winter flu multiple, Beijing chaoyang district lee appeared the symptoms of headache, stuffy nose, runny nose, cough, to the pharmacy to buy a box of even take antipyretic granules, carefully read the instructions: & other; Specifications & throughout; For each bag 6 g; & other; Usage and dosage & throughout; As an oral, 1 bag at a time, three times a day. Although how to use said very clearly, how much but with drugs, will have side effects make people confused. The drug indicate the honeysuckle, rhodiola, etc more than ten kinds of main ingredients, but per gram dose not indicate. At the same time, the instruction of & other; Adverse reactions throughout the &; & other; Taboo & throughout; Are & other; It is not clear & throughout; , only & other; Notice & throughout; Indicate the athletes with caution. After Ms. Li look very confused, athletes can’t use, that pregnant women can use?
Chinese medicine specification information is not standard, the problem of incomplete is common. State food and drug supervision and management of administration has issued the proprietary Chinese medicine specifications describe technical guidelines “(hereinafter referred to as the” principles “), will help in traditional instruction standardization? To make more clear, more assured for treating patients?
convenient use, instruction should be dynamic revision & other; Traditional Chinese medicine yinpian made certain dosage forms, no decoction, convenience for the patients. A lot of proprietary Chinese medicines are prescription drugs (OTC), patients can go and buy directly use. But a look at the traditional Chinese medicine instruction palm-sized, a few hundred words, some involving the drug safety under written & lsquo; It is not clear & rsquo; & lsquo; An unknown & rsquo; . Such instruction is not only inconvenient in patients with drug use, also brings to the drug safety hidden trouble. At the same time, the pharmacist to guide patients with drug use, need to examine relevant documents and technical standards to can clear these drugs for pregnant women, children, the elderly and other special groups. Throughout the &; Hospital pharmacy professional committee of China medicine institute drug safety team, Peking University third hospital pharmacy department, deputy director of the original xiao-le zhang said.
& other; Regulatory policy is based on the artificial core, in order to ensure the safety of drugs of the people. The specification proprietary Chinese medicine specifications, doctors and patients in order to become the be clear at a glance. Throughout the &; Food drug safety administration of the relevant person in charge of registration management said drug cosmetics.
like some proprietary Chinese medicine specifications and usage and dosage correlation is not strong. A document number specification label for every bottle of 60 g, and dosage for every 20 grains, doctors or patients don’t know how much every 20 grain weight, including how many slices; If specification label to each grain is equivalent to 0.15 g slices, doctors or patients medication is more clear.
again, for example, part of the pharmaceutical standards of prescription for the compound, but the specification of single herb composition content, only specification marked not comprehensive easy to misleading. Such as compound berberine tablets (sugar pill) composed of berberine hydrochloride, combination, evodia rutaecarpa, radix paeoniae alba, etc, but specifications marked only illustrates the 30 mg per piece with berberine hydrochloride, no labeled other slices dosage in the compound, core elements is not sufficient.
of course, the traditional description of the problem is not a specification, & other; Adverse reactions throughout the &; & other; Taboo & throughout; & other; Notice & throughout; Missing, there is a hidden danger. It is understood that there are physicians in the use of a proprietary Chinese medicine, because there is no any instruction composition and content of the label, no warning, the results of a drug overdose cause harm to patients.
food drug safety administration of drug registration management relevant controller introduces cosmetics, many products have been listed for many years, if in the post-marketing surveillance to adverse reactions, all must modify the manual. Drug marketing authorisation holder system is established, and drug marketing authorisation holder for the drug safety, efficacy and quality controllable liable subject. National adverse drug reaction monitoring center each year will also be related to the enterprise by feedback, revision of the instructions should be dynamic.
encourage voluntary, not in the short term & other; One size fits all & throughout;
Shanghai university of traditional Chinese medicine group of 60194 Chinese medicine preparation of the specifications of the description and the statistics, nearly 90% of the traditional Chinese medicine (TCM) approval document in the instruction manual & other Specifications & throughout; Under no sign of single dose drug dosage, but to weight and charge to mark specifications. Even take antipyretic particles, for example, on the basis of the principle, the specifications should be presented as & other; Slices per 1 g & times; & times; G” .
there are media interpreted as “principle” at least 90% of the proprietary Chinese medicine must modify specifications, give a person with & other; One size fits all & throughout; Feeling. The relevant person in charge of this food drug safety administration of medicine cosmetics registration management said: & other; Like the flower, antipyretic granules manual specification statement does need to improve in the future, but regulators consider the enterprise cost, at present not mandatory rules, encourage enterprises according to their own situation in a planned way, the specification. Companies don’t have to worry about the current product sales, under the guidance of the public pharmacists in medication use is also to ensure safety. Throughout the &;
and promulgated before the traditional general name technical guiding principles set up two different years, promulgated the “principles” is not a compulsory execution schedule. Main encourage companies to voluntarily specification, not in the short term & other; One size fits all & throughout; . But he wouldn’t consciously specification, if the company a few years down by the marketing authorisation holder responsibility regulators will be implemented, drug registration measures such as forming reversed transmission situation again.
& other; Specification proprietary Chinese medicine specifications of the technical standard is a good, shows that regulators attaches great importance to the specification and standardization of Chinese medicine, Chinese medicines, actively promote the management to the direction of scientific and standardized. Traditional Chinese medicine and western medicine (medicine), there are always two sides to everything, save people’s lives or at the same time also has its adverse reactions, requirements from the perspective of scientific norms of proprietary Chinese medicine instructions, the standard should not be lower than western medicine. Throughout the &; Xiao-le zhang said.
based on long-term, standardized reversed transmission enterprise development
traditional Chinese medicine (TCM) is a national treasure, and relationship between common people’s life and health problems, regulators issued relevant policy nature is a major concern. Recent regulatory departments for relevant policies with the accelerating pace of proprietary Chinese medicine field. Combing regulatory policy will find a keyword in the field of proprietary Chinese medicine & ndash; & ndash; Standardization.
standardization will be reversed transmission with high quality Chinese traditional medicine development. Standardization of TCM industry pipe shall not be put to death, but in order to make better industry development. Standardization is to ensure the quality of products in the production of TCM modernization.
& other; Proprietary Chinese medicine production enterprises should also take responsibility, specification this step is also relatively easy to have, to & lsquo; Adverse reactions & rsquo; & lsquo; Taboo & rsquo; & lsquo; Notice & rsquo; Projects such as the supplement has a lot of work to do. Some proprietary Chinese medicine sales in the market for many years, companies have a responsibility to the adverse reaction was observed, and try to get first-hand research improve the instruction, to make their products more long-term development. Throughout the &; Xiao-le zhang told reporters.
standardization will help Chinese medicine to world. In recent years, gradually by the international recognition of Chinese medicine, especially our country scientists developed the Chinese medicine artemisinin influenced the won the Nobel Prize in physiology or medicine. Chinese medicine products, when you go to the international, domestic first to practice internal work, on the basis of respect for traditional Chinese medicine characteristics must adhere to comply with the attributes of the drug management ideas, to make the Chinese medicine to do bigger and stronger, stable curative effect has been widely accepted, and even lead the international standard. & other; Only is like the western medicine on proprietary Chinese medicine, strict with the standard specification, and traditional Chinese medicine to carry forward, towards the world. Throughout the &; Xiao-le zhang said.
the relevant person in charge of food drug safety administration of medicine cosmetics registration management said: at present, accord with the characteristics of traditional Chinese medicine registration management system has been constructed, but still need to improve. In the future, more standardized, more convenient physicians and the public use of proprietary Chinese medicine will be more and more.