Outline for the development of pharmaceutical pack

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The outline of the development of the pharmaceutical packaging industry during the Eleventh Five Year Plan period has been basically achieved through the joint efforts of the industry. During the Eleventh Five Year Plan period, China's pharmaceutical packaging industry has achieved great development

The 16th CPC National Congress put forward the strategic goal of building a well-off society in an all-round way and the requirements of adhering to the new road of industrialization, improving the ability of independent innovation, optimizing the industrial structure, saving resources and protecting the environment

according to the national "Eleventh Five Year Plan" and the "Eleventh Five Year Plan" development plan proposed by the pharmaceutical industry, China Pharmaceutical Packaging Association will organize to put forward the "outline of the Eleventh Five Year Plan for the development of pharmaceutical packaging (outline draft)" on the basis of analyzing the current situation of pharmaceutical packaging, and submit it to the third meeting of the Fifth Board of directors for deliberation and discussion

I. implementation of the Tenth Five Year Plan for pharmaceutical packaging

2005 is the end of the tenth five year plan. Looking back on the past five years, pharmaceutical packaging has made gratifying achievements, and the enterprise scale, product varieties and grades, and technical management level have been significantly improved. The Tenth Five Year Plan of Chinese pharmaceutical packaging organized by the association has played a positive guiding role

so far, the development goals of various dosage forms in the tenth five year plan have been basically achieved. What has been accomplished is that natural rubber plugs have been eliminated for powder injection and infusion agents, butyl has been realized, and the product quality has also been greatly improved. Develop high-quality aluminum plastic composite covers; The development of high-quality controlled bottles and light-weight molded bottles for powder injection; Develop high-quality plastic infusion containers, improve the quality of glass infusion bottles, and strictly prohibit the second use of various infusion containers; Manual production of capsules is strictly prohibited, the development of plant capsules from non animal sources is developed, and the research and development of capsule technology of new materials such as seaweed are supported; Tablets support the development and production of various high barrier materials and containers. Plastic bottles reduce the use of bottle mouth sealing film, improve the quality of glass yellow round bottles, and completely eliminate soft (broken) wooden plugs dipped in wax; Ointment completely eliminated lead tin tubes and low-quality plastic products, developed internally sprayed aluminum tubes, and supported the research of high-level aluminum-plastic composite tubes. Water injection has made great progress in improving the quality of easy to break ampoules, developing low expansion coefficient and printing ampoules, and accelerating the development of color ring easy to break ampoules, but there is a problem of thin bottle wall

the development and production of OTC product packaging have also been greatly improved, but the design of products and corporate image needs to be improved. The research and development of child safety packaging has not made much progress due to the lack of sufficient attention and the support of corresponding laws and regulations, During the "Eleventh Five Year Plan" period, it will be listed as the focus of work.

II. The current situation and situation of pharmaceutical packaging in China

1. With the promulgation and implementation of the drug administration law, the regulations for the implementation of the drug administration law and the administrative licensing law, the State Food and Drug Administration promulgated the measures for the administration of packaging materials and containers in direct contact with drugs (order 13) in July 2004 The product registration management shall be carried out for the packaging materials and containers that directly contact drugs, so as to make the management of pharmaceutical packaging enter the legal track

2. Since 2001, the State Food and drug administration has begun to formulate national standards for drug packaging materials. So far, 139 product standards and inspection method standards have been completed, and the system is basically perfect

3. The transformation of the functions of the national government is mainly the supervision of the product market, which is fully reflected by the autonomy of enterprises, but the macro-control and management of the market are absent

4. Large foreign companies have targeted the Chinese market and are gradually entering China and gradually occupying the high-end product market. On the other hand, the entry of Chinese products into the international market has been repeatedly blocked and suffered from antidumping or technical barriers from Europe and the United States

5. China's products are of low grade, high energy consumption, serious low-level repeated construction, product prices enter vicious competition, and the ability to bear market competition risks is poor

6. Weak technology R & D capability, insufficient R & D capital investment, and lack of products with independent intellectual property rights

7. As the state increases the governance of improper behaviors in medical institutions and drug sales, drug prices have a downward trend, which will affect the packaging industry to a certain extent

III. The development goal of the 11th Five Year Plan of China's pharmaceutical industry

1. In the field of chemical raw materials, through process, technology and equipment innovation, we will realize the industrialization of 20 products with great market growth potential and high added value, and form a new competitive advantage in international food markets; A number of products have truly entered the international market through international registration

2. In the field of chemical pharmaceutical preparations, strive for five preparation products to obtain the listing qualification of the United States or EU countries, and truly enter the international mainstream pharmaceutical market

3. In the field of modern traditional Chinese medicine products, there are 10 ~ 20 modern traditional Chinese medicine products with perfect quality standards, clear efficacy mechanism, safety, efficiency, stability and controllability

4. In the field of major infectious diseases and chronic serious diseases, strive to have 5-10 innovative drugs and new vaccines with China's independent intellectual property rights industrialized and put on the market

IV. outline of the "Eleventh Five Year Plan" for the development of pharmaceutical packaging in China

(I) organization and construction of the association

while continuously strengthening its own construction, the association will take protecting the interests of the industry and promoting the development of the industry as its core work, improve the functions of the association and promote the progress of the industry

1. Create a good environment to vigorously support independent innovation and establish an effective mechanism to encourage technological innovation

2. Strengthen the exchange and communication with relevant foreign industry associations (organizations) and certification institutions, timely grasp the development trend and certification requirements in the field of international pharmaceutical packaging, and create conditions for Chinese products to enter the international market

3. Establish and improve the standard system of the association, as a supplementary part of national standards and enterprise standards, which is scientific, progressiveness and practical in the industry. Fully solicit and listen to the opinions and suggestions of major manufacturers and users

4. Maintain normal market order and study and set up industry access

5. Carry out industry credit construction and promote integrity publicity and education

6. Improve the construction of the station and set up an expert mailbox to provide members with a simple and effective communication platform

7. Strengthen the publicity, implementation, interpretation and exchange of pharmaceutical packaging policies

8. Strengthen talent training, including the training of senior professionals such as laws and regulations, professional technology and testing, and staff training

(II) industry development direction

industry development goal: encourage innovation, professional and technical support of Jinan new era Gold Testing Instrument Co., Ltd. welcome information to safeguard intellectual property rights; Develop new materials, new processes and new forms of packaging, gradually improve the grade of products, closely cooperate with the development of the pharmaceutical industry, and ensure the quality and safety of drugs; Pay attention to humanized packaging, especially the elderly, children and other special groups; Attach importance to green, environmental protection and energy conservation, and build a conservation oriented society; Adjust the industrial structure, make the layout of high, medium and low-end products reasonable, and avoid the waste of resources and damage to the ecological environment caused by low-level repetition

the details are as follows:

1. Comprehensively improve the independent innovation ability of the industry, improve the industrial technology level and international competitiveness, protect leading enterprises and products, and it is suggested to set up an innovation fund

2. Continue to promote children's safety packaging, including dose safety and packaging opening safety, so as to prevent children from mistakenly taking drugs or taking inaccurate doses, and promote the formulation of corresponding regulations

3. Improve the quality and grade of pharmaceutical packaging products, meet the packaging needs of high-end drugs, and fully cooperate with pharmaceutical products to enter the international market

4. Actively develop the application of new packaging materials, new technologies and new processes in the field of pharmaceutical packaging, such as the application of biodegradable materials such as polylactic acid and plant capsules and seaweed capsules in the field of pharmaceutical packaging

5. Develop and use environmental friendly materials, deeply discuss the use and recycling of composite materials, and try to use single component recyclable materials to reduce environmental pollution

6. Develop and use advanced and reasonable packaging forms to ensure drug quality and drug safety, improve drug efficacy, and facilitate production and use:

(1) advocate selecting reasonable packaging according to the characteristics of drugs to avoid unnecessary waste of resources caused by excessive packaging

(2) the packaging dosage is diversified, and different packaging forms are designed according to the characteristics of different drugs and the dosage and mode of medication of different patients, so as to effectively avoid the waste of expired drugs

(3) develop products that can be easily opened and taken by mistake by the elderly

(4) improve the packaging design level of OTC drugs, play the role of advertising, and reflect the corporate image

7. Promote the use of RFID to improve production and logistics efficiency and prevent errors

8. Set up packaging industry certification. Plan large-scale supervision and random inspection, and set up a centralized testing center

(III) development of dosage form packaging (content undetermined)

1. High volume injection (infusion):

2. Powder injection:

3. Freeze drying:

4. Small volume injection:

5. Solid oral preparations (tablets, capsules, granules):

6. Ointment:

7. Other

Design Committee Planning:

at present, the enterprise's independent brand packaging design innovation consciousness and ability are not strong, Lack of sufficient market research, theoretical research and funding. Therefore, during the "Eleventh Five Year Plan" period, we should strengthen the innovation awareness and development ability of independent brand packaging design, establish a people-oriented design concept that emergency braking can be carried out in case of emergency, and combine science and aesthetics, so as to improve the competitiveness of enterprise style and product packaging in domestic and foreign markets. (Huang Wei)

pharmaceutical glass planning:

develop new pharmaceutical glass packaging containers or glass combination containers such as borosilicate and high borosilicate pharmaceutical glass tubes, high-strength freeze-drying bottles, silicified coating bottles, high-precision curved neck easy to fold ampoules, high-grade printing ampoules and cartridge bottles, pre filled syringes, etc. (chaojianfeng)

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