The standard of evaluation of the consistency of biological agents has not yet been issued, and the members suggested that its relevant policies should be improved first.

The centralized procurement and use of drugs is a breakthrough to further deepen the reform of the medical and health system, at this stage, China has established a consistency evaluation standard for chemical sines, but has not yet issued a quality consistency evaluation standard for structurally complex drugs, including biological agents.
to this end, Wu Hao, a member of the National Committee of the Chinese People's Political Consultative Conference (CPPCC) and director of fangzhuang Community Health Services Center in Fengtai District, submitted to the three sessions of the 13th CPPCC National Committee the proposal on strengthening market supervision and consistency evaluation standards for special preparations such as vaccines and biologics, and steadily advancing the national policy on the procurement of drug concentration. In his proposal, Wu Hao, a member of the
, pointed out that at present, the State Medical Insurance Administration has carried out two batches of three volume procurement projects, which have been implemented on the ground, and achieved positive results, playing a positive role in reducing the price of inflated drugs, reducing the burden on the masses, and promoting the continuous deepening of the reform of the medical and health system.
the current range of drug varieties are still mainly chemical drugs, before steadily expanding the variety of collected drugs, for vaccines, biologics and biological analogies and other special preparations, should be established a strict quality evaluation and market supervision mechanism. Wu Hao, a member of the
, said that the quality of medicines is vital to the safety of the people's drug use, which also affects the effectiveness of the implementation of the importance of procurement policies, and vaccines, biologics and other special drugs are particularly special.
such special agents are more complex than ordinary chemicals in drug structure, production process and circulation channels, and have a significant impact on the safety of patients' drug use, and many governments have introduced special management measures for the replacement of similar substances of such drugs.
2015, the former State Administration of Food and Drug Administration issued the Technical Guidelines for the Development and Evaluation of Biosimilar Drugs (Trial), which provided standardized guidance and standardized research and evaluation of biosimilar drug research and development and evaluation of relevant registration requirements such as the declaration procedure, registration category and reporting data for biosimilar drugs, with the aim of promoting the healthy development of the biopharmaceutical industry, but did not form a consistency evaluation system similar to chemical generics.
to improve the mechanism of belt procurement, Wu Hao in the proposal to give specific recommendations, establish a scientific and comprehensive consistent evaluation standards, and continuously improve the safety of patients' drug use, including strengthening the quality supervision and guidance of special preparations and drugs such as vaccines and biologics, improve and strictly implement various market supervision and management measures; Basic drug safety drugs to strengthen market supervision and access, as soon as possible to issue the biological agents and biosimilardrugs consistency evaluation and replaceable standards, strengthen the cooperation with the National Health Insurance Administration in policy, jointly steadily and orderly promotion of vaccines, biologics and other drugs collection work, in helping patients reduce the burden of drug use at the same time fully guarantee the patient's drug safety.
Extended Reading: The biologics market is about to explode, filling equipment is well known, the global pharmaceutical market can be divided into two parts: chemical drug market and biologics market.
in recent years, it is clear that the growth rate of biologics has outpaced the growth rate of chemical drugs.
data show that the size of the biologics market increased to $242.2 billion in 2017 from $164.2 billion in 2012, with a compound growth rate (7.7%) well above the pharmaceutical market as a whole (4.7%).
industry expects it to continue to grow at 9.7 per cent, reaching a market size of $350.1 billion by 2021.
the above data can be seen, the future of the biologics industry is very promising.
, as a result, drug companies around the world are now working on drug development in this area.
and the domestic pharmaceutical companies in the big pharmaceutical countries will certainly not let go of this "big cake".
data show that since 2000, China's listed mono-anti-drug drugs have more than 20, biological products declaration is three consecutive years accounted for more than 10%, has replaced Chinese medicine has become China's drug research and development of the second largest category.
at the same time, with the expansion of the biological agents market, related filling production equipment is also ushering in the development opportunities.
it is understood that filling equipment is a very important type of packaging equipment, especially in the production of pharmaceutical agents is particularly important.
from the degree of automation of production, can be divided into semi-automatic filling machine and automatic filling line, from filling materials can be divided into liquid filling machine, paste filling machine, powder filling machine, particle filling machine.
because of the wide variety of devices, the application is very wide.
at present, in addition to pharmaceutical, in the food, chemical and other industries have a great degree of application.
it is worth noting that the current domestic filling production line prospects are very substantial, but due to the industry started late, and weak technology, compared with foreign countries there is still a big gap.
in addition, some enterprises to introduce foreign technology but not to digest, absorb, ignoring the real needs of domestic users, resulting in equipment because of expensive, not in line with market demand and other reasons are not adopted from time to time.
to this, industry experts say that only to meet market demand for the filling line can better develop in the country, and the market accepted.
in recent years, the domestic demand for filling production lines, as well as in the context of continuous innovation in packaging technology, by the foreign good packaging automation concept, the domestic filling machine industry is constantly through innovation to design and technology for new upgrades.
the author learned that in the filling industry, operation automation, intelligence, etc. has become a large number of users choose equipment when the new requirements, but also become more and more filling equipment enterprises to develop the direction.
For example, now, the market has launched a fully automatic disinfection liquid filling machine that can reach 20-50 bottles per minute (depending on workload) workload, which can be 24 hours non-stop to step up production, both efficient and quality assurance.
at the same time with a high degree of automation, stable performance, production speed, accurate filling, simple operation, adaptability and so on, but also better to meet the needs of rapid production of biological agents, precision filling.
, in addition to the recent announcement that its preparation four plant (DP4) robot aseptic biologics filling line has successfully completed two batches of pre-filled needle filling.
with the Vanrx SA25 equipment, two batches of pre-filled needles can be filled at a rate of 30 bottles per minute per needle, with a pass rate of up to 99.1%.
because through intelligent means can be completed through the whole process in the closed system, without glove isolators and human intervention, can achieve high stability filling accuracy and excellent aseptic protection level, delivery of higher quality preparation products.
in general, with the rapid development of the food industry and the pharmaceutical industry and the daily chemical industry, the demand for packaging, filling machinery and equipment will continue to grow compared with the past.
at the same time, the market competition will become increasingly fierce, related enterprises want to create greater benefits, we need to keep pace with the times, and constantly learn new technologies, and some new advanced technology applied to production, in order to better meet customer needs, in the market to obtain more opportunities.
Source: CPPCC.com, Pharmaceutical Network.