Abstract:With the implementation of the registration and approval system for pharmaceutical packaging materials, the development of China's pharmaceutical packaging industry has entered the fast lane, at present, pharmaceutical packaging has now developed into a multi-disciplinary and multi-professional industry, which is an indispensable part of the pharmaceutical industry, and pharmaceutical metal packaging, as one of the important components of pharmaceutical packaging, has also ushered in a golden period of development, and the market size of China's pharmaceutical metal packaging industry will reach 13.474 billion yuan in 2022, a year-on-year increase of 5.84%.
1. Definitions, advantages and disadvantages
Pharmaceutical packaging mainly refers to the packaging of pharmaceutical preparations, which is an indispensable part of drugs and runs through the whole process of drug production, circulation and use. According to the different materials, pharmaceutical packaging materials are mainly divided into plastic, glass, rubber, metal and other types, among them, metal packaging materials are composed of metal elements, compared with other materials, metal has excellent mechanical properties, high strength, good rigidity, its container can be thin-walled or large-scale, and suitable for the packaging of dangerous goods; Excellent barrier property and long shelf life; The advantages of good processing (molding) performance of finished products and high productivity of can making and filling make it widely used in the field of pharmaceutical packaging.
Second, industry policies
1. Industry authorities and self-regulatory organizations
The competent authority of the pharmaceutical metal packaging industry is the State Food and Drug Administration. The main responsibilities of the State Food and Drug Administration are: formulating policies, plans and supervising the implementation of policies for the supervision and management of drugs and pharmaceutical packaging materials, and participating in the drafting of relevant laws, regulations and departmental rules; Responsible for the administrative supervision and technical supervision of drugs and pharmaceutical packaging materials, and formulate national standards for drugs and pharmaceutical packaging materials; Responsible for formulating quality management standards for the development, production, circulation and use of drugs and pharmaceutical packaging materials, and supervising their implementation.
The Drug Registration Department under the State Food and Drug Administration is specifically responsible for organizing the formulation of drug packaging materials and container product catalogs, medicinal requirements, standards and research guidelines; Undertake the registration of drugs, packaging materials and containers that come into direct contact with drugs, and pharmaceutical excipients.
The Ministry of Industry and Information Technology is responsible for formulating and organizing the implementation of industry plans, plans and industrial policies for the pharmaceutical industry, putting forward policy suggestions for optimizing the industrial layout and structure, drafting relevant laws and regulations, formulating rules, formulating industry technical specifications and standards and organizing their implementation, and guiding the quality management of the industry; And undertake the industry management of pharmaceuticals and pharmaceutical packaging materials.
China Pharmaceutical Packaging Association is a self-regulatory organization in the pharmaceutical packaging industry. The main responsibilities include organizing investigation and research on the market dynamics of drug packaging materials, containers, machinery and related pharmaceutical excipients, and transmitting market information in a timely manner; Organize and carry out cooperation and research on drug packaging technology, and promote new technologies, new materials, new processes, new equipment and consulting services related to drug packaging; Entrusted by the government to undertake or according to the needs of market and industry development, organize and hold national product introduction, trading and ordering exhibitions, and activate the market of pharmaceutical packaging materials, containers and packaging machinery; Publicize and implement national standards, participate in the formulation and revision of industry standards, and organize the formulation and release of association standards voluntarily implemented by the industry.
2. Industry supervision system
China implements a product registration and approval management system for pharmaceutical packaging materials, and the packaging materials and containers used by pharmaceutical manufacturers that are in direct contact with drugs must meet the requirements for medicinal use and the standards for protecting human health and safety, and be approved for registration by the drug regulatory department of the State Council. The State Food and Drug Administration formulates a catalogue of registered pharmaceutical packaging materials, and in conjunction with the drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government, implements examination and approval management for registration applications of pharmaceutical packaging materials in accordance with the principle of unified management and hierarchical responsibility, and implements a management model combining administrative supervision by government departments and self-discipline management of industry associations for approved pharmaceutical packaging material enterprises.
3. Industry-related policies
With the continuous improvement of China's laws and regulations, as well as the approval of the registration certificate of pharmaceutical packaging materials by the State Food and Drug Administration, the approval of the registration certificate of pharmaceutical packaging materials by the State Food and Drug Administration tends to be strict, and the pharmaceutical packaging industry continues to promote the development of the pharmaceutical packaging industry in the direction of standardization, such as: February 2024, The State Pharmacopoeia Commission issued two draft standards for pharmaceutical packaging materials, namely the guidelines for biological evaluation and test selection of pharmaceutical packaging materials and the guidelines for the tightness of sterile drug packaging systems, and the draft standards include the main text, drafting instructions, biological evaluation endpoints, analysis of the reasons for the abnormal end of biological experiments, selection of extraction conditions for biological experiments of pharmaceutical packaging materials, and 12 supporting test methods and drafting instructions.
Third, the development process
China's pharmaceutical metal packaging industry has experienced a long process from the initial stage to technological upgrading and then to innovation and development, with the continuous change of scientific and technological progress and market demand, in recent years, China's pharmaceutical metal packaging industry has entered a stage of innovation and development, and has continuously introduced new metal packaging materials, such as high barrier aluminum foil, environmentally friendly packaging, etc., to meet the diversified needs and environmental protection requirements of the pharmaceutical packaging market, in the future, with the further development of the pharmaceutical industry and the continuous change of market demand, China's pharmaceutical metal packaging industry will continue to usher in new development opportunities and challenges.
Fourth, industry barriers
1. Barriers to entry
The packaging materials and containers that come into direct contact with drugs directly affect the effectiveness and safety of drugs, and China has been subject to registration and approval management by the State Food and Drug Administration since 2004. Pharmaceutical packaging materials manufacturers must first carry out the transformation of the purification workshop, through the purification level testing of professional institutions by the Food and Drug Administration for on-site review, and select three batches of products for full inspection, all the tests are qualified and then organized by the China Institute for Food and Drug Control experts for technical review, and finally the State Food and Drug Administration for approval and issuance of the "Drug Packaging Materials and Containers Registration Certificate".
Each variety and each material structure of the direct contact drug packaging materials produced by the pharmaceutical packaging material manufacturer must obtain the "Registration Certificate for Pharmaceutical Packaging Materials and Containers" issued by the State Food and Drug Administration, especially since the implementation of the new version of GMP on March 1, 2011, the approval of the registration certificate for pharmaceutical packaging materials has become more stringent. The time period for newly established pharmaceutical packaging material manufacturers to obtain the qualification of "Registration Certificate for Pharmaceutical Packaging Materials and Containers" is long and difficult, and the acquisition of qualification forms an entry barrier for new entrants in the industry.
2. Technical barriers
Pharmaceutical packaging industry is a multidisciplinary, knowledge-intensive, capital-intensive high-tech industry, pharmaceutical packaging industry product development, design, production usually involves pharmacy, materials science, fine chemistry, packaging engineering, machinery manufacturing and other disciplines and technologies, into the pharmaceutical packaging industry needs to have a strong cross-industry technology integration ability, but also need to have a long-term technical experience accumulation, and the accumulation of proprietary technology and the cultivation of scientific research and development capabilities is a long-term process, Ordinary enterprises cannot be formed quickly in a short period of time. The industry-leading enterprises have a large number of pharmaceutical packaging material product registration certificates, pharmaceutical packaging material product technology patents, and leading product design, production technology and production technology, so the products they produce have significant advantages in variety, performance and customer satisfaction, which helps to maintain their core competitiveness and form barriers to enterprises that enter the pharmaceutical metal packaging industry later.
3. Financial barriers
Pharmaceutical packaging is a high capital investment industry, especially in the trend of more stringent requirements for the quality of pharmaceutical packaging materials, the need for new entrants in the industry to have strong financial strength as a guarantee: first, machinery and equipment and other fixed assets investment is larger, the purchase cost of key machinery and equipment is higher, if the production of high-performance products, may also need to be imported from abroad; Second, in order to meet the needs of different drugs, pharmaceutical packaging materials have always been in continuous development and innovation, and product R&D innovation and quality inspection need to spend more money.
4. Talent barriers
The pharmaceutical packaging industry involves a variety of disciplines and technologies, so having a group of high-level, multidisciplinary background compound professionals is the key factor to determine whether an enterprise has core competitiveness. Generally speaking, the growth cycle of core technical talents in the pharmaceutical packaging industry is long, and the cost of internal training is high. At the same time, enterprises have a greater degree of protection for this part of the talents, and often take various incentive measures to retain them, and it is difficult for new enterprises to enter the industry to attract the required technical personnel through open recruitment. The pharmaceutical packaging industry itself started late in China's market-oriented development, and universities and other training institutions lack advanced equipment, limited scientific research conditions, so it is difficult to train qualified high-end talents on a large scale in a short period of time. In addition to the core technical personnel, the pharmaceutical packaging industry has a large demand for skilled workers, and at this stage, the supply and demand gap of such talents in the mainland is large, and it is difficult for new entrants to recruit a sufficient number of skilled workers.
5. Channel barriers
The main reasons are: in order to meet the safety requirements of drugs, when pharmaceutical companies choose pharmaceutical packaging enterprises, they usually need to conduct on-site quality audits and retrospective analysis on a regular basis for pharmaceutical packaging materials manufacturers to investigate the compatibility of pharmaceutical packaging materials and drugs, which generally takes no less than half a year; If there is a change in the raw materials, prescriptions, and production processes of pharmaceutical packaging materials, pharmaceutical companies should re-verify their compatibility. Due to factors such as drug safety and compatibility verification time and cost, pharmaceutical companies generally do not easily replace existing qualified suppliers, thus forming channel barriers in the industry.
Fifth, the industrial chain
The upstream of the pharmaceutical metal packaging industry mainly includes metal materials (such as aluminum, tin, etc.), processing equipment, etc., among them, aluminum packaging is a commonly used pharmaceutical metal packaging material, because it is lightweight, recyclable, and has good barrier properties, which can prevent the impact of oxygen, moisture, etc. on drugs; Tin packaging is usually used for some pharmaceutical products that require higher preservative properties. The downstream of the pharmaceutical metal packaging industry is mainly oriented to the pharmaceutical market, and the end customers mainly include pharmaceutical companies such as chemical drugs, traditional Chinese medicine, and biological drugs.
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