Medical network - on January 13, 2016 on December 25, the 12th session of the standing committee of the National People's Congress 25 meeting through the act of traditional Chinese medicine. Promulgated the law, from brewing to eventually, after thirty years, is also China's first set for the traditional Chinese medicine the revitalization of the national law, the inheritance and development of traditional Chinese medicine is of great significance. Adjustment of the traditional Chinese medicine act include two aspects of traditional Chinese medicine and traditional Chinese medicine (TCM), and the production, circulation and use of traditional Chinese medicine (TCM) behavior and adjusting the current "drug administration law, how to do a good job of cohesion between the two laws? How to clarify the relevant legal issues? The author puts forward some thoughts on the following, for your friends to discuss.
Law applicable to the problem
The pharmaceutical administration law and the law of Chinese medicine in the same legal status, ZhuanMenFa series belongs to administrative law. From "drug" and "Chinese medicine" two independent specification object, two laws can be incorporated into the category of "special provisions". "Legislative law" the ninety-second regulation: "the same authority of law, administrative regulations, local decrees, autonomous decrees and special decrees, regulations, special regulations are inconsistent with the general provisions, special provisions shall be applicable, new regulations are inconsistent with the provisions of the old, the new provisions shall be applicable."
Since the "drug administration law and the law of traditional Chinese medicine all belong to" special provisions ", there is no priority between "general rules" and apply, can only be based on "the new rules are inconsistent with the provisions of the old, the new provisions shall be applicable to the" this principle. That is to say, if the "drug administration law and the law of traditional Chinese medicine is not consistent, shall be in accordance with the applicable method of traditional Chinese medicine.
The traditional Chinese medicine act article 60 points out: "the management of traditional Chinese medicine, if there are no relevant provisions in this law, apply professional medical practitioners law of the People's Republic of China, the pharmaceutical administration law of the People's Republic of China and other relevant laws and administrative regulations." , which embodies the principle of the applicable law.
Law enforcement main body problem
Considering the object of the same specification, traditional Chinese medicine (TCM), two laws and the method of traditional Chinese medicine is "new rules", mean that the administrative law enforcement main body associated with traditional Chinese medicine (TCM) will change?
For this problem, related laws have give clear answer. "Law on administrative punishments" article 15 of the regulation: "administrative penalties by an administrative organ has a administrative punishment implemented within the scope of their statutory functions and powers." Here to emphasize the statutory functions and powers. If the act of traditional Chinese medicine is not the original administrative institutions and relevant regulatory functions to adjust Chinese medicine, also means that the current system of law enforcement does not change, the law enforcement main body still maintain existing models.
Stipulated in article v of the "method of traditional Chinese medicine", "the state council departments responsible for the management of the national Chinese medicine of traditional Chinese medicine. Within the scope of their respective responsibilities of other relevant departments under the state council in charge of work related to the management of traditional Chinese medicine." "Local people's governments at or above the county level departments in charge of traditional Chinese medicine Chinese medicine management work in their respective administrative areas. Local people's governments at or above the county level within the scope of their respective responsibilities to other departments in charge of work related to the management of traditional Chinese medicine." The system did not make an adjustment on management of traditional Chinese medicine.
Article 56 the TCM act is involved with drug safety law enforcement related legal liability clause, including the traditional Chinese medicine clinics, concocted Chinese medicine yinpian, entrust the preparation of TCM should be put on record and did not put on record, or for the record to provide false materials when the punishment of the illegal act, a clear "by the competent department of traditional Chinese medicine and the pharmaceutical supervisory and administrative departments shall, according to the division of their duties shall be ordered to correct,...". According to the rules, is obviously under the current system of law enforcement.
Method of traditional Chinese medicine as prescribed in paragraph 2 of article 56: "the application of traditional process preparation traditional Chinese medicine preparations of medical institutions is not in accordance with the provisions of this law for the record, or not in accordance with the requirements of the record filing materials indicate the compound preparation of traditional Chinese medicine, penalties shall be imposed according to the production of fake drugs." This is no suffix that law enforcement main body, but in fact is in violation of the clause of article 32 of the act of traditional Chinese medicine. Stipulated in article 32 of the traditional Chinese medicine act: "only the application of traditional process preparation of TCM varieties, to the local people's governments of provinces, autonomous regions and municipalities directly under the central government medical institutions can be made after the pharmaceutical supervisory and administrative departments for the record, do not need to get the document of approval for preparation." The agency, the legal duty of supervision and authority of law enforcement shall be investigated for legal responsibility of the subject nature don't need to explain.
The ancient classic square problem
Article 30 of the act of traditional Chinese medicine is put forward that the production meets the conditions prescribed by the state from ancient classic square compound preparations of Chinese medicine, when applying for drug approval number, can only provide non-clinical safety study materials. Shall be formulated by the pharmaceutical supervisory and administrative department under the state council together with the competent department of traditional Chinese medicine.
The so-called ancient classic square, is still widely used, curative effect, has obvious characteristic and advantages of classics written in ancient Chinese medicine prescriptions. The specific catalogue shall be formulated jointly by the competent department of traditional Chinese medicine pharmaceutical supervisory and administrative department under the state council.
This content with the current drug registration management rules are not consistent. ZhongYaoJie to concentrate on the rules. Many people think that this may be out of the dilemma of examination and approval of TCM and a big opportunity.
The author believes that the implementation of the rules, there is a long way to go. Two departments work together is very important, related technical problems of cracking is no easy ride.
What is the "ancient"? What is a "classic"? What could be called "square"? Medicine itself in these problems, it is difficult to achieve consensus, and also involves the coordination between the two departments under the state council. As a result, the industry can open debate this issue, but related regulations eventually fall to the ground, also need to all aspects of the continuous efforts. More appropriate approach is to organize experts to select "ancient classic square", mature and a batch of, released a batch. Seek a directory include everything, is almost impossible. But so, too, to promote the cause of traditional Chinese medicine to speed up the development.
Traditional Chinese medicine yinpian processing process problems
The provisions of article 27 of the "method of traditional Chinese medicine", "national protection of traditional Chinese medicine yinpian processing technology and techniques, and support the application of traditional craft processing Chinese medicine yinpian, encourages the use of modern science and technology to develop Chinese medicine yinpian processing technology research."
The above regulations is not consistent with the pharmaceutical administration law expression. Stipulated in article 10 of the drug administration law, "Chinese medicine yinpian must, in accordance with the national drug standards; in the absence of provisions in the national drug standard, must according to the people's governments of provinces, autonomous regions and municipalities directly under the central government promulgated by the pharmaceutical supervisory and administrative department of process for processing."
It involves the problem of the traditional craft TCM firing. Many traditional Chinese medicine processing technology is not consistent with existing national drug standards. As a commonly used Chinese medicine rhizoma polygonati, as according to the ancient "nine steam nine sun" method for processing, and has a big change, regardless of sexual flavour its according to pharmacopoeia detection of rhizoma polygonati polysaccharide content cannot reach standard. And like a jade bamboo, Chinese traditional medicine according to pharmacopoeia requirements, only need to remove impurities, wash and stuffy embellish to thoroughly, cut thick slices, dry, but the traditional process has scraped honey water steaming, steamed, baked, etc.
The crux of the problem is that if the traditional craft and modern process, will not be able to according to the standard for inspection or unqualified phenomenon, Chinese medicine yinpian production enterprises, circulation enterprises and medical organizations are likely to illegal risks. Despite the support of traditional processing technology in the applicable law, but in the absence of relevant laws and regulations, if you don't press for preparing drug unit, many law enforcement problems will be difficult to resolve. Therefore, it is recommended that the relevant departments of the traditional processing technology research, can according to different varieties, after the traditional craft into the "specification", which issued by the food and drug regulatory authorities, if necessary, otherwise could brew yinpian processing aspects of the mess.
Traditional process preparation traditional Chinese medicine (TCM) preparations
Stipulated in article 32 of the traditional Chinese medicine act, the medical institutions only application of traditional process preparation of TCM varieties, to the local people's governments of provinces, autonomous regions and municipalities directly under the central government can be made after the pharmaceutical supervisory and administrative departments for the record, do not need to get the document of approval for preparation.
Also pursuant to the current request the pharmaceutical administration law. For many years, the drug regulatory agency of strengthening the management of medical institutions and drug preparations, both hardware and software requirements, have been improved. Set the number of pharmaceutical preparation of medical institution and varieties of overall showed a trend of decrease, declare new varieties of traditional Chinese medicine hospital preparations approved more difficult.
"Method of traditional Chinese medicine" of the new rules, in the concrete implementation process may encounter problems include: the definition and criterion of process management of traditional craft; Quality standards; Quality control; The examination; The control of quality of raw materials; How to ensure preparation unit not borrow traditional process in the name of the reality of the modern technology... . And so on.
The author thinks that, the problem of compound preparation of traditional technology, also need to state two departments on the basis of investigation and research, a related "detailed rules". Should listen to the views of all levels, various aspects widely, can be in a leading medical institutions pilot, implemented step by step after gaining experience again.
The act of traditional Chinese medicine also demanded that a medical institution shall strengthen the variety of adverse reaction of TCM and monitoring for the record, and report in accordance with the relevant provisions of the state. Pharmaceutical supervisory and administrative departments shall strengthen the varieties of traditional Chinese medicine preparation for filing preparation and use of supervision and inspection. The principle regulation, need through the establishment of a series of form a complete set of regulatory rules to guarantee. |
