美英兽药GMP检查互认

PharmLink

The U.S. Food and Drug Administration (FDA) and the United Kingdom’s Veterinary Medicines Directorate (VMD) are announcing today their decision to expand the scope of the U.S.-UK Mutual Recognition Agreement (MRA) Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMP) to include inspections of veterinary pharmaceuticals (also called “animal drugs”). This MRA entered into force on January 1, 2021, but initially included only pharmaceuticals intended for human use. Today’s action to include animal drugs in the MRA is an important step in ensuring the safety and quality of animal drug products and will enhance efficiencies for the U.S. and UK regulatory systems.
美国食品和药物管理局 (FDA) 和英国兽药管理局 (VMD) 今天宣布决定将美英相互承认协议 (MRA) 药品优良生产规范 (GMP) 部分附件的范围扩大到包括对兽药（也称为“动物药”）的检查。该 MRA 于 2021 年 1 月 1 日生效，但最初仅包括供人药。今天将动物药纳入 MRA 的行动是确保动物药物产品安全和质量的重要一步，并将提高美国和英国监管系统的效率。


An MRA is an agreement between two or more countries to recognize a specific process or procedure of the other country, and this is the first step toward strengthening use of each other’s animal drug inspection expertise and resources. The overall goal of the MRA is to produce greater efficiencies for both regulatory systems and provide a more practical means for both the FDA and the VMD to oversee the facilities that manufacture animal drugs in these locations. By utilizing each other’s inspection reports and related information, an MRA can ultimately enable the FDA and VMD to avoid duplication of some animal drug inspections and enable regulators to devote more resources to other areas where there may be greater risk.
MRA 是两个或多个国家之间达成的协议，以承认对方国家的特定流程或程序，这是加强利用彼此动物药品检验专业知识和资源的第一步。MRA 的总体目标是提高两个监管系统的效率，并为 FDA 和 VMD 提供更实用的手段来监督在这些地方生产动物药物的设施。通过利用彼此的检查报告和相关信息，MRA 最终可以使 FDA 和 VMD 避免一些动物药品检查的重复，并使监管机构能够将更多资源投入到可能存在更大风险的其他领域。


Over the past several months, the FDA has taken numerous steps to prepare for expanding and implementing the MRA’s coverage to include animal drugs. This has included, among other things, sharing information with the UK about FDA’s Center for Veterinary Medicine’s oversight of animal drug manufacturing in the U.S.; observing an audit performed by European Union auditors of an inspection that was conducted by a VMD inspector; and conducting an evaluation of the UK’s regulatory framework, which found the UK has the capability, capacity and procedures to carry out routine GMP surveillance inspections that meet FDA requirements for animal drugs.
在过去的几个月里，FDA 采取了许多措施来准备扩大和实施 MRA 的覆盖范围，以包括动物药物。其中包括与英国分享有关 FDA 兽医中心对美国动物药物生产监管信息；观察欧盟审计员对 VMD 检查员进行的检查进行的审计；并对英国的监管框架进行评估，发现英国有能力、能力和程序进行常规 GMP 监督检查，以满足 FDA 对动物药物的要求。


文章来源：https://www.fda.gov/animal-veter ... -good-manufacturing