A probe into the hottest overseas drug packaging m

A probe into the overseas pharmaceutical packaging market

the huge scale of the global pharmaceutical market provides a broad market space for the development of the supporting pharmaceutical packaging industry. According to a research report of the American Freedonia consulting company, the global pharmaceutical packaging market demand will grow at an average annual rate of 6.3% in the next few years, and the market size will increase from US $22.3 billion in previous years to US $30.2 billion in 2009. Among them, the fastest growing demand of pharmaceutical packaging market is syringe and syringe packaging, but plastic bottles will still occupy the largest share of pharmaceutical packaging market demand. The consulting company predicts that the demand for pharmaceutical packaging in the North American market will grow at an average annual rate of 7.3%, and the market size will reach US $11billion by 2009; The growth rate in the Asia Pacific region will reach an average annual rate of 7.7%, and the market size will reach US $8billion by 2009; The growth rate of market demand in Western Europe is relatively slow, with an average annual growth rate of 4.2%. By 2009, the market scale will be $8.4 billion

in view of such a market scale, experts believe that after China's accession to the WTO, domestic pharmaceutical enterprises will inevitably participate in the competition in the international market. In order to eliminate the technical barriers caused by pharmaceutical packaging and other reasons, it will need advanced packaging equipment and materials that meet international standards to cooperate with its development, which also puts forward higher requirements and broader market space for domestic pharmaceutical packaging enterprises. Drawing on relevant foreign drug packaging regulations and information, China's pharmaceutical packaging should consider the following from the perspective of enterprises themselves: the packaging of drugs should be more concise, clear and beautiful; On the premise of ensuring that it is not easy to be damaged during transportation, try to save materials and avoid excessive packaging; Improve the market competitiveness of enterprises by constantly improving the quality of employees. The national macro-control department should also speed up the legislative work of packaging, raise the technical threshold, and constantly guide the benign development of enterprises through macro-control

full exposure in overseas drug packaging market

1 drug side effects must be packaged

the U.S. Food and Drug Administration (FDA) recently announced that in the future, the packaging of over-the-counter painkillers should use obvious fonts and frames to highlight their side effects, so as to remind patients to use them correctly. Although the number of deaths due to side effects of painkillers accounts for only a small proportion of all users, the number of physical injuries caused by them is increasing. The new regulations require that the side-effect warning of over-the-counter painkillers must use a standard format, such as the bold display of acetaminophen's easy damage and inherent renewable characteristics of the liver; Aspirin, naproxen, ibuprofen, etc. are easy to cause gastric bleeding, and they are placed at the front of the "warning" section. In addition, the category of drugs, such as "acetaminophen" or "non steroidal anti-inflammatory drugs", should be marked at the obvious position of the outer package and inner package of relevant OTC drugs, and its font size should be at least the same as that of the drug name

2 the US medical packaging regulations

drug packaging regulations require that medical products be certified before they are put on the market, that is, manufacturers must provide FDA with sufficient evidence to show that the drug is safe and effective before producing and selling a drug, and establish archives. Of course, the packaging of their products is also one of the testing items. For example, the products must be pasted with the shelf life and stability test results to ensure that the drugs have no toxic and side effects within the shelf life. The stability test requires that "the detection of drugs should be carried out in the actual packaging of drugs" (21cfr211.166) (Note: according to CFR nomenclature, 21cfr211.166 means: CFR section 211, paragraph 21, section 166.)

in the process of formulating the regulations, the food and Drug Administration (FDA) and the United States Pharmacopoeia (USP) will work closely together, because U.S. law stipulates that any sold drugs listed in the USP must comply with USP standards. In the testing of packaging materials, most of them need to meet the relevant testing standards of ASTM and ISO, and provide testing reports

after the drug is put on the market, if the manufacturer requires to change the "packaging" and "packaging materials" in any way, the stability test of the drug must be carried out in the new packaging, and a supplementary instruction of the new drug application (NDA) must be provided to FDA. The new packaging can be put into use only after it is approved. There are also relevant provisions for accelerated testing under high temperature and high humidity conditions

the accelerated test is carried out under harsh conditions, accelerating some slow changes that may occur under normal storage conditions. However, even if a new drug is licensed on the basis of accelerated test results, it still needs stability test evidence within the shelf life under normal storage conditions. Therefore, changing drug packaging is a very difficult and complex work. For this reason, many pharmaceutical manufacturers in the United States attach great importance to the quality of products and packaging, and have done a lot of work and experiments in the early stage of launch. Establish a special laboratory to enter 4. Change the experimental machine to detect drugs and packaging

FDA also allows some packages to be replaced with plastic resins. Generally, the same "closed container system" test does not only refer to the same kind of plastic, but also the same kind of container including plastic formula. Therefore, FDA adopted the procedure set by USP, allowing manufacturers to change packaging before obtaining FDA approval. If the test of approved materials shows that the new plastic varieties selected are the same, the test draft can be used as the basis for judgment. At present, only HDPE, LDPE, pet and propylene glycol modified PET and other materials have such a test draft. For example, if two kinds of HDPE bottles meet the requirements of the test draft, they can be interchanged, that is, if one of them has been proved to be safe for a specific occasion, the other can also be applied to this occasion. However, the packaging materials can only be interchanged after the stability test proves to be safe

Chinese enterprises need to do a lot of preliminary work to sell drugs in the United States. First, they need to find partners in the United States and establish files in FDA. Only after FDA approval can it be sold in the United States. But at present, the biggest problem encountered by Chinese drugs before entering the market is the inspection of "packaging materials". Many materials that can meet national standards at home have encountered layers of resistance abroad

3 management of Chinese herbal medicine and its products

Health Canada has formulated a series of regulations such as the food and drug safety management act and the drug identification number management act to strengthen the management of Chinese herbal medicine and its products, which stipulate that any product with therapeutic effect should be treated as a drug, and products that do not meet the health standards are not allowed to be listed. All Chinese herbal medicine products must apply for a drug license from Health Canada, Drug identification number management license. In addition, the U.S. Department of agriculture has also made new regulations on the packaging of all imported products, including Chinese herbal medicine. All pure wood packaging materials must be treated with high-temperature fumigation or protective agents, otherwise all transported goods will be refused entry. France has stricter regulations on wood packaging, stipulating that all imported products are not allowed to use wood packaging

4 new EU regulations on drug packaging: the new EU regulation 2004/27ec (the amended version of the regulation 2001/83/ec) for human drugs, which marks the product name in Braille, came into force on April 31, 2004. This regulation requires that the product name of the drug should be marked on its package in Braille. Since October 30, 2005, this provision has gradually become a national regulation of Member States. The specific time of entry into force varies according to the actual situation of different countries

the product name of all pharmaceutical products for human use should be marked in Braille. Braille is an international reading and writing system designed for blind and amblyopic groups. This system was founded by Louis Breuer (1809~1852), a blind man who lived in France. Adding Braille to folding cardboard is not a difficult technical process, but it poses a challenge to processors

the European Association for the blind has described the characteristics of Braille as follows:

the height of the bump (ideal):0.5 mm; Diameter of the bottom end of the bump: 1.3 mm; Horizontal distance between two points in Braille unit: 2.5 mm; Longitudinal distance between two points in Braille unit: 2.5 mm; Distance between Braille units (between each group of points):6.0 mm; Distance between blind text lines (between each group of points):10.1 mm

5 the problem of counterfeit drugs is serious, and the prevention and treatment of counterfeit drugs in pharmaceutical packaging has become a priority.

the spokesman of the World Health Organization announced in Geneva that 10% of the drugs sold worldwide are counterfeit drugs, and the annual sales of counterfeit drugs reached us $32billion. Similarly, due to the further opening of the drug market and the fact that purchasing drugs has become a fashion, the problem of fake drugs may also be serious, which may solve some of the problems that caused this weather, which have plagued the European pharmaceutical market. The prevention and treatment of counterfeit goods has become the top priority to protect the health and safety of consumers. Drug packaging anti-counterfeiting has become an important and indispensable part of drugs. Like the development of medicine, the anti-counterfeiting of pharmaceutical packaging is also impacted by counterfeit products

European pharmaceutical packaging manufacturers design and produce a large number of new generation anti-counterfeit packaging. German Tess company has nearly 10 kinds of anti-counterfeiting marks on a kind of medicine box less than palm size. It uses miniature characters, glazing and plate making, and adopts anti-counterfeiting marks that can be recognized by the naked eye, such as banknote gravure printing technology, and anti-counterfeiting marks that can be seen only with special lenses. Not only that, the company also printed anti-counterfeiting logos that only a few people know, and constantly developed and updated anti-counterfeiting logos. In addition, the company often sends special personnel to pretend to be customers to conduct spot checks on the market

in Europe, once fake drugs appear in prescriptions, pharmaceutical manufacturers and drug packaging suppliers will bear corresponding and obligations respectively. If the patient is injured due to taking fake drugs, the pharmaceutical factory must show its anti-counterfeiting Certificate in court. If the pharmaceutical factory has not done or done little in this regard, it can be defined as "weak organization", and it must undertake its due obligations. If the pharmaceutical factory has done all its strength in technology, it can be exempted from punishment. The packaging supplier proved the authenticity of the kit when a lawsuit occurred. For this reason, suppliers have introduced very special identification technology in the production process, and only a few people know these identifications, and some even pharmaceutical companies do not know them. Only in this way can we ensure to prove the authenticity of drug packaging in court, maintain the reputation of enterprises and protect the health and safety of consumers

6 European pharmaceutical packaging

it is estimated that the annual sales of pharmaceutical packaging materials in the whole Europe (including Eastern Europe) reached US $3.246 billion. The main packaging forms are containers and cartons, each accounting for 1/4 of the total sales; The second is blister packaging (including PVC strips and small bags), accounting for about 22%; The rest is occupied by bottle seals, labels and other types of drug delivery systems. In terms of materials, paper and paperboard sales accounted for 37%, plastic sales accounted for 28%, metal sales accounted for 26%, and glass sales accounted for only 9%

in 2007, the sales of packaging materials is expected to grow in parallel with the sales of drugs, and the negative effects of reducing the packaging weight will be balanced by the trend of high-value packaging. In fact, the sales of packaging may grow faster than the sales of drugs, although the range will not be too large. This is because pharmaceutical companies are willing to buy at a higher price, which is safer, vandal proof, child proof, convenient for the elderly and can ensure