The Central Office and the State Council issued the "Opinions on Deepening the Reform of the Examination and Approval System to Encourage the Innovation of Pharmaceutical Medical Devices" (hereinafter referred to as the "Opinions"), and launched a package of policies and measures to benefit China's pharmaceutical innovation.
If the reform of clinical trial management is likened to “laying high-track†and the reform to speed up the review and approval of listing is likened to “ignition accelerationâ€, then the reform to promote the development of pharmaceutical innovation and generic drugs is to ensure the standardized operation of “innovative motor trainâ€. The purpose of the "safety rules" is to relieve the "worry" of drugs. This is a highlight of the "Opinions" in the design of the system, and it is also the focus of our work to implement the "Opinions."
As we all know, new drugs have large investment in research and development, long cycle and high risk. For example, only a few ten thousandth of the selected compounds can be marketed; only one-tenth of the clinical trial projects can be successfully listed. Even for generic drugs, the FDA's first-round approval rate is less than one-tenth. Despite this, once the new drug is on the market, it is a high return. Whether the realization of market expectations can be achieved depends on whether intellectual property rights can be protected.
Without the protection of intellectual property, there is no innovation. One of the important reasons for the weak drug innovation in China is that intellectual property protection is not in place. For a long time, some people have illegally encroached on the intellectual property rights and innovations of others under the control of the misconception that "creating is better than imitation, imitation is better than taking off", seriously polluting the "innovation ecology" and becoming the "heartache" of drug developers. Worried about it."
Innovate the topic, reform and make a fuss. There are five aspects related to intellectual property rights in the Opinions: First, establish a catalogue of listed drugs for reference by doctors and pharmacists. The second is to explore the establishment of a drug patent link system to reduce the legal risks after the listing of generic drugs, and to protect the rights and interests of patent owners. The third is to carry out pilot projects for the compensation period for pharmaceutical patents. The fourth is to establish a priority review system for patent compulsory licenses to meet the special needs of public health when it is seriously threatened. The fifth is to improve and implement the drug test data protection system. Through the above measures, the formation of "combination boxing" to protect the intellectual property rights of pharmaceuticals, while protecting the legitimate rights and interests of patent holders and stimulating the vitality of innovation, encourages imitation, guides imitation and standardization of imitation.
Why solve problems? Only reform; why? Only responsible. The enterprise is the main body of the market and the main body of innovation. It is necessary to fulfill the main responsibility in releasing the “worry for the researchersâ€. At the same time, the government must be brave in the fight against drug abuse, especially in supporting the clinical application of new drugs. There must be policies, measures, and methods to encourage medical institutions to prioritize the procurement and use of new drugs with clear curative effects and reasonable prices. The drugs that the party and the government are leading to create a “Chinese ecology†will inevitably lead to a large number of “global new†and quality-effective drugs that benefit patients compared with the original generics.
Bolt seals are also known as container seals. It is a metal mechanism security seal used on the container door bars to ensure the container will not be opened by any unauthorized actions.
The bolt seals sometimes is called bullet seals due to the shape of the bolt pin. According to ISO 17712 standard, the bolt seals shall be classified to High security grade then it is qualified to be called high security seals. Except the basic size requirement, the bolt seal has to reach the minimum requirements on the tensile test,impact test, bending test and shear test.
Haoshi is the professional security seals manufacturer. We offer high quality products, good service and good price.
Metal Bolt Seals,Bolt seals Bullet Seals,Bolt Seals Container Seals,Container Seals
Wenzhou Haoshi Light Industrial Products Co., LTD , https://www.economicseals.com