The 12th Five Year Plan for pharmaceutical packaging is about to be launched. Li Hong, director of the Department of consumer products industry of the Ministry of industry and information technology, told China Securities News on the 20th that as one of the important sub plans, the 12th Five Year Plan for pharmaceutical packaging is expected to be issued together with the 12th Five Year Plan for the biomedical industry in the near future
at the 2011 Pharmaceutical Packaging Summit Forum hosted by the China Pharmaceutical Packaging Association on the same day, Cai Hong, vice president of the China Pharmaceutical Packaging Association, who participated in the formulation of the plan, introduced that the 12th Five Year Plan for pharmaceutical packaging (hereinafter referred to as the "plan") contains five key contents, and the compatibility of packaging materials will be the key work of the regulatory authorities in 2012. According to reports, the total output value of pharmaceutical packaging in China reached 35billion yuan in 2010
focus on the development of 8 kinds of packaging materials and compatibility
Cai Hong said that the compatibility of drug packaging materials foam granulator will be a major task that domestic pharmaceutical companies will face soon, and it is one of the five key contents of the plan
since 2012, the State Food and Drug Administration will focus on promoting the compatibility research and safety evaluation of packaging materials. Establish evaluation procedures and methods for pharmaceutical battery pack packaging materials suitable for despicable environments to ensure the safety and effectiveness of pharmaceutical packaging materials
Gao Juan, chief scientific adviser of Shanghai New pioneer pharmaceutical company, said that with the full implementation of made in China 2025, the compatibility of drug packaging materials becomes more important with the implementation of the new version of GMP, because there is the possibility of chemical reactions between packaging materials and drugs, resulting in potential risks
The experimental machine in1 has three levels of 0.5/1/2 poles. On October 19, the drug examination center of the State Food and drug administration has discussed the newly formulated guiding principles for the compatibility of pharmaceutical packaging materials for chemical injections for the first time, which is expected to be issued soon
other key contents of the plan point out that in the next five years, China's pharmaceutical packaging industry will focus on the development of new, environmentally friendly, degradable and convenient pharmaceutical packaging materials and containers. Including eight kinds of packaging materials, including grade I water-resistant medicinal glass products, pre filled syringes, multi chamber bag infusion packaging and other self-contained drug delivery devices, packaging materials suitable for the quality requirements of traditional Chinese medicine and decoction pieces, PVC alternative products and technologies, pharmaceutical packaging materials with temperature memory function, drug child safety packaging, and packaging forms and materials convenient for the elderly and disabled
accordingly, the production of special raw and auxiliary materials for packaging materials will be upgraded. The plan requires that special raw and auxiliary materials, additives and accessories for pharmaceutical packaging materials be actively developed, including raw and auxiliary materials with high cleaning and high processing properties, plastic resins for injection blowing and filling (BFS) production process, clean and sterile packaging films, etc. The plan also encourages the development and application of production equipment for pharmaceutical packaging materials and containers that meet GMP requirements, have independent intellectual property rights and advanced technology; Promote the formulation and implementation of production quality management specifications for pharmaceutical packaging materials
focus on controlling the scattered and disordered pattern of the industry
the data provided by the China Pharmaceutical Packaging Association shows that at present, there are more than 1500 manufacturing enterprises in the field of pharmaceutical packaging in China, with more than 3200 product registration certificates, which can produce more than 90% of packaging products. In 2010, 26% of enterprises exported their products. More than 20 products are active in the FDA filing. More than 55% of enterprises have patents, including 30 independent invention patents
however, the domestic pharmaceutical packaging industry has prominent problems. It is mainly manifested in the large number and small scale of enterprises, the low level of equipment, technology and management, and the serious repetition of low-level middle and low-end products; Weak independent innovation ability; The research on the safety of drug packaging materials and their compatibility with drugs is not deep enough; Lack of talent training mechanism and shortage of high-tech talents; Lack of standardization strategy and system
Shandong YAOBO (600529) once said in the mid-2011 report that the current net profit decreased by 10.93% due to the partial production restriction of the downstream pharmaceutical industry, the rising price of upstream resource raw materials and chemical products, and the disorderly competition in the same industry. With the rapid development of the pharmaceutical industry, the capacity expansion of the domestic pharmaceutical packaging industry has been completed, and a new round of competition has begun, bringing great pressure to the company
therefore, the plan will strive to promote the coordinated development of the industry and the pharmaceutical industry, raise the threshold of industry access, reduce low-level repeated construction, formulate industry standardization strategies, and cultivate internationally competitive pharmaceutical packaging enterprises
some pharmaceutical packaging enterprises also began to speed up the development of new products and optimize the product structure. Qianshan pharmaceutical machine (300216) was the first in China to launch a plastic ampoule injection bottle making, filling and sealing machine in 2011, with a production capacity of 9000 pieces/hour, which has attracted the attention of pharmaceutical enterprises. Zhejiang Pharmaceutical Packaging Industry Association said that at present, China has imported more than 50 plastic ampoule injection bottle making, filling and sealing machine production lines, and the imported equipment is about 10000 yuan/set
the plan also puts forward that the main task of the pharmaceutical packaging industry in the next five years is to formulate laws and regulations on the safe packaging of drugs for children; Promote energy conservation, emission reduction and cleaner production; Implement electronic supervision code for drugs; Set the threshold of industry access and create a fair competition environment for enterprise development; Strengthen the statistical work of the pharmaceutical packaging industry
at present, the listed companies involved in pharmaceutical packaging in a shares mainly include Shandong YAOBO, Qianshan pharmaceutical machinery, Kelun Pharmaceutical (002422) and Huaren Pharmaceutical (300110)
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