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

This paper studies the necessity of the current legislation on the supervision of medical devices in China from the perspectives of strengthening administration according to law, protecting public health, perfecting the legal system of medicine and promoting the development of the medical device industry. This study analyzes and summarizes the legislative experiences and forms in the field of medical device regulation in the United States, the European Union, Japan and other countries and regions, at present, the conditions of carrying out the legislation of medical device supervision in China are quite mature, and some policy suggestions are put forward for the enactment of the law of medical device management in China.
Equipment and Supplies ; European Union ; Feasibility Studies ; Industry ; Medical Device Legislation ; United States ; United States Food and Drug Administration

Veregen™ and Fulyzaq are the first two botanical drug products that were approved by the Food and Drug Administration (FDA) to market in the US in recent years. Additional herbal medicines, including Compound Danshen Dripping Pills, Fuzheng Huayu Tablets, Xuezhikang Capsule, Guizhi Fuling Capsule, Kanglaite Capsule and Kanglaite Injection, have filed the investigational new drug (IND) application to the FDA and are in phase II or phase III clinical development. In order to gain better understanding of the process of botanical drug approval in the US, this article examines the aforementioned drugs by looking at their composition, indication, prior clinical experience and clinical development process, and summarizes key features that enabled IND filing and marketing approval by the FDA.
China ; Drug Approval ; legislation & jurisprudence ; Drugs, Chinese Herbal ; therapeutic use ; Humans ; Nonprescription Drugs ; therapeutic use ; United States ; United States Food and Drug Administration

To assure the effective operation of certification and accreditation in the laboratory management system, further strengthen the instruments and equipment management, and provide specific recommendations on improvement of internal audit, management review and continuous improvement of management system. The inspector program had been firstly established and complemented. Through the inspection, we identified many deficiencies, made many specific recommendations for improvement. After inspection, the working procedures were improved; data from department were more rigorous, scientific and just; hardware foundation was established for international mutual recognition.
Accreditation ; Food Inspection ; legislation & jurisprudence ; Laboratories ; standards ; Pharmacy Administration ; legislation & jurisprudence

With the research and development of genetically engineered animals (GEAs) in breeding of new variety, xenotransplantation, bioreactor and disease model, biosafety issues of GEAs have attracted widespread attentions worldwide. So far, governments and agencies have established corresponding laws and regulations to regulate research and application of GEAs or their derived products. We reviewed research contents, evaluated principles, policies and procedures for biosafety of GEAs, also enumerated upcoming approved products of GEAs. Finally, we suggested perspectives of research and application of GEAs or their derived products.
Agriculture ; economics ; legislation & jurisprudence ; Animals ; Animals, Genetically Modified ; genetics ; growth & development ; Biotechnology ; economics ; legislation & jurisprudence ; Food Safety ; Food, Genetically Modified ; economics ; standards ; Laboratories ; standards

OBJECTIVE: To analyze the status quo of quantitative classification in Hunan Province catering industry, and to discuss the countermeasures in-depth. METHODS: According to relevant laws and regulations, and after referring to Daily supervision and quantitative scoring sheet and consulting experts, a checklist of key supervision indicators was made. The implementation of quantitative classification in 10 cities in Hunan Province was studied, and the status quo was analyzed. RESULTS: All the 390 catering units implemented quantitative classified management. The larger the catering enterprise, the higher level of quantitative classification. In addition to cafeterias, the smaller the catering units, the higher point of deduction, and snack bars and beverage stores were the highest. For those quantified and classified as C and D, the point of deduction was higher in the procurement and storage of raw materials, operation processing and other aspects. CONCLUSION The quantitative classification of Hunan Province has relatively wide coverage. There are hidden risks in food security in small catering units, snack bars, and beverage stores. The food hygienic condition of Hunan Province needs to be improved.
China ; Food Contamination ; prevention & control ; Food Microbiology ; Food Services ; organization & administration ; Foodborne Diseases ; prevention & control ; Hygiene ; Restaurants ; legislation & jurisprudence

The FDA risk evaluation and mitigation strategy (REMS) aims to drugs or biological products known or potential serious risk management. Analysis with the example of the content of the Onsolis REMS named FOCOS. Our country can be reference for the analysis of relevant experience and establish a scientific evaluation mechanism, strengthen the drug risk consciousness, promote the rational drug use, organic combined with the before-marketing and post-marketing evaluation of traditional Chinese medicine, and promote the evaluation of risk management of the drug development and improvement.
Guidelines as Topic ; Humans ; Legislation, Drug ; Medicine, Chinese Traditional ; adverse effects ; Product Surveillance, Postmarketing ; Risk Management ; methods ; United States ; United States Food and Drug Administration

China ; Consumer Product Safety ; legislation & jurisprudence ; Food ; Legislation, Food ; Proportional Hazards Models ; Risk Assessment

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.

Pharmacokinetics study is one of main components of pharmaceuticals development. Food and Drug Administration (FDA) approved Veregen as the first botanical drug in 2006. This article introduced FDA's requirement on pharmacokinetics study of botanical drug and pharmacokinetics studies of Veregen, summarized current requirement and status quo of pharmacokinetics study on traditional Chinese medicine (TCM) and natural medicine in China, and discussed about pharmacokinetics study strategy for TCM and natural medicine.
Catechin ; analogs & derivatives ; chemistry ; pharmacokinetics ; Chemistry, Pharmaceutical ; Drug Approval ; Drugs, Chinese Herbal ; chemistry ; pharmacokinetics ; Medicine, Chinese Traditional ; United States ; United States Food and Drug Administration ; legislation & jurisprudence