Search results

The practice of neurosurgery has been complicated over the last 25 years by the enactment of a series of statutes that have significantly altered the time-honored means by which neurosurgeons manage their work. These laws deal with issues that neurosurgeons have not customarily had to consider. The author outlines some of the socioeconomic and political matters that led to the passage of these statutes. An assortment of the laws is then surveyed, to foster an appreciation for the variety and depth of health care law that affects neurosurgeons' practice and the delivery of care to their patients. Statutes discussed include the fraud and abuse laws, self-referral laws, the Emergency Medical Treatment and Labor Act, Health Insurance Portability and Accountability Act, and Employee Retirement Income Security Act.

Since 2010, two significant international regulations regarding medical device development have come into force, the amendment to the European Union (EU) Medical Device Directive (MDD) 2007/47/EC and the United States (US) Food and Drug Administration (FDA) Final rule on Medical Device Data Systems (MDDS). Adherence to these regulations is mandatory to be able to market a medical device in the respective region. The ability to understand these regulations and apply them to a development project can be difficult. The MDDS final rule changes the safety classification of a number of devices from Class III-high risk to Class I-low risk. The aim of this regulation is to make the process of achieving regulatory approval for manufacturers easier. The MDD aims to provide guidance for the development of medical devices to be marketed for use within the EU. It also provides defined pathways which manufacturers can follow in order to achieve regulatory approval. However, changes made as part of amendment to the directive have a direct impact on the development of medical devices. One of the most significant changes as part of this amendment is for software to potentially be considered as a medical device in its own right and potentially the only element in a medical device subject to regulatory conformance. These regulations have created confusion surrounding specific areas such as the use of mobile device applications for healthcare purposes. This article describes the key points of these latest regulatory changes that medical device manufacturers need to be aware of.

The practice of neurosurgery has been complicated over the last 25 years by the enactment of a series of statutes that have significantly altered the time-honored means by which neurosurgeons manage their work. These laws deal with issues that neurosurgeons have not customarily had to consider. The author outlines some of the socioeconomic and political matters that led to the passage of these statutes. An assortment of the laws is then surveyed, to foster an appreciation for the variety and depth of health care law that affects neurosurgeons' practice and the delivery of care to their patients. Statutes discussed include the fraud and abuse laws, self-referral laws, the Emergency Medical Treatment and Labor Act, Health Insurance Portability and Accountability Act, and Employee Retirement Income Security Act.

The practice of neurosurgery has been complicated over the last 25 years by the enactment of a series of statutes that have significantly altered the time-honored means by which neurosurgeons manage their work. These laws deal with issues that neurosurgeons have not customarily had to consider. The author outlines some of the socioeconomic and political matters that led to the passage of these statutes. An assortment of the laws is then surveyed, to foster an appreciation for the variety and depth of health care law that affects neurosurgeons' practice and the delivery of care to their patients. Statutes discussed include the fraud and abuse laws, self-referral laws, the Emergency Medical Treatment and Labor Act, Health Insurance Portability and Accountability Act, and Employee Retirement Income Security Act.

A strategic regulatory plan, with timelines and budget estimates, is vital to product development in the area of nutraceuticals. This report provides information on the regulatory environment in Canada, the U.S., and the European Community. It highlights key agencies and documents, as well as areas of evolving policy, to assist firms with regulatory planning. Although the key focus of this document is nutraceuticals and functional foods, other areas are covered since they are related and regulatory changes or developments could impact nutraceuticals. These areas include drugs for human and veterinary use, over-the-counter drugs, biologics and biosimilars, and cosmetics. ; Un plan stratégique de règlementation disposant d'un échéancier et de prévisions budgétaires est essentiel à la mise au point de produits nutraceutiques. Le présent rapport renferme de l'information sur le contexte règlementaire au Canada, aux États-Unis et en Europe. Il met en relief les principaux organismes et documents, ainsi que les changements en matière de politiques, afin d'aider les entreprises avec leur projet de règlementation. Bien que ce document touche principalement les nutraceutiques et les aliments fonctionnels, d'autres domaines y sont également traités dans la mesure où ils se rapportent à la règlementation ou à d'autres aspects ayant une incidence sur les nutraceutiques. Au nombre de ces domaines figurent les médicaments à usage humain et vétérinaire, les médicaments en vente libre, les produits biologiques, les biosimilaires et les cosmétiques. ; Peer reviewed: No ; NRC publication: Yes

The Russian government has already introduced some advanced trade facilitation (TF) measures, following the experience of developed countries. However, there have been no serious attempts made yet to conduct a comprehensive study of the TF environment to show a whole picture of the issue in Russia and identify the bottlenecks in its development path. This study centers on the following three questions. First, what is the current status of TF in Russia? Second, what is the regulatory environment where TF is found? Third, what policy implications can we derive from the study? To this end, this study examines the processes connected with the importation, exportation and transit of goods in Russia. It also evaluates TF-related policies, regulations, and the challenges ahead for Russia, and finally suggests some policy recommendations for the Russian government. As part of the UNESCAP TF unit, we adopted the expert survey approach to collect the data because this method is particularly useful in providing some independent assessment on complex, technical and specialized issues for which data is not readily available. Our in-depth investigation finds that the de facto implementation of many general measures is lagging far behind the legislation. In practice, it is not clear for traders how some regulations and processes work for them, or how easily those measures can be applied to their transactions. Bureaucracy and corruption remain very harmful factors, entailing higher trade costs in Russia. The most serious challenges faced by Russia in implementing TF measures are indicated as the lack of coordination between government agencies and the deficiency of political will. It is possible that local government agencies can start to undertake local initiatives and promote TF, but without centralized coordination among local agencies by Moscow, backed up by a strong political will, successful implementation of TF policies may not be achieved. Increasing the consultations with stakeholders through a national TF body, establishment of national single window, including an electronic one, and other measures such as risk management to improve the procedures and works of customs, should be prioritized in Russia.

Different regulatory authorities regulate the drug development in various countries of the world. Various Regulatory authority for generic drug application Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceutical and Medical Devices Agency (PMDA), Health Product and Food Branch (HPFB) Central Drug Standard of Organization (CDSO). Generic manufacturers may file an abbreviated New Drug Application (ANDA) that incorporates the safety/effectiveness data submitted by original innovator drug manufacturer and adds only bioequivalence studies. Therefore it is very difficult and challenging task to approve a drug by the manufacturing companies, simultaneously submitted in all the regulatory authorities. Regulatory authorities are responsible to ensure the quality, safety, and efficacy including manufacturing, distribution of the drug product. There is lot of challenges for the pharmaceutical industry to development and filling of generic drug application, which can be overcoming by the common format of submission. This is due to the different regulatory procedure of the various countries. Through the international conference on harmonization (ICH) process common technical documents (CTD) has been developed for USA, EU, JAPAN, INDIA AND CANADA. There are few differences in the dossier submission for among these five regions. To development of any generic drug product still we need strategic planning by these regulatory authorities. Keywords: Generic drug, Regulatory authority, Drug development, FDA, ANDA, ICH

As a result of European legislation passed in 2001 (Directive 2001/20/EC), all clinical trials, whether sponsored by industry, a major national body or charity, or done by a single academic investigator, must get approval from the Medicines and Healthcare products Regulatory Agency (MHRA) as well as obtaining ethical approval. This requires all studies to be carried out to the standards of 'Good Clinical Practice' and places burdens on investigators in terms of reporting adverse events and archiving. A new directive has been published in draft form that will finally define what is meant by Good Clinical Practice in Europe.

"Regulatory" doesn't have to equal "handcuffed." Even in light of increasing compensation regulations, plans can continue to reward, motivate, and attract employees without punishing them for their gains.