The hottest survey of pharmaceutical packaging and

2022-08-15
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Overview of pharmaceutical packaging and international standards

China's pharmaceutical packaging and international standards China's "Drug Administration Law" has a special chapter on "packaging and sub packaging of drugs", which makes special provisions on drug packaging. It includes: the name, specification, manufacturer, approval number, batch number, main ingredients, indications, usage, dosage, contraindications, adverse reactions and precautions of the drug must be indicated on the label or instruction of the drug package. The measures for the administration of materials and containers for drug packaging (Provisional) and the provisions on the administration of drug packaging labels and instructions promulgated in 2000, and the measures for the administration of packaging materials and containers in direct contact with drugs adopted and promulgated on June 18, 2004, have made detailed provisions on drug packaging. Traditional Chinese medicine in China has a history of thousands of years, but it has not entered the European and American markets on a large scale. In addition to the outdated production technology and some prejudice of European and American countries on traditional Chinese medicine, the failure of drug packaging to implement international standards is also an important reason. The packaging of traditional Chinese medicine for export must comply with the relevant laws and regulations of the importing countries and regions. For example, Singapore lists Coptis chinensis and Ligusticum chuanxiong as toxic substances, and the import of traditional Chinese medicine containing these ingredients is prohibited. For traditional Chinese medicine containing lead and aluminum, the lead content must be less than 15ppm, and the aluminum content must be less than 20ppm; The United States also prohibits the import and sale of traditional Chinese medicine related to heavy metals such as cinnabar, mercury and arsenic. It is understood that in order to strengthen the 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. It is stipulated 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, that is, a drug identification number management license. In addition, the U.S. Department of Agriculture recently 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 incoming goods will be refused entry. France has stricter regulations on wood packaging, which stipulates that all imported products are not allowed to use wood packaging. The U.S. Food and Drug Administration (FDA) has formulated corresponding regulations for all links of drug sales, and stipulated that all drug-related materials should be subject to clinical scientific testing. The content of drug labels must not only include the use of drugs, precautions for special groups (such as children, pregnant women, etc.), dosage instructions, use methods and time, but also indicate the side effects, contraindications and efficacy of drugs. Any label that does not meet the requirements of the regulations is recognized as a "false label", which is a serious violation of federal law. In order to advertise drugs or provide relevant promotional materials, the content must be exactly the same as our preferred content in the future, and there must be no other materials without approval or beyond the scope of the label. Obviously, the implementation of these regulations has had a certain impact on the sales of Chinese traditional medicine in the North American market. Environmental protection has gradually become a new international standard. Developing green packaging, protecting the environment and promoting the sustainable development of society are hot issues of global concern. After China's accession to the WTO, tariff barriers are gradually eliminated, but technical barriers and environmental barriers are gradually forming. In January, 1999, is asked to re tension the tensioning wheel; O's green environmental protection sign (EL) has been implemented worldwide. Now many countries in the world are restricting excessive packaging and introducing many corresponding regulations. For example, the UK limits the complexity and luxury of commodity packaging in accordance with a certain proportion, and severely punishes those who exceed the standard, so as to encourage businesses to simplify packaging for the benefit of environmental protection. In China, a "green packaging law" should also be introduced, which should include the treatment of drug packaging waste, the safety of packaging materials and the regulation of human health protection. Market economy is legal economy. While designing the packaging of China's pharmaceutical products, we should also pay attention to its unavoidable legal problem of automatic shutdown, so that it can comply with the rules of the game, which is beneficial to promoting the healthy development of China's pharmaceutical packaging industry and even the pharmaceutical industry, enhancing its international competitiveness and its ability to resist risks. Reprinted from: Guangdong packaging

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