Suchergebnisse

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

Günümüzde sosyal ve iktisadi hayatta önemli bir yeri olan elektrik ürününe kamu kesimi gerek üretim gerekse iletim ve dağıtım aşamalarında sıklıkla müdahalede bulunmaktadır. Bu açıdan elektrik piyasası, 1970'lere kadar kamusal mülkiyete sahip kuruluşların idaresi altındayken özellikle 1990'lı yıllardan itibaren deregülasyon faaliyetleri sonucu daha çok özel sektörün etkisi altına girmiştir. Çalışmada elektrik sektöründeki regülasyonların nedenleri anlatılarak regülatörlerin bu süreçte konumuna Türkiye ve dünya örnekleriyle yer verilmiştir. Türkiye'de elektrik tüketiminde dışa bağımlı bir yapının bulunması, yapılacak regülasyonların da kapsamını daraltmaktadır. Uzun vadeli ve geniş kapsamlı yapısal regülasyonlar yerine kısa vadeli ve cari sorunların çözümüne yönelik regülasyonların varlığı sektör açısından negatif yönlü etkide bulunmaktadır. Bununla birlikte 1990'lı yıllardan itibaren sektördeki katılımcıların artması, rekabet açısından pozitif yönlü bir gelişme olduğu düşünülmektedir.

in this study conducted a study of the ratio legis regulation of the authority of the Regional Representative Council of the Republic of Indonesia (DPD RI) in Supervision of Draft Regional Regulations and Regional Regulations contained in Article 249 paragraph (1) letter j of Law Number 2 of 2018 concerning the Second Amendment to Law Number 17 of 2014 concerning Regional People's Consultative Assembly, People's Representative Council, Regional Representative Council, and Regional People's Representative Council (MD3 Law). This research is normative legal research with a statutory and conceptual approach. The results of this study are the legislative authority ratio of the DPD RI in supervising the draft of regional regulations and regional regulations to strengthen the function of the DPD RI within the framework of the unitary state of the Republic of Indonesia, especially in maintaining the harmonization of regulations at the central level with regulations at the regional level in the form of draft regional regulations and regional regulations.

Book ; The concept of governance in recent years has evolvedwith the introduction of information and communication technologies (ICT). Governments can now provide services without the need for the traditional face-to-face interaction.This undoubtedly represents a marked change; more so, for African countries whose governance measures are increasingly measured by their ability to reduce bureaucracy levels through the use of e-governance.1 In this model, a government is expected to incorporate three types of interactions namely: governmentto- government (G2G), government-to-business (G2B) and government-to-citizen (G2C). It is not surprising therefore that e-government has become an important theme and benchmark for the assessment of development via the ability to facilitate government services through ICT initiatives such as web portals. As most African national regulatory authorities (NRAs) already have a website or are in the process of establishing one, it is clear that this is viewed as an important or necessary activity. A website provides a fundamental window to realise the true spirit of egovernment. A properly built website provides citizens and other stakeholders with one of the best interfaces to the regulatory agency. It allows for self-service around the clock and reduces long queues and time as is evident in many African government agencies. In addition, international and local businesses can search for and even apply for certain facilities online without having to make a physical journey to the government agency. A website thus becomes a virtual representation of the entire organization in cyberspace (Wattegama 2007). As Mahan (2005) correctly observes, the importance of a national telecom regulatory authority website can never be underestimated. A NRA is one of the key government agencies in any country. It is the apex body that is largely responsible for the healthy growth of the telecom sector and the diffusion of telecom services to the public at all levels. It serves a large group of stakeholders varying from citizens and consumers to incumbent operators and prospective investors. Regulators set standards for transparency and accountability and thus, a well-designed and informative website will also demonstrate the extent and facility with which the NRA uses the technologies and services it regulates. A well-maintained website increases confidence in the regulator's skills and capabilities and thus provides a window upon which to evaluate the level of e-governance within a country. While there exists a plethora of e-government initiatives taking place within African governments, supported by international agencies, actual analysis of the type of services provided using e-based technologies has received little attention or speculation as to what constitutes effective components. Focusing on African telecomregulatory authorities, this survey follows from a similar study carried out during March-April 2004 (Mahan 2005)which focused on 22 AfricanNRAwebsites. Unlike the previous study however, this study evaluates a total of 30 countries out of 54 countries in Africa. The increase in number no doubts marks an increase over the past four years in the use of websites as a tool in regulation.

Over the past two decades, the authorities in charge of the regulation of sectors as diverse as Energy, Postal services, Electronic communications, Transports, Banking, Insurance and Securities have increased on a national level as well as on an European level. Imposed by Legislation, or free, in order to obtain impartiality and credibility, this European movement of creation of regulators can face some difficulties. Whatever the structure of these authorities, the extent of their powers, their degree of independence or their quest for Legitimacy, the solutions adopted to institutionalise regulation vary widely from a State to another, this diversity greatly affects the unity of this legal category. However and despite the absence of any harmonised framework, a common purpose animates these authorities which is to supervise, monitor, secure and protect. Due to different national and European experiences, this established fact raises issues about the possibility and also the opportunity of building a regulatory authority model in network utilities and in financial sectors that could guide the States as well as the European Union ; Au cours des deux dernières décennies, des autorités chargées de la régulation de secteurs aussi divers que l'énergie, les postes, les communications électroniques, les transports, la banque, l'assurance et les valeurs mobilières se sont multipliées aussi bien à l'échelle nationale qu'à l'échelle de l'Union européenne. Contraint par le droit dérivé, ou libre, à des fins d'impartialité et de crédibilité, ce mouvement européen de création des autorités de régulation n'est toutefois pas sans poser un certain nombre de difficultés. Qu'il s'agisse de la structure des autorités, de l'étendue de leurs pouvoirs, de leur degré d'indépendance ou de leur quête de légitimité, les solutions retenues pour institutionnaliser la régulation varient fortement d'un Etat à l'autre, cette diversité nuisant grandement à l'unité de cette catégorie juridique. Malgré l'absence de régime uniforme, des finalités ...

Over the past two decades, the authorities in charge of the regulation of sectors as diverse as Energy, Postal services, Electronic communications, Transports, Banking, Insurance and Securities have increased on a national level as well as on an European level. Imposed by Legislation, or free, in order to obtain impartiality and credibility, this European movement of creation of regulators can face some difficulties. Whatever the structure of these authorities, the extent of their powers, their degree of independence or their quest for Legitimacy, the solutions adopted to institutionalise regulation vary widely from a State to another, this diversity greatly affects the unity of this legal category. However and despite the absence of any harmonised framework, a common purpose animates these authorities which is to supervise, monitor, secure and protect. Due to different national and European experiences, this established fact raises issues about the possibility and also the opportunity of building a regulatory authority model in network utilities and in financial sectors that could guide the States as well as the European Union ; Au cours des deux dernières décennies, des autorités chargées de la régulation de secteurs aussi divers que l'énergie, les postes, les communications électroniques, les transports, la banque, l'assurance et les valeurs mobilières se sont multipliées aussi bien à l'échelle nationale qu'à l'échelle de l'Union européenne. Contraint par le droit dérivé, ou libre, à des fins d'impartialité et de crédibilité, ce mouvement européen de création des autorités de régulation n'est toutefois pas sans poser un certain nombre de difficultés. Qu'il s'agisse de la structure des autorités, de l'étendue de leurs pouvoirs, de leur degré d'indépendance ou de leur quête de légitimité, les solutions retenues pour institutionnaliser la régulation varient fortement d'un Etat à l'autre, cette diversité nuisant grandement à l'unité de cette catégorie juridique. Malgré l'absence de régime uniforme, des finalités communes animent pourtant ces autorités : encadrer, contrôler, sécuriser et protéger. Au regard des différentes expériences nationales et européennes, cet état de fait amène alors à s'interroger sur la possibilité et l'opportunité de construire un modèle d'autorité de régulation dans les secteurs des services publics en réseaux et des finances dont les Etats et l'Union européenne pourraient s'inspirer

Drug Regulatory Authority is defined as an authority appointed by the government to administer the granting of marketing authorization/approval of pharmaceutical products and biologicals in a country. It is also called as the Licensing Authority or Marketing Authority. The Drug Regulatory Authority of India is the Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare (MOHFW). Pharmaceutical Dossier of India is the major document required for the process of marketing approval of the pharmaceutical products and biologicals in India. Its content and format follows the Common Technical Document (CTD) as set out by the International Conference on Harmonization (ICH). The CTD of India is organized into 5 Modules. The information required under each module is suitably detailed in this article

The year 2003 involved a considerable change in Hungarian energy market. Liberalization of the formerly fully regulated electricity market began, and some practical experiences already presented themselves, as well as the new act on partial market-opening of the gas-segment came into being. The lifting of the monopole situation raised some theoretical and practical questions, on which the answer was given on the one hand by the rethought regulation, on the other hand by actors entering the market. In both areas there are interesting conclusions to be drawn from the foregoing events and from the experienced phenomena as well. In this study we endeavour to provide a resume about the theoretical background concerning the governmental regulation of the situations mentioned above.

Purpose of the article: The purpose of this article is to summarize the approaches used and to research the challenges for regulatory agencies consolidation in order to reduce administrative burdens for business. This article analyses the activity of Lithuanian and EU regulatory agencies which are supervising business with regard to identify potential and arising challenges of optimising the performance of regulatory agencies. Methods: review of academic and legal literature, comparison, synthesis, statistical data analysis. Scientific aim: The aim of this article is to analyse the activities of regulatory agencies of Lithuania and European Commission and evaluate the actions in order to reduce administrative burdens as well as to identify the consolidation problem areas of regulatory agencies. Findings: The results of the analysis shows, that a unified list of regulatory agencies is not in use and the research and other reform action taken by supervising authorities is being done using different sets of regulatory agencies, what leads to increasing of administrative burdens and ineffective regulatory agencies consolidation. Conclusion: The results of research shows that it is necessary to compile a clear, united and unified list of regulatory agencies. Also it is important to carry on consolidation of controlling institutions and merging regulatory agencies to achieve a clear responsibility for the controlled areas and new ways to implement information technologies should be provided.

Summary This indicator describes the income generated from the provision of Environmental and regulatory services by every Local Authority in England since 2007. Environmental and regulatory services income is calculated from any sales, fees and charges, as well as other types of income that are associated with delivering such services. Technical description The indicator was compiled from annual revenue outturn estimates of Local Authority (LA) revenue expenditure and financing. The Environmental and regulatory services income is calculated from the sum of a) sales, fees and charges and b) other types of income generated by these services, and thus does not include central government funding, capital gains or council tax. Income values are expressed in thousands (£) and presented on the basis of financial years, i.e. from April 1st to March 31st. Since some services are provided in Upper Tier and others in Lower Tier LAs, individual income figures from Upper Tier LAs were distributed to Lower Tier LAs based on annual population ratios (indicator FIN_07_43L), and Lower Tier LA income was distributed to Upper Tier LAs by aggregating (indicator FIN_07_43U). Income values from historic LA geography have been referenced to the 2018 LA geography. This includes changes in name/codes, merges, or splits of old LAs to new LAs based on population ratios for that year. The services income generated is expressed as the total amount as well as per capita, for direct comparisons. However, annual figures were not adjusted for inflation.

This article analyses regulatory innovation. It considers, in particular, how a regulatory environmental agency has been encouraged to innovate in the area of biopesticides. The literature on regulatory innovation is reviewed, the discussion situated within Moran's theory of the regulatory state. It considers to what extent innovation has occurred within the agency, looking at its proactive stance, and how unusually for a regulatory body it has negotiated new policy spaces in which to operate. The article looks at the contextual drivers and also the exogenous and endogenous pressures behind the innovation. It shows how the executive has intervened in order to promote more use of biopesticides and how pressure is also being exerted within the regulatory authority. By using the existing literature and empirical evidence a framework is outlined for explaining the likelihood of regulatory innovation occurring in regulatory agencies.

Bill introduced by the Texas Senate relating to the regulatory authority of the commissioner of insurance and the Texas Department of Insurance.

AbstractThis article uses the concept of regulatory cultures to understand the (dis)embedding of "independent" water regulation in India. It analyzes the specific case of the Maharashtra Water Resources Regulatory Authority and explores how discourses and practices (1990–2015) shaped the regulatory development in the water sector. By documenting the practices of meaning‐making of "independent" regulation, the paper queries the process(es) of subnational regulatory diffusion and analyzes how water regulation is translated, negotiated, contested, and subverted as situated meanings evolve in the process. Taking an anthropological approach to studying the State and regulation, the article demonstrates how and why the State remains at the very center of the regulatory project in the water sector in India.