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English to Chinese: Medical General field: Medical Detailed field: Medical (general)
Source text - English 心率管理问题受到重视，是因为在不同人群中进行的诸多流行病学研究显示心率增快很可能是一项重要的心血管危险因素。然而，对于高血压患者而言，心率增快是否导致靶器官损害和心血管事件增加、减慢心率后能否改善临床预后、如何规范测量心率、如何界定心率增快以及如何适当管理心率等问题均存在着较大争议。本共识认真复习相关文献，逐个讨论上述问题，提出针对我国高血压患者心率管理的共识性建议。
Translation - Chinese Heart rate management issues are valuedis accorded due attention becausein view that many a multitude of epidemiological studies in different populations have shownfound that an increase in heart rate increase is to be a likely possible to be an important cardiovascular risk factor. However, significant controversies surround hypertensive patients, namely, if increased heart rate results in target organ damage and increase in cardiovascular events, if decreasing heart rate improves clinical outcomes, how heart rate measurements should be standardized, how heart rate increase should be defined, and how heart rate can be properly managed. This consensus reviews relevant literature, addresses each of the above questions in turn, and proposes consensus recommendations for heart rate management in hypertensive patients in China. in hypertensive patients, there is so much controversy over issues as whether increased heart rate results in target organ damage and increase in cardiovascular events, whether decreased heart rate can improve clinical outcomes, how to standardize heart rate measurements, how to define increased heart rate and how to properly manage heart rate. This consensus reviews related literatures and discusses each of these issues to propose for consensus recommendations on heart rate management in Chinese hypertensive patients.
English to Chinese: Pharmaceutical Business
Source text - English With effect from 2015, China has redefined “new drug” from "new to China" to "new to the world". Under current policies, the redefinition of new drugs not only has implications on drug registration categorization, but also impacts PTE as well as data protection. Under the new definition, the first original drugs to enter China and which are authorized for marketing in other countries but have yet to be approved for marketing within China may be excluded from the scope of innovator drugs. This in turn has implications on future determination of reference listed drugs, patent registration in early resolution mechanisms in patent disputes, and determination of subsequent review waiting periods, and may impact PTE and data protection. Eventually, market regulation may be compromised.
Lastly, companies should be able to protect their technical know-how’s through trade secret protection mechanisms. For pharmaceutical companies, it would mean protecting drug manufacturing information from theft. This includes ensuring security in submitting confidential information for administrative and regulatory purposes.
In conclusion, to raise the level research and development of new drugs in China and facilitate the globalization of innovative enterprises, we seek cooperation and commitment from all parties in jointly tackling the current challenges, in an effort to build and improve China’s pharmaceutical intellectual property protection system. To this end, we recommend:
1. Including innovator medicinal products that have been authorized for marketing in China based on safety and efficacy data (including medicinal products that are authorized for marketing in other countries but yet to be authorized for marketing within China) under the scope of protection of PTE, RDP, and other intellectual property rights as innovator drugs;
2. Formulate patent review and patent invalidation standards consistent with that of advanced international markets.
3. Establish a drug trial data protection system consistent with global best practices.
Conclusion
China is at an important historical juncture of rebranding itself from an important pharmaceutical country to a leading pharmaceutical country. Hence, we need to have foresight and build upon what we have already accomplished, and strive towards further development and higher quality through in-depth reformation, further opening up of our market, and international cooperation. Looking ahead to the next five years, we hope all sectors can work together in a collective effort to tackle the existing deep-seated challenges and promote the sustainable development of China's pharmaceutical innovation ecosystem:
• Promote concurrent research and development, registration, and review of innovator drugs to facilitate “international integration” and drive innovative development;
• Build a diversified security system to safeguard the benefits of "People's Health”;
• Establish and improve the legal system for medicinal product intellectual property protection to ensure effective protection of the patents and experimental data of new drugs in all departments and in every link.
• Drive sustainable development of “innovative industries” through highly efficient clinical studies and regulatory review, diversified protection, and intellectual property rights protection, and thereby benefit patients through the development of more breakthrough innovative new drugs.
Member since Jun '23
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