According to the existing Provisions for Drug Registration (SFDA Order No. 28), applications for new drugs of traditional Chinese medicine are divided into two parts: the applications for drug clinical trial and for drug production (including new drug certificate). It will last for about 10 years from the application for drug clinical trial to get approving, and it also remains many problems and the low probability to succeed. From the sight of pharmaceutical review, there are mainly two aspects of regulatory compliance and technical issues, mainly for changes without approval of the competent authorities of the country. For example, sample preparation and approval of clinical trial process are significant changes. Technical problems are reporting incomplete data or information submitted does not comply with the technical requirements for review, such as: production process validation does not provide information, the preparation of samples for clinical trials and field inspection, production information, or the information provided does not meet the technical requirements. This paper summarizes the frequently asked questions and to make recommendations to advise applicants concerned, timely detection of problems, avoid risk, improving the quality and efficiency of the application for registration.
China ; Drug Approval ; legislation & jurisprudence ; Drug Evaluation ; legislation & jurisprudence ; Humans ; Legislation, Drug ; Medicine, Chinese Traditional

The rationality of current validity period of the preparations in medical institutions was analyzed. Based on the discussion of the main functions of the validity period in administration admission and the essential principles for the reasonable enactment of the validity period, author suggested that the validity period should be amended as 5 years in order to exert more effectively on administration admission of the preparation of medical institution.
China ; Drug and Narcotic Control ; legislation & jurisprudence ; Health Facilities ; legislation & jurisprudence ; standards

This article discusses the characteristics of cmmunity herbal monographs for traditional herbal medicinal products and its establishment procedure. It also reviews the new development of cmmunity traditional herbal monographs. The purpose is to clarify the relationship between cmmunity herbal monographs and simplified registration for traditional herbal medicinal product in European Union and provide reference to the registration of taditional Chinese mdicinal products in Europe.
Drug Approval ; legislation & jurisprudence ; European Union ; Humans ; Phytotherapy ; Plants, Medicinal

In recent years, emerging technology medical devices have developed rapidly. How to more scientifically and more efficiently regulate these novel medical devices so as to improve access to advanced medical technology while ensuring safety and effectiveness is a new challenge faced by regulatory authorities, and is also the core topic of regulatory science. New tools, new standards and new methods are important means to achieve regulatory science. "Medical Device Development Tool" proposed by the U.S. FDA is a novel medical device regulatory science tool, which can help medical device developers to predict and evaluate product performance more efficiently. It is also helpful for regulatory authorities to make regulatory decisions more efficiently. This study introduces the concept, qualification process, role of MDDT in medical device regulation and MDDT examples, and makes some discussion on the device evaluation from the perspective of reliability and validity. MDDT can facilitate the developing of novel medical device.
United States ; Medical Device Legislation ; Reproducibility of Results ; United States Food and Drug Administration ; Technology ; Device Approval

The article briefly introduces the status of the supervision and administration of Chinese herbal medicine, and summarizes the problems existing in the process of supervision and management. Meanwhile provides the countermeasures and suggestions of strengthening the supervision and administration of Chinese herbal medicine.
China ; Drug Contamination ; legislation & jurisprudence ; prevention & control ; Drug and Narcotic Control ; Drugs, Chinese Herbal ; chemistry ; standards ; Medicine, Chinese Traditional ; standards ; Quality Control

No abstract available.
Korea* ; Legislation, Drug*

Through collecting and collating the development process of traditional Chinese medicine dispensing, the development of modern Chinese medicine dispensing on the basis of experience could be promoted. "Heyaofenji", "Hehe", " Heji" in ancient Chinese medicine, herbal medicine literature and law were collected, and then things were sorted out according to traditional Chinese medicine dispensing theory, skills and legal norms. Firstly, "Tang Ye Jing Fa" is the earliest book which marks the rudiment of traditional Chinese medicine dispensing. Secondly, traditional Chinese medicine dispensing theory formed in "Shen Nong's herbal classic". Thirdly, Zhang Zhongjing's "Treatise on Febrile Diseases" marked the formation of Chinese medicine dispensing skills. Lastly, Provisions in Tang Dynasty law marks the development of traditional Chinese medicine dispensing.
Chemistry, Pharmaceutical ; education ; history ; legislation & jurisprudence ; methods ; China ; Dosage Forms ; Drug Compounding ; history ; methods ; Drug and Narcotic Control ; history ; legislation & jurisprudence ; Drugs, Chinese Herbal ; chemistry ; History, Ancient ; Medicine in Literature ; Medicine, Chinese Traditional ; history ; methods

OBJECTIVETo provide references for the evolvement of medical devices labeling and manual administration in China,

METHODSBy content analysis, 10 juristic documents relevant to device labeling and manual were collected from FDA website, compared to which, the federal regulation was mainly analyzed.

RESULTSThere are five main differences of device labeling regulation between U.S.A. and China: juristic system, administrative scope, administrative target, characteristics and practice,

CONCLUSIONSA set of comprehensive juristic system for device labeling has been established by FDA. from which China should draw experience, to administrate the prescription devices and the over-the-counter devices in classification, and set up device labeling guidance, thus guarantee the safety and efficacy of device.

Adolescent ; Adult ; Drug and Narcotic Control ; trends ; Humans ; Male ; Paranoid Disorders ; etiology ; Plant Poisoning ; prevention & control ; psychology ; Product Packaging ; legislation & jurisprudence ; trends ; Psychotropic Drugs ; pharmacology ; Salvia ; adverse effects ; chemistry ; Street Drugs ; adverse effects ; legislation & jurisprudence

Risk monitoring of new Chinese patent anti-hepatoma drugs is tracking recognized risks and residual risks, identifying emerging risk and ensure the implementation of the plan, estimating the process of reducing effectiveness. The paper is mainly through understanding the status of Chinese patent anti-hepatoma drugs, the content, characteristic and analysis method of dynamic risk monitoring, and then select the risk control indicators, collect risk information. Finally, puts forward the thought of anti-hepatoma drugs listed evaluation in our country, and try to establish the model of dynamic risk management of anti-hepatoma drugs.
Antineoplastic Agents, Phytogenic ; adverse effects ; economics ; therapeutic use ; Carcinoma, Hepatocellular ; drug therapy ; Drug Discovery ; economics ; legislation & jurisprudence ; organization & administration ; Drug and Narcotic Control ; economics ; legislation & jurisprudence ; organization & administration ; Drugs, Chinese Herbal ; adverse effects ; economics ; therapeutic use ; Humans ; Liver Neoplasms ; drug therapy ; Product Surveillance, Postmarketing