Medical website September 13
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Curative effect for the implementation of the general administration of quality of generic drugs and announcement of relevant matters of consistency and evaluation, organized by the national center for human medicinal the directory listed Chinese medicine "(draft), the deadline until September 15, 2017.
The directory listed Chinese medicine set (draft) "issued caused wide public concern in the industry, from the previous" about to encourage pharmaceutical medical equipment innovation policies of protection of innovators (draft) "opinions of the announcement no. 55 (2017) put forward" to establish the listed drugs directory set no more than four months time "requirements, is established by the competent department of the listed drugs directory set of determination and efficiency.
The establishment of a catalogue of listed medicines in China is a reflection of the further deepening of the regulatory information disclosure. From the solicitation draft, the listed drug catalog has four functions:
The first is to improve the availability of drugs by promoting the substitution of generic drugs. The second is to protect the legitimate rights and interests of patentee and reduce the risk of patent infringement by listing patent and exclusive information. Third, the standard of generic drugs is determined by the equivalent type of generic drug. Fourth, promote supporting patent links, patent challenges and patent term compensation systems, and implement data protection (exclusive period) system.
In the opinion draft, the range of catalogs is not all listed medicines that have been approved.
First, new drugs, improved new drugs and imported drugs are to be approved based on the safety and validity of the full specifications. From this statement, it may be considered that the variety, including the declaration of the work programme on the reform of the registration of chemical drugs, (no. 51 of 2016), may also include the varieties after the announcement of no. 51. Second, generic drugs include generic drugs approved under the new registration classification of chemical drugs (after the 51st announcement) and medicines that are evaluated by quality and efficacy. Once again, whether the Chinese medicine, biological products are included, the draft opinion is not clearly defined, and the other drugs identified by the CFDA are summarized to allow room for future adjustments.
It found that the information listed in the listed drug catalog includes: drug approval basic information and generic equivalent information, patent and exclusivity period information.
Combined with previous work, and the review carried out examination and approval, the difficulty of the former two pieces of information listed, the patent and exclusivity period information is difficult, because the relevant supporting system has not yet been established, the lack of laws and regulations.
Orange Book making experience, from the United States on the patent is limited to the DS (Drug Substance), Drug patent DP (Drug Product), including prescription and preparation (COMPOSITION/FORMULATION) patent, patent Drug USE U () METHOD OF USE, for which the patent on, which will not be included in the, has a definite limit. China's listed drug catalog is still to be refined.
Similarly, the inclusion of data protection information needs to be detailed policy. In order to better include information on patent and data protection, it is recommended that the quality and type of drug patents be included in the proposed research to be included in the standard.
In addition, the listed drug catalog should be a summary of dynamic information, and information about drug withdrawal and stop listing should also be included. At present, the opinion draft is only a framework of the listed drug catalog, which can be used to search for reference in the industry.
Let's say a couple of >, >, >
Add code patent link
Innovative drug research and development, with large investment, high difficulty, long cycle characteristics, new drug research and development enterprise needs the protection of the patent system, by giving the lawful rights and interests of the patent system, gain market monopoly profits, can recover the development cost, and can cause drug firms continue to research and development of new drugs, patients can get better treatment, of course, also has brought the problem of high burden of new drugs.
"Directory" in the system of drug patent links, is a line with Europe and the United States and other developed countries patent medicine management system, on the basis of full respect for drug patents, by reducing the generic infringement risk, accelerate the generics market, the process to tame prices, improve the purpose of drug accessibility. This practice conforms to the international practice and the legal system of our country.
In the patent law of China and the drug registration administration measures, the relevant provisions of the patent links of medicines are included in the patent law.
In the directory set draft, drug patent links including patent information, approval/registration number, patent number, patent type and patent expiration date, patent cancellation, patent information, information about basic include drug patents. But the author thought that, as at present, China's pharmaceutical patent operation and management level and there are still certain gaps when compared with multinational drug companies, if only basic patent links, such as chemical medicine basic patent, patent may expire, namely its compounds and preparation for patent is not maturity, hidden traps. If the patent on the drug's longitudinal extension and lateral expansion of protection is still not due, it could be a patent infringement if the drug is developed.
Therefore, it is recommended that patent links not only include basic patents but also other patents related to the drug. As a result, drug companies can make generic patents more quickly and do not infringe on other patents related to the drug and are more operable. (qin weihua)
It is recommended to administer according to the chemical medicine/traditional Chinese medicine
The publication of the catalogue of Chinese listed medicines is another major step in the management of pharmaceutical affairs in accordance with international standards. Read the "draft for comment", which is similar to the American Orange Book.
The Orange book includes all the drugs approved by the FDA, known as drugs approved for the treatment of the same sex. There is no doubt that treat drug approval after the examination and approval system gradually perfect, based on the basic demands, the quality of the drug in combination with dynamic management, in the near future, for the directory of all drugs must be conform to the requirements of the specific technology in safety and effectiveness, has the competitive advantage.
Drug entry is a kind of identification, according to the information that is listed in the drug, consumers can target the product of the target drug relative to the objective region. The introduction of the catalogue of listed medicines in China is the supporting promotion of the implementation of the "registration of drugs registration" and the implementation of the "listed license holders system" in the operation.
This "draft" involved in drugs, seems to be confined to chemicals, in view of China's listed drugs with chemical medicine (including biological products), traditional Chinese medicine (TCM), some specific technical requirements on the difference between the two is objective existence. According to the Chinese pharmacopoeia, the catalogue of listed drugs in China is dynamically managed by chemical and traditional Chinese medicine. If "Chinese listed medicines catalog" (one or two), if "one" represents "chemical", "two" means "traditional Chinese medicine". Traditional Chinese medicine can be divided into innovative medicine, classical prescription, medical institution preparation, Chinese medicine master or expert experience. Clinical divide, can press "disease union" use, press "syndrome" use, press "disease" special disease special disease to divide. In quality control, it can be divided into "standard decoction", consistent with "standard preparation", all of its flavor from daodi, all from standardized planting base etc. (by Chen)
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