Producing counterfeits and put them in circulation in Ho Chi Minh market - the biggest drug market of Vietnam - is a true thing. This real problem is blamable and now, it becomes a pressing matter, of The Vietnamese Drug Administration because of bad effects caused by the counterfeits on the fields following: they caused worse effects on patient's situations. They caused heavy losses of finance for patients and true laboratories. And these things create damage to home country's economies. They caused a confused situation to drug market and this thing pushes up increasing more difficulties for The Drug Administration and the Health Ministry. They make reducing the confidence of people on drugs that made in Vietnam and one more important thing is to decline the prestige of The Vietnamese Pharmacy before international friends. This is our first research on the problem with a view to making contribution to development of the national pharmacy
Pharmaceutical Preparations ; Drug Approval

On the basis of introducing FDA's regulatory measure and relevant requirement for life-cycle management of combination product, this paper aims to discuss corresponding countermeasure for supervision system construction in consideration of domestic drug-device combination product's current situation, in order to promote innovative development of relevant industries.
Device Approval ; Drug Approval ; United States ; United States Food and Drug Administration

Modern and international studies on new traditional Chinese medicines are the main trend of the development of traditional Chinese medicines at present. In Australia, new traditional Chinese medicines refer to complementary medicines, which are mainly registered and launched as listed medicines. The application documents of registered (listed) medicines in Australia mainly cover detailed description of active pharmaceutical ingredients, pharmacological and toxicological studies, dosage form and adverse effects. Each part has detailed specifications and instructions, which helps ensure that applicants could accurately understand the requirements in application for registering (listing) medicines, and provides very important reference to the studies and development of new traditional Chinese medicines in China.
Australia ; Drug Approval ; Drug Evaluation ; Medicine, Chinese Traditional

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

This study introduces the establishment and the situation before and after the reorganization of Center for Devices and Radiological Health (CDRH). Meanwhile, it sorted out the important changes in this reorganization of CDRH. CDRH optimizes regulatory decisions by integrating pre-marketing and post-marketing professionals for the total product lifecycle of medical devices, based on product line guidelines. Taking the sutatus of Chinese medical device supervision into consideration, this study put forward some thoughts on scientific supervision.
Device Approval ; Marketing ; United States ; United States Food and Drug Administration

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

A combination product is a new model of the medical product that incorporates at least two of the regulated component categories of device, drug, or biological product into one product. It has become a new hot point within the development of devices and drugs, and has brought about a new opportunity for device and drug industries and a new challenge for administration too. In the paper, the properties of combination products are summed up and the impact on device and drug industries are discussed.
Biological Products ; Device Approval ; Drug Industry ; instrumentation ; Drug-Eluting Stents ; Equipment and Supplies

Drug development is a lengthy, expensive, and complex process, and clinical development is the longest and the most expensive stage of drug development. To obtain market authorization of a new drug, applicants must prove the effectiveness and the safety of a drug through clinical trials. Korea has the same requirements for new drug approval as in developed countries and bridging data are required for approval of a new drug that was developed in another country. Clinical evaluation in humans consists of 3 phases, from phase 1 to phase 3, and the failure rates remain high while the clinical trial cost increases rapidly. Not only pharmaceutical sponsors but also patients and physicians want new, innovative medicines faster, simultaneously with improved productivity of drug development. With strong competition and market forces, the pressure to accelerate drug development and to predict the efficacy and safety profile of a drug candidate at an earlier stage is increasing. To improve the productivity of new drug development, modern principles of pharmaceutical sciences, clinical pharmacology, and information technology are being researched and employed by both health authorities and sponsors. Many global pharmaceutical companies are also pursuing geographical expansion strategies to enroll subjects faster among more diverse ethnic groups. To deliver innovative medicines to patients in a faster and more cost-effective ways, close and continuous collaboration among sponsors, academia, and health authorities is essential.
Cooperative Behavior ; Developed Countries ; Drug Approval ; Efficiency ; Ethnic Groups ; Humans ; Korea ; Pharmacology, Clinical

The EU is an international bridge of traditional Chinese medicine (TCM), and TCM in EU is of strategic importance. In this paper the progress on policies and regulations and approved products of herbal medical products in EU in 10 years were briefly reviewed, registration regulations were systematically, studied and some typical cases were analyzed. To provide reference for successful registration of TCM in EU and implementation of international strategy of TCM, five key elements (i. e. registration classification, approval procedure, approval authority, application product and application enterprise) to break through the registration barriers on TCM in EU were putted forwards correspondingly.
Drug Approval ; European Union ; Medicine, Chinese Traditional ; Policy ; Publications ; Social Control, Formal

This paper gives a brief introduction on the development of recognized consensus standards, the recognition working procedure and the overview of medical devices recognized consensus standards in USA, and analyzes the experience of the recognition management system in USA, aiming at providing a reference for the improvement of the medical device standard management system in China.
China ; Consensus ; Device Approval ; Equipment and Supplies ; standards ; Reference Standards ; United States ; United States Food and Drug Administration