regulatory authorities
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2022 ◽  
pp. 875512252110515
Author(s):  
Todd A. Boyle ◽  
Bobbi Morrison ◽  
Thomas Mahaffey

Background: Professional regulatory authorities play a critical role in protecting public interest. Yet, there is a growing view that trust in regulatory authorities may be on the decline. Objective: Awareness has been identified as important for maintaining trust. However, research that examines public awareness and trust in pharmacy regulatory authorities (PRAs) is lacking. This research explores public awareness and trust of PRAs and presents recommendations to enhance PRA communication strategies. Methods: An online survey was conducted with the Nova Scotia (Canada) public in 2020. Adopting classifications from the Communications literature, 3 media generations were explored: newspaper, television, and the Internet. The χ2 test of independence and Kruskal-Wallis H test were adopted to explore differences between the generations. Results: Six hundred sixty-two usable surveys were obtained. Over 80% of those surveyed were aware of the existence of the PRA. Those who had heard of the PRA were most aware of its operational responsibilities and less aware of its governance. The Internet Generation was more aware that the PRA includes members of the public in its decision making than expected and showed increased trust toward the PRA versus the other media generations. Conclusion: The findings should help inform PRA communication plans and set baselines to assess whether such plans enhance awareness. Future studies should explore additional aspects of PRA awareness and trust, perform comparisons across pharmacy jurisdictions, and develop and test models of the relationship between PRA awareness and various dimensions of institutional trust.


2021 ◽  
Vol 7 (4) ◽  
pp. 52-60
Author(s):  
A. S. Nemchenko ◽  
S. О. Lebed

The problem of drug counterfeiting is global; therefore, it is relevant for all countries of the world. However, the effectiveness combating the spread of counterfeit medicines (CM) differs in different countries, as evidenced by data on the level of counterfeit. Ensuring proper quality control of drugs in all areas of their circulation requires national regulatory authorities to systematically address these urgent problems; primarily, this concerns the pharmaceutical legislation to counteract the spread of counterfeit medicines and medical devices (MD), as well as to implement the effective state policy in this extremely important area that determines the national security of the state.


Author(s):  
M. Charmila ◽  
M. P. Venkatesh ◽  
G. Ramya Shree

With the evolving technology and changing regulations, the medical device sector is set to grow quickly soon. Even though they are an integral part of patient care they present several unique problems which are not sufficiently addressed by the device manufacturer or the medical community in general. Medical device is widely used by professionals in a clinical setup, by patients, family members at home. As step towards better understanding the rules, regulations, and the required reforms for the safe use of medical devices various measures taken by different regulatory authorities to ensure the minimization of use error are discussed. Human factor engineering and ergonomics are considered while designing a medical device. It is evident that all the stakeholders involved contribute to the safety of the medical device keeping in mind the welfare of the patient but is that enough and what can be done is discussed in this review work.


Author(s):  
Shivali Rahi ◽  
Ajay Kumar ◽  
Arpana Rana

Considering the new Coronavirus pandemic, the interest for antimicrobial products, for example, sanitizers and hand sanitizers are soaring. Regulatory authorities are performing their function by giving approvals to hand sanitizers in various countries through various regulations and marketing authorization procedures. The point of this article is to help in understanding the administrative prerequisites expected to bring the hand sanitizers or sanitizer items into various business sectors, just as the current administrative exceptions and interval gauges set up to help react to COVID-19.


2021 ◽  
Vol 10 (2) ◽  
pp. 121-134
Author(s):  
Adam Szafrański

In its judgement C-378/19, the Court of Justice of the European Union responded to the question for a preliminary ruling referred by the Slovak Constitutional Court. The ECJ found in this judgement that Directive 2009/72/EC must be interpreted as not precluding withdrawal of the competence of the President of a Member State to appoint and dismiss the chairperson of the national regulatory authority, and conferral of the same power to the Member State’s government. Similarly, allowing the participation of the Ministers of the Environment and of the Economy in certain price-setting procedures does not violate the decision-making independence of the national regulatory authority. In his commentary, the author cites the line of argument in the judgement and presents the political context in Slovakia that led to the preliminary question. The author then comments approvingly on the judgement, noting that the Court rightly refrained from assessing the political situation in Slovakia, instead opting to focus on the law. At the end of the commentary, the author makes remarks of a general nature relating to the independence of national regulatory authorities.


2021 ◽  
pp. 24-28
Author(s):  
Т.А. Диканова

Рассматривается проблема приведения в нормативное состояние мостов и путепроводов на автодорогах. Приводятся нарушения, связанные с ненадлежащим содержанием и контролем за содержанием этих объектов, а также анализ нормативных правовых актов и предложения по устранению нарушений. The article deals with the actual problem of bringing bridges and overpasses on highways into a normative state; the violations identified by the regulatory authorities related to the improper maintenance and control over the maintenance of these artificial objects are presented, the analysis of regulatory legal acts regulating this maintenance and control is given, proposals for eliminating violations are given.


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