美国兽药“The Minor Use and Minor Species Animal Health Act of 2004

beiwei5du

美国三种鼓励minor use and minor species的新药政策，
1、第一种为有条件批准的药物（未正式批准，但是可以暂时合法销售）；
2、第二种是基于孤儿药政策的鼓励性新药研发（通过给予优惠政策加以激励）；
3、第三种为可以不被正式批准而可以合法销售的制定用途药物
现在国内兽药行业还没有这方面的规定，只在《兽药批准文号管理办法》（征求意见稿）中提到
“第十八条  国内重大动物疫病防控急需的兽药产品，可核发临时兽药产品批准文号，临时兽药产品批准文号有效期不超过2年。”
也是针对的是突发公共事件，对于多数种群的罕见病或少数种群的疾病的关注几乎没有，希望进一步完善！！

The Minor Use and Minor Species Animal Health Act of 2004

“The Minor Use and MinorSpecies Animal Health Act of 2004,” commonly referred to asthe “MUMS act”, was signed into law on August 2, 2004. The law is intended tomake more medications legally available to veterinarians and animalowners for the treatment of minor animal species and uncommondiseases in the major animal species.

This law provides innovative ways to bringproducts to market for these small populations and is designed to helppharmaceutical companies overcome the financial roadblocks they face in providinglimited-demand animal drugs. Before this legislation,pharmaceutical companies could rarely afford to bring such drugs to market,because the markets were too small to generate an adequate financial return.

The law modifies the Federal Food, Drug and Cosmetic Act inthree key ways to provide for:

CONDITIONALAPPROVAL:  A sponsor of a veterinary drug for aminor use or minor species can apply for “conditionalapproval,” which allows the sponsor to make thedrug available before collecting all necessary effectiveness data, but after proving the drug is safe in accordance with the fullFDA approval standard and showing that there is a reasonable expectation ofeffectiveness. The drug sponsor can keep the product on the market for up tofive years, through annual renewals, while collecting the remaining requiredeffectiveness data. This provision is managed by the Office of New Animal DrugEvaluation (ONADE), not by the Office of Minor Use & Minor Species AnimalDrug Development (OMUMS).

DESIGNATION: This provision wasmodeled on the “Orphan Drug Act” for humans, which encourages pharmaceuticalsponsors to develop drugs for rare diseases in people, by providing incentivesfor approval. Sponsors of “designated” new animal drugs are eligible to applyfor grants to support safety and effectiveness testing. A sponsor that gainsapproval or conditional approval for a designated new animal drug receivesseven years of exclusive marketing rights, which means the sponsor will face nocompetition from another sponsor marketing the same drug in the same dosageform for the same intended use for that time. More information on DrugDesignation.

INDEXING:  In some cases, aminor species drug is intended for use in species that are too rare or toovaried to be the subject of adequate and well-controlled studies in support ofa drug approval. In such cases, FDA may add the intended use to the Index ofLegally Marketed Unapproved New Animal Drugs for Minor Species (the Index).This provision is especially helpful to veterinarians treating zoo orendangered animals or classes of animals that include numerous different species,such as ornamental fish. This provision is limited to minor species that arenot used as food for humans or other animals. More information on DrugIndexing.

孙艳红

需要向先进国家看齐，完善特殊审批流程

syhorchid

谢谢分享

土豆王

感谢分享，学习一下。

wct0526

感谢分享，学习一下。