Outline of the tenth five year development plan fo

The outline of the Tenth Five Year Plan for the development of the pharmaceutical packaging industry

China's pharmaceutical packaging industry has developed rapidly in the 20 years after the reform and development, and has attracted more and more attention. Pharmaceutical packaging is a unique industry with multi-disciplinary, multi professional and multi industry integration and special requirements. In the face of global economic integration and China's entry into WTO, we must realize industrial modernization and informatization as soon as possible, and the next five years is the key period for the pharmaceutical packaging industry to achieve faster development. Therefore, the correct prediction and guidance of the "Tenth Five Year Plan" of the pharmaceutical packaging industry will play a vital role in the healthy development of China's pharmaceutical packaging industry

current situation of pharmaceutical packaging industry

(I) enterprise product structure

there are about 1500 enterprises, which can produce more than 50 varieties of pharmaceutical packaging materials in six categories, with an annual output value of about 15 billion yuan, which can meet more than 80% of the needs of domestic pharmaceutical enterprises. However, at present, the overall level of pharmaceutical packaging in China still lags behind developed countries, and the quality of packaging materials and the contribution rate of packaging to the pharmaceutical economy are significantly lower than the international level. The proportion of packaging and drug value in developed countries is about 15% - 25%, some as high as 30%, while China only accounts for 8% - 9%

in 1992, the State Pharmaceutical Administration implemented a license system for drug packaging material manufacturing enterprises that directly contact drugs. After two license renewals in 1995 and 1997, the enterprise structure is roughly as follows:

1. Pharmaceutical glass manufacturing enterprises: 417 (about 28%)

2. Plastic (aluminum) container manufacturers: 278 (about 18%), of which: 33 produce traditional Chinese medicine spherical shells

3. There are 165 enterprises producing sheet, film and foil (composite) materials (accounting for about 11%), including 36 enterprises producing medicinal PVC hard sheets and 35 enterprises producing PTP aluminum foil

4. Gelatin hard capsules: 116 manufacturing enterprises (about 8%), including 3 enteric coated capsules

5. 118 pharmaceutical rubber stopper manufacturers (about 8%), including 11 butyl rubber stoppers and 110 natural rubber stoppers

6. All kinds of bottle caps: 185 there will also be a certain difference in the experimental equipment suitable for different pipes. Start the machine at home every hour (about 12%)

7. There are about 200 other manufacturers (ointment tube, desiccant, eye medicine bottle, etc.)

the production of drug outer packaging (paper products, plastic products, metal products, decorative prints) and other related products has also formed an enterprise group, which is increasingly emerging in ensuring the safety and convenience of medication and improving the commercial value of drugs

(II) standardize the legal construction of the pharmaceutical packaging industry

the legal construction of China's pharmaceutical packaging industry

the legal construction of China's pharmaceutical packaging industry started late. Since the State Administration of Medicine issued the measures for the administration of drug packaging (Trial) on January 13, 1981, order No. 10, namely, the measures for the administration of the production of materials and containers for drug packaging (Trial), was issued on May 28, 1991. On June 14, 1996, the State Drug Administration was established. On April 29, 2000, order No. 21 of the State Drug Administration, namely, the measures for the administration of drug packaging materials and containers (Provisional), was issued, On October 15, 2000, Decree No. 23 was issued, that is, the provisions on the administration of drug packaging, labeling and instructions (Provisional)

the State Drug Administration reiterated that the former State Drug Administration's gyzz [95] No. 8 notice on eliminating some natural rubber antibiotic corks and adopting medicinal butyl rubber antibiotic corks and gyzz [95] No. 552 decision on eliminating backward drug packaging such as lead tin ointment tubes in the early stage of the ninth five year plan, which were successively issued in 1995, are still valid, and are strictly managed in accordance with the provisions of order 21

existing problems

the problems existing in China's pharmaceutical packaging industry are multifaceted, mainly enterprise structure and product structure problems, which are manifested in low-level duplication, serious unreasonable resource allocation and capital allocation, etc. Market chaos has not been effectively curbed for a long time

1. The legal system construction is not perfect

2. Product sales lack sufficient credit, which makes it difficult to ensure that advanced and high-quality packaging products are introduced to pharmaceutical enterprises in a timely manner

3. It is difficult for leading enterprises and backbone enterprises in the pharmaceutical packaging industry to play a leading role in standardizing the market

4. Compared with similar international products, there is a big gap in both internal and external quality of most packaging materials produced in China

5. New product development and scientific research are backward, there is a lack of scientific and technological personnel in the pharmaceutical packaging industry, which accounts for a low proportion of the total number of employees, and scientific research funds and scientific and technological forces are insufficient

development policy

the "Tenth Five Year" development policy of the pharmaceutical packaging industry is to accelerate the adjustment of product structure, strengthen product development, thoroughly implement the "order 21", promote the further implementation of the quality management system, and meet the needs of pharmaceutical enterprises for the development of pharmaceutical packaging

(I) improve the overall level of the pharmaceutical packaging industry to meet the needs of pharmaceutical enterprises to implement GMP

(II) improve the capacity and level of domestic pharmaceutical packaging production equipment

(III) accelerate the construction of informatization and promote the reform and development of pharmaceutical packaging enterprises

further strengthen the construction of the legal system

being unable to abide by or failing to abide by the law is a difficult problem that has plagued the pharmaceutical packaging industry for a long time, and an important factor that causes market chaos and hinders the progress of the industry. During the Tenth Five Year Plan period, the pharmaceutical packaging industry should adapt to the general environment of national legal system construction, promote the coordination and interaction of enterprises, associations and governments, strengthen the construction of democracy and legal system, maintain market order and protect fair competition

development policy

the association should actively cooperate with relevant national departments to formulate various preferential policies on research, development and production of advanced pharmaceutical packaging to support the development of advanced pharmaceutical packaging

1. We should strengthen the research on the impact of pharmaceutical packaging waste on the environment, support the development and production of environmentally friendly packaging products, and explore the application of polymer degradation in pharmaceutical packaging

2. Support the development and production of OTC packaging

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4. Powder injection (including biological, biochemical and freeze-drying): develop high-quality tube bottles and light-weight molded bottles, speed up the elimination of natural rubber corks, realize butyl on the basis of steadily improving the quality level of butyl rubber corks, and develop high-quality aluminum-plastic composite caps

5. Water injection: improve the quality of easy break ampoules, develop low expansion coefficient and printing ampoules, and speed up the development of color ring easy break ampoules

6. Infusion packaging: develop high-quality plastic infusion containers, improve the quality of glass infusion bottles, and strictly prohibit the second use of various infusion containers. Eliminate natural rubber plugs, promote butyl rubber plugs, and develop high-quality aluminum-plastic composite covers

7. Capsules and tablets: strictly prohibit the production of manual capsules, and strengthen the supervision and inspection of capsule production quality and health indicators. Vigorously develop the development of green capsules of non animal capsule types, and support the technological research and development of seaweed capsules. Support the development and production of various high barrier composite materials and containers. The sealing performance of plastic bottles should be achieved by improving the accuracy of molds and other technical means to reduce the use of bottle mouth sealing film. Improve the quality of glass yellow round bottles, and completely eliminate soft (broken) corks dipped in wax

8. Ointment: completely eliminate lead tin tubes and low-quality plastic products. Develop internally sprayed aluminum tubes. Support the research of high-level aluminum-plastic composite pipe on the premise of taking into account the requirements of environmental protection and medicine

9. Cooperate with the development of dosage forms, research and develop pharmaceutical packaging materials