The official GAP certification cancel medicinal supervision at the source for new Sohu news-mycoolboy

The official cancellation of GAP certification, the source of traditional Chinese medicine supervision waiting for the new deal – Sohu news reading, many analysts told the twenty-first Century economic report reporter, the existing GAP certification on the standardization of Chinese herbal medicine is very limited impact. In the planting and production of Chinese medicinal materials, there are still many phenomena such as multiple management, decentralized management, etc., and the connection between the market and enterprises is still relatively loose. Some Chinese herbal medicine planting bases have not formed the industrial management mode of benefit sharing and risk sharing. The reporter Xiao Meili Guangzhou reported suddenly landed a notice, officially canceled the trial of 14 years of Chinese herbal medicine production quality management specification (GAP) certification. In February 16th, CFDA (national food and Drug Administration) announced by the official website, according to the State Council issued "on the cancellation of the 13 departments of the State Council administrative licensing decision" (national hair [2016] 10), the provisions of the cancellation of the Chinese herbal medicine GAP certification. Many analysts to the twenty-first Century economic report reporter said that the existing GAP certification on the standardization of Chinese herbal medicine is very limited. In the planting and production of Chinese medicinal materials, there are still many phenomena such as multiple management, decentralized management, etc., and the connection between the market and enterprises is still relatively loose. Some Chinese herbal medicine planting bases have not formed the industrial management mode of benefit sharing and risk sharing. At the same time, the abolition of GAP certification also means that the source of traditional Chinese medicine supervision more stringent. Shi Lichen, director of pharmaceutical consultation in Beijing, said: "last year, a large number of GMP certificates were canceled, and Ginkgo biloba and calf blood events were investigated, which proved that the supervision of traditional Chinese medicine industry will become more stringent, and the control of all aspects of Chinese herbal medicine will be more direct.". Only when the supervision becomes stricter and the market is standardized, can the quality of Chinese medicine be improved." Since the end of the 14 year trial, the upsurge in the cultivation of Chinese herbal medicines throughout the country has not subsided. However, due to the cultivation of non-standard, backward technical level, extensive management and other practical reasons, the quality of Chinese herbal medicines are often good and bad, heavy metal content exceeded the standard, pesticide residues and other problems have occurred. Under this background, in March 18, 2002, the State Drug Administration Executive Council passed the "Chinese herbal medicine production quality management standards (Trial)", the code came into force on June 1, 2002. Relevant information shows that GAP certification covers the planting resources selection, planting site selection until the Chinese herbal medicine sowing, field management, procurement, origin processing, packaging, transportation and warehousing process, to encourage standardization and scientific planting. The starting point of "GAP certification" is to standardize the front end of the whole Chinese medicine. But the rules of many planting bases are not very consistent with the actual situation." Www pharmaceutical industry analyst Zhao Zhen told reporters that the planting base is in accordance with the regional and domestic varieties to the division, each region has its own characteristics, closely each place special herbs with local soil, air and other related. If the production according to the GAP standard, it is very difficult to complete the water, light, soil, air and other aspects of the standards. In addition, the cost of acquiring the GAP certificate is not the same as that of the related enterprises.

官方取消GAP认证 中药材源头监管等待新政-搜狐新闻  导读   多名分析人士向21世纪经济报道记者表示,现有的GAP认证对中药材规范化影响十分有限。在中药材种植与生产环节,依旧存在多头管理、分散经营等现象,与市场和企业之间的联结仍旧较为松散。部分中药材种植基地还未形成利益共享、风险共担的产业化经营模式。   本报记者 肖玫丽 广州报道   突然落地的一纸通知,正式取消了试行14年的中药材生产质量管理规范(GAP)认证。   2月16日,CFDA(国家食药监总局)通过官网宣布,依据国务院印发《关于取消13项国务院部门行政许可事项的决定》(国发〔2016〕10号),规定取消对中药材GAP的认证。   多名分析人士向21世纪经济报道记者表示,现有的GAP认证对中药材规范化影响十分有限。在中药材种植与生产环节,依旧存在多头管理、分散经营等现象,与市场和企业之间的联结仍旧较为松散。部分中药材种植基地还未形成利益共享、风险共担的产业化经营模式。   与此同时,取消GAP认证也意味着中药材的源头监管趋严。北京鼎臣医药咨询负责人史立臣认为:“去年取消了大量的GMP证书还查处了银杏叶、小牛血事件,这都证明中药行业的监管还会趋严,对中药材各个环节的把控也会更加直接。只有监管趋严了、市场规范了,中药质量才能提升。”   试行14年终取消   长期以来,全国各地的中药材种植热潮不曾消退。然而,由于种植不规范、技术水平落后、管理粗放等现实原因,中药材品质往往良莠不齐,重金属含量超标、农药残留等一系列问题也时有发生。   在此背景下,2002年3月18日,国家药品监督管理局局务会审议通过了《中药材生产质量管理规范(试行)》,该规范于2002年6月1日起施行。相关资料显示,GAP认证是涵盖种植资源选择、种植地选择一直到中药材的播种、田间管理、采购、产地初加工、包装运输以及入库整个过程,鼓励规范化、科学化种植。   “GAP认证的出发点就是要把整个中药的前端规范起来。但是很多种植基地的规则跟实际情况不太符合。”卓创资讯医药行业分析师赵镇告诉记者,中药材种植基地是按照区域和品种来划分的,国内各个区域都有自身的特色,每个地方的特色药材跟当地的土壤、空气等都紧密关联。如果完全按照GAP标准来生产,要做到水、光照、土壤、空气等环节完全符合标准很有难度。   另外,相关企业要获得GAP证书所需的成本也不小。作为云南丽江种植和销售三七规模较大的企业,丽江康源生物副总经理王春云向记者坦言,获取GAP证书所需的资金虽然不多,但是要按照GAP的要求来设厂,因而认证周期比较长,维护成本也不低,“我们办了两年多才拿到证。”   “不仅如此,种植的风险也很大,受天气、自然灾害这些人力不可抗拒的因素影响。现在大多数企业都是部分自己种植、部门交给有条件的农户种植。因为能力范围是有限的。”王春云表示。   根据中药材产业研究院发布的《2014-2018年中国中药材GAP基地发展模式与投资战略规划分析报告》数据显示,中药材GAP基地认证从2004年至2014年6月,共有152个基地通过了中药材GAP认证。2015年,CFDA又通过了24个中药材GAP认证。在资本市场上,包括同仁堂(600085.SH)、云南白药(000538.SZ)、康美药业(600518.SH)、以岭药业(002603.SZ)在内的大多数A股中药上市公司都建有中药材GAP生产基地。   “GAP在行业内比较普及,但是消费者并不知情,招标和消费的过程中GAP的优势也没体现出来。国内中药材市场中90%的中药材还是野外的和散户生产的,所以GAP生产的中药材在市场中的竞争压力很大。”史立臣进一步说道。   源头监管仍待破局   GAP认证取消之后,新的监管政策并没有随之出台。不过,业界一致认为,中药材各个环节的监管不会缺位,整个中药行业的监管也会日益趋严。   就在2月14日,国务院总理李克强主持召开国务院常务会议,确定进一步促进中医药发展措施,提出完善中医药标准体系,强化中药材资源保护利用和规范种养。   对此,史立臣告诉记者:“农残超标、重金属、有效成分的含量这几个环节是必需要监管的,中药材的质量问题也大多是出在这三个环节上。”赵镇也认为,中药材的源头不能出现监管真空。“未来各个地区的监管不一定都很严格,这得跟各个地区的实际结合,但是肯定会更加具有适用性。对于原先已经投入认证的企业,应该要给予一定的优惠政策、补助政策。”   关于后续的管理办法,坊间流传较多的版本有三个:第一是未来会改成备案制;第二是GAP认证像GMP认证(药品生产质量管理规范)一样下放到省局;第三则是由外部第三方承担GAP认证的相关工作。   在史立臣看来,坊间流传的这三个方案并不可行。如若实施备案制,所有企业和农户都可以种植,这样设立GAP认证的效果就不明显。如若下放到省局,则意味着可以根据当地的需要去做调整,但是现有的中药材质量问题还是会存在。而若由第三方进行认证,就可能会导致机构出于利益的需求监管不到位,或者直接导致证书的高价销售。   “实际上监管不应该在种植环节下手,真正的优质中药材大部分是野生的,难以用固定的标准规范起来。应该是从市场层面下手,中药材的市场准入要有标准,市场采购或者药企销售的必须有市场准入证书,通过倒逼的方式实现中药材种植生产环节的质量把控。”史立臣指出。相关的主题文章: