regulation(eu)2017/79
时间: 2023-10-13 13:02:46 浏览: 37
《条例(欧盟)2017/79》是欧盟针对药品的监管法规。该法规于2017年生效,旨在确保在欧洲市场上销售和使用的药品的质量和安全性。
根据该法规,任何在欧洲市场上销售药品的企业,都需要进行注册和授权。这意味着药品企业必须遵循特定的流程和要求,以确保向市场推出的药品符合法规要求。此外,药品企业还需要按照欧洲药品管理局(EMA)的规定提交相关申请和文档,以获得欧洲市场销售许可。
《条例(欧盟)2017/79》还明确规定了药品的生产、质量控制、商标和信息标签等方面的要求。它要求药品生产企业建立质量管理系统,确保药品的制造过程和产品质量得到严格控制和监督。药品在生产过程中需要经过各个环节的质量检查和测试,以确保它们符合相关质量标准。
此外,该法规还强调了对药品的监督和安全性评估的重要性。药品监管机构将负责评估药品的安全性和疗效,并监督市场上销售药品的企业的活动。如果发现药品存在质量问题或存在潜在的安全隐患,药品监管机构有权采取相应的措施,包括召回药品或暂停销售许可。
总之,《条例(欧盟)2017/79》是一项重要的欧盟药品监管法规,旨在确保药品在欧洲市场上销售和使用的质量和安全性。它要求药品企业在注册、生产、质量控制和信息标签等方面遵守特定要求,并强调了药品监管机构对药品安全性的评估和监督的重要性。这将进一步增强欧洲市场上药品的监管和保护消费者的权益。
相关问题
static regulation
"Static regulation" generally refers to regulations or rules that do not change or are fixed in nature. They are often contrasted with dynamic regulations that can change in response to changing circumstances or conditions. Static regulations may include laws, policies, or procedures that are established to provide consistency and stability in a particular system or environment. For example, a company's code of conduct or a government's constitution are examples of static regulations that are designed to guide behavior and decision-making in a consistent manner.
DCDC static regulation
DC-DC static regulation is a technique used to regulate the output voltage of a DC-DC converter without using any feedback control loop. In this technique, a fixed voltage is applied to the input of the converter, and the output voltage is regulated by adjusting the duty cycle of the converter's switch. This is achieved by using a voltage divider network and a comparator to compare the output voltage with a reference voltage. The comparator then adjusts the duty cycle of the converter's switch to maintain a constant output voltage. DC-DC static regulation is simple and efficient, and it is commonly used in low-power applications where the load is relatively constant.