a sound base of the industry for food and drug safety. Food and drug safety concerns people’s livelihood and social development. We wish that all parties of our society with people from all circles participate in the supervision on food and drug, to promote social governance on food safety, and together with regulatory agencies at all levels to make joint efforts to protect “the safety on the tip of our people’s tongue”.