FDA与印度药监机构合作进展
出自识林
FDA与印度药监机构合作进展
笔记 2015-03-19 FDA Voice Howard Sklamberg 和 Michael Taylor 大约80%的原料药、40%的成品药、80%的海产品、50%的新鲜水果和20%的的新鲜蔬菜来自美国本土以外，这可能会令许多人感到惊讶，但这是事实。 每年，FDA需要评估数百万种植、收获、加工、制造并从美国以外运输来的产品。这样全球化的生产、消费和贸易是如何改变监管环境的最令人印象深刻的例子之一就是印度。 印度正迅速成为全球市场中一个重要的参与者，代表了FDA监管产品的一个重要来源。印度由于有着多种多样的人口、高技能的劳动力和良好的经济环境，已经成为一个对公司经营越来越有吸引力的地方。 从而，印度监管机构已经成为FDA的重要战略合作伙伴。现在，我们与他们就从分享临床试验信息，到协同应对可能损害美国消费者的产品安全问题的所有事务定期交流。 Hamburg局长于去年访问印度时，她评论指出“随着进入美国的供应商数量不断增长，商业的快速全球化给确保消费者安全带来了重大挑战。”在她访问期间，她签署了一份我们两国之间里程碑式的意向书，寻求“共同努力改善两国监管机构之间的沟通渠道，并努力确保印度出口的产品是安全的、高品质的。” 我们渴望继续Hamburg局长已经开启的工作。其中她谈到改善交流渠道是我们工作访问印度的目的。出行前，我们与我们的团队讨论对此次行程的期望是什么。我们的首要目标是倾听和学习。我们希望了解，关于药品和食品安全，印度政府正在面临着什么样的挑战。我们希望听到在印度经营的美国公司和印度生产商的声音。我们希望与我们的印度同行，讨论一些影响到我们之间关系的美国监管体系的重要变化。 最近由于少数制药企业质量方面的过失，我们两国监管机构之间的关系受到挑战，这已不是什么秘密。虽然我们的首要监管职责是保护美国患者和消费者，我们也非常愿意与印度监管机构和其他利益攸关者合作，确保实现安全和质量的最高标准。我们认为这将惠及两国。 我们已经收获了一些这方面合作的成果。美印两国之间合作的一个重要案例发生在2012年，当时沙门氏菌的爆发追溯到一个印度制造商。FDA的检查证实牵涉到沙门氏菌爆发的金枪鱼产品来自一个嫌疑设施，印度政府撤销了该制造商的执照。 在另一起案例中，FDA印度办公室与其他美国政府机构合作，通告企业界和印度监管机构关于从印度进口的印度香米的进口禁令问题。FDA办公室共享了农药残留检测的实验室程序。 最近，2014年11月，作为FDA努力加强进口药品的质量、安全和完整性的持续工作，FDA印度办公室，与药品审评与研究中心（CDER）合规办公室和监管事务办公室合作，在印度举办了四次研讨会。研讨会与欧洲药典（EDQM）和药品信息协会（DIA）合作举办，同时还包括印度药品生产商协会、美国注射药物协会（PDA）以及印度制药生产商组织。来自制药企业的超过560名参会人参加了四次为期两天的研讨会。 我们相信我们此次印度之行将产生更多的此类富有成效的合作实例，推动两个世界最大民主国家之间的监管关系进入下一阶段，从意向到共同合作，有能力共同解决两国共同面临的复杂的全球化问题。 编译：识林-椒 2015-03-19 In India, With Our Sleeves Rolled Up These facts surprise many people, but roughly 80 percent of active pharmaceutical ingredients, 40 percent of finished drugs, 80 percent of seafood, 50 percent of fresh fruit and 20 percent of fresh vegetables come from outside of the U.S. Each year, the FDA has to assess millions of products grown, harvested, processed, manufactured and shipped from outside of the U.S. And one of the most impressive examples of how this globalization of production, consumption and trade has altered the regulatory landscape is India. India is quickly becoming a significant player in the global marketplace, representing an important source of FDA‐regulated products. With a diverse population, highly skilled work force, and favorable economic conditions, India has become an increasingly attractive location for companies to operate. And with that, Indian regulators have become important strategic partners for FDA. Today, we regularly engage with them on everything from sharing information on clinical trials to collaboratively addressing product safety issues that may harm American consumers. When Commissioner Hamburg visited the country last year, she remarked that the “rapid globalization of commerce has posed significant challenges to ensuring consumer safety as the number of suppliers entering the U.S. has increased.” On her visit she signed a milestone Statement of Intent between our two countries seeking to “collectively work together to improve the lines of communication between our agencies and work diligently to ensure that the products being exported from India are safe and of high quality.” We are eager to continue the work she started. And improving the lines of communication of which she spoke is the purpose of our working visit to India. Before the trip we discussed with our teams what we expect from our journey. Our top goal is to listen and learn. We want to understand what challenges the Indian government is facing with regard to drug and food safety. We want to hear from both American companies operating in India, as well as Indian manufacturers. And we want to discuss with our Indian counterparts a number of significant changes in the American regulatory system that affect our relationship. It is no secret that relationship has been challenged in the recent past by lapses of quality at a handful of pharmaceutical firms. And while our first regulatory responsibility is to protect the American patient and consumer, we are also very willing to collaborate with Indian regulators and other stakeholders to ensure the achievement of highest standards of safety and quality, something we feel only benefits both nations. We have harvested some of the fruits of this cooperation already. A significant example of collaboration between the U.S. and India occurred in 2012, when a Salmonella outbreak was traced to a manufacturer in India. An FDA inspection confirmed that the tuna product implicated in the outbreak came from the suspect facility, and the Indian government revoked the manufacturer’s license. In yet another case, FDA’s India office worked with other United States government agencies to inform industry and Indian regulators about issues associated with an import alert for Basmati rice from India. The FDA office shared laboratory procedures for testing of pesticides. More recently, in November of 2014, as a continuation of FDA’s efforts to strengthen the quality, safety and integrity of imported drugs, the FDA India Office, in collaboration with our Center for Drug Evaluation and Research’s Office of Compliance and the Office of Regulatory Affairs, held four workshops in India. The workshops were held in partnership with European Directorate for the Quality of Medicines and Drug Information Association and involved the Indian Drug Manufacturers Association, Parenteral Drug Association and Organization of Pharmaceutical Producers of India. Over 560 participants from the pharmaceutical industry attended the four two-day workshops. We are confident our trip will yield more examples of such fruitful collaboration, moving the regulatory relationship between two of the world’s largest democracies to the next stage, from the intention to work together, to the ability to work together to solve the complex globalization issues facing both nations. Howard Sklamberg is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy |