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【drug-news】FDA通过法案已增加在美国境外生产药
The U.S. Food and Drug Administration today announced the launch of a voluntary pilot program that would help promote the safety of drugs and active drug ingredients produced outside the United States.
The FDA plans to select 100 applicants to participate in the Secure Supply Chain pilot program. To qualify, applicants will need to meet the pilot program's criteria, including a requirement that they maintain control over the drug products from the time of manufacture through entry into the country.
The goal of the pilot is to allow FDA to determine the practicality of developing a secure supply chain program. Such a program would assist the agency in its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program and that may not be compliant. It will also expedite the entry of products meeting the pilot's criteria into the United States. The pilot was developed with input from U.S. Customs and Border Protection and other stakeholders. Information about the pilot appears in a Federal Register notice that went on display today.
"This initiative creates incentives for drug makers to develop and maintain secure supply chains," said Deborah Autor, Director of the Office of Compliance in FDA's Center for Drug Evaluation and Research. "This is one of several agency initiatives to enhance drug product safety."
Each applicant may designate up to five drugs for selection in the pilot program. To qualify, applicants will need to meet the pilot's criteria, including a requirement that they maintain control over the drugs from the time of manufacture through entry into the United States. A secure supply chain will help mitigate risks such as contamination and counterfeiting. Applications for participation in the pilot program will be processed in the order received.
"With the increase of drug products produced outside the United States, it is critical that the FDA concentrate its resources on companies that pose the highest risk of importing products that don't meet the FDA's standards and violate U.S. laws," said Michael Chappell, acting Associate Commissioner for Regulatory Affairs at FDA. "Consumers should know that only companies that maintain control over their products will be selected into this pilot program."
Companies wishing to participate in the two year pilot program must meet certain criteria, including:
For finished drug products, the applicant must hold an FDA-approved drug application or must be the foreign manufacturer identified in an FDA-approved application;
The active pharmaceutical ingredients imported must be used only to make FDA‑approved drugs;
Foreign drug manufacturers and U.S. establishments receiving drugs must be FDA-registered and comply with Good Manufacturing Practices; and
Applicants must show that their drug products use a secure supply chain.
The pilot program is planned to run for a period of two years.
http://www.fda.gov/bbs/topics/NEWS/2009/NEW01943.html 不知道pilot program怎么翻译，领航计划？导航计划？还是。。。反正不知道怎么翻译只知道大概说了啥 刚查了下pilot projet是试点项目，小规模试验计划，估计pilot program可以翻译成试点计划吧 美国FDA发起试点计划以增加美国境外药品及药物活性组分的安全性
美国食品药品监督管理局今日宣布，将发起一项志愿性质的“试点计划”以促进美国境外生产的药品及药物活性组分的安全性。
FDA计划挑选出100个申请者参与该“安全供应链”试点计划。要想获得加入该计划的资格，申请者需符合该试点计划的标准，包括有能力对从药物生产开始到该药物进入美国市场的整个流程的持续监控。
FDA希望通过实施该试点计划确定拓展安全供应链计划的实用性。该项目有助于FDA集中精力于不属于本计划内的境外生产的药品从而阻止不符合FDA要求的药品进口至美国。同时，该计划也将加速那些符合FDA标准的产品更快的进入美国市场。美国海关及其它利益相关者将参与到该试点计划中。
“该举措有利于激励药品生产商开发和维持安全的药品供应链”，FDA药品评价与研究中心执法办公室主任Deborah Autor如是说。
该计划允许每个申请者指定多达5个药物以供选择。为获得加入该计划资格，申请者必须满足该试点计划的要求，包括上述提及的有能力对从药物生产开始到该药物进入美国市场的整个流程的持续监控。安全的供应链有助于降低诸如药品污染及伪造的风险。
“随着（进口至）美国的境外药品生产的增多，FDA有必要集中精力于那些高风险的公司，这些公司进口的药品可能不能满足FDA标准并且违反美国法律。”FDA法律事务部代理副专员Michael Chappell说，“消费者应该知道只有那些对其生产的产品进行持续监控的公司才可以被选择加入该试点计划”。
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作者:admin@医学,生命科学 2011-02-17 18:04
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