scholarly journals Regulatory procedures for emergency approval of medical products by regulatory agencies

2021 ◽  
Vol 9 (2) ◽  
pp. 1-5
Author(s):  
G HariCharan ◽  
Kishore Kumar Ramoju ◽  
Suhana S ◽  
Yamini Lindait
Keyword(s):  
Mutual Recognition ◽  
Regulatory Agencies ◽  
Important Data ◽  
Medical Products ◽  
Large Group ◽  
Usual Procedure ◽  
Contagious Diseases ◽  
Mutual Recognition Agreement ◽  
Regulatory Bodies ◽  
Regulatory Acceptance

Emergency use authorization of medical products by the regulatory agencies is not a usual procedure; it happens to cope with unanticipated health emergencies affecting a large group of population, these can be because of outbreak agents like virus, bacteria, etc., which can cause contagious diseases. Contagious diseases are classified into an outbreak, epidemic and pandemic disease, based on size and intensity of spread of the disease. Epidemic and Pandemic disease conditions such as CoVID-19 will trigger the emergency use authorization of products that help in the control, prevention and/or cure for the disease. EMA and FDA are well known advanced regulatory bodies, with eminent procedures for approval of the medication, harmonization of the standards as per the global regulatory acceptance. However, there are some differences between the two, in case of initiating the procedure, timelines, data required for approval of products under the emergency use. This article focuses on emergency approval of medications, regulations involved in the approval of medications and vaccines by EMA and FDA, some of the important data companies or sponsors need to submit to the regulatory bodies for approval, verification procedure and timelines for evaluation of manufacturer submitted data. Mutual recognition agreement and timeline of Remdesivir for approval by EC and FDA.

Facilitating Mobility for Psychologists Through a Competency-Based Approach for Regulation and Accreditation: The Canadian Experiment

2002 ◽  
Vol 7 (3) ◽  
pp. 203-212 ◽  
Author(s):  
Janel G. Gauthier
Keyword(s):  
Training Programs ◽  
Mutual Recognition ◽  
Mutual Recognition Agreement ◽  
Common Framework ◽  
Regulatory Bodies ◽  
Competency Based ◽  
The Government ◽  
Professional Psychologists

Professionals in Canada are regulated by provincial/territorial bodies that have their own requirements for licensing and registration. Because these requirements vary tremendously across jurisdictions, the ability of Canadians to work anywhere in the country is greatly limited. In response to pressures for greater mobility, federal, provincial and territorial governments agreed in 1994 to take steps to remove or reduce barriers to the movement of workers in Canada. Under this agreement, regulatory bodies within each jurisdiction were asked to comply voluntarily with the obligations of the agreement or else the government would adopt and maintain measures to ensure such compliance. To address the issue of mobility, Canadian psychologists have taken a competency approach. This paper presents the template that provided a common framework or language for the mutual recognition of competencies for the purpose of mobility in Canada and the results of this process as reflected in the Mutual Recognition Agreement signed by the Canadian regulatory bodies of psychologists in June 2001. The paper also highlights the role of accreditation of training programs in the recognition of professional psychologists for the purpose of mobility and the influence that training programs may have on standards for licensure or registration.

Study on Supervision Mode of Floating Nuclear Power Plant With Small Modular Reactor

2018 ◽  
Author(s):  
Lei Wan ◽  
Guiyong Li ◽  
Min Rui ◽  
Yongkang Liu ◽  
Jue Yang
Keyword(s):  
Power Plant ◽  
Nuclear Power Plant ◽  
Nuclear Power ◽  
Government Regulation ◽  
Mutual Recognition ◽  
Nuclear Safety ◽  
Small Modular Reactor ◽  
License Application ◽  
Mutual Recognition Agreement ◽  
Nuclear Installation

A floating nuclear power plant (FNPP) with small modular reactor (SMR) is a combination of a civilian nuclear infrastructure and an offshore installation, which is defined as a floating nuclear facility. The article draws the lessons from studying of the engineer combination like Floating Production Storage and Offloading (FPSO) under the regulation of several government departments. It puts forward recommendations for license application and government regulation as follows in consideration with current license application for nuclear power plant and ship survey. A FNPP shall follow the requirements of construction, fueling and operation for civil nuclear installation combined with ship survey. Application is submitted to nuclear safety regulator for construction permit, while the design drawings shall be submitted to department of ship survey which checks the drawings whether meet the requirements of ship survey, considering some nuclear safety needs. The result of ship survey shall be represented in the safety analysis reports. The construction and important devices manufacturing shall be under the supervision of nuclear installation regulators and ship survey departments. In conclusion, National Nuclear Safety Administration (NNSA) and Maritime Safety Administration of the People’s Republic of China (MSA) shall establish united supervisory system for SMR on sea in China. It is suggested that NNSA is in charge of the overall safety of a FNPP, while MSA is responsible of the ship survey. The operator shall undertake obligation of a FNPP and evaluate the ship cooperating with experienced agency. It is suggested that government departments build the mutual recognition agreement of safety review. It is better to solve the vague questions by coordination.

scholarly journals AKUNTAN DAN ERA KETERBUKAAN ARUS LALU LINTAS JASA

2017 ◽  
Vol 1 (1) ◽  
pp. 1-14
Author(s):  
Vidia Gati
Keyword(s):  
Mutual Recognition ◽  
Skilled Labour ◽  
Mutual Recognition Agreement

Profesi akuntan adalah salah satu profesi yang mendapatkan sertifikasi dari negara negara ASEAN berdasarkan Mutual Recognition Agreement (MRA sehingga nantinya akan memudahkan lintas profesi diantara Negara tersebut. Adanya gap antara jumlah akuntan yang tersedia dan yang dibutuhkan akan menimbulkan persoalan yaitu serbuan tenaga kerja asing di masa arus lalu lintas jasa benar benar terbuka. Ikatan Akuntan Indonesia sudah melakukan berbagai aktifitas untuk mempersiapkan masa tersebut, namun hendaknya perhitungan realistis perlu dikedepankan mengingat struktur sumber daya manusia di Indonesia didominasi oleh low skilled labour sehingga opsi menunda pemberlakuannya mungkin dapat diperhitungkan untuk memberi kesempatan anak bangsa mencapai posisi strategis daripada posisi sebagai buruh di negeri sendiri.

scholarly journals Conflict of Interest Between Regulatory Agencies on Telecommunication Sector And Consequences of Improper Telecommunication Mast Installation in Nigeria

Law and World ◽  
2021 ◽  
Vol 7 (5) ◽  
pp. 47-59
Keyword(s):  
Conflict Of Interest ◽  
Effective Means ◽  
Environmental Hazards ◽  
Regulatory Agencies ◽  
Environmental Standards ◽  
Telecommunication Sector ◽  
Public Places ◽  
Regulatory Bodies ◽  
Materials Used ◽  
National Environmental

This paper examines various laws governing telecommunication installations in Nigeria with a view to addressing the perceived shortcomings in the laws. While the National Environmental Standards Regulatory and Enforcement Agency Act (NESREA Act) and the National Communications Commission (NCC Act) have been enacted to solve the problems associated with the effects of telecommunication mast installation in public places, the outcome of these laws seem inadequate for failure to provide effective means of enforcing same. The study considered the provisions of NESREA Act which is the principal Law enacted for ensuring that environ- mental standards are maintained and protected in Nigeria and the provisions of NCC Act which is the law that establishes the principal body which regulates telecommunication installations in Nigeria as well as other legislations. While NESREA in its Regulation provided for a setback of 10 metres, the NCC Act provided for a setback of 5 metres, which often conflicts and put victims at disadvantage and also conflict between the two regulatory bodies. It was observed that serious environmental hazards are linked to installation of tele- communication masts within/close to residential premises. Among these are leukemia, cancer, cracks on the buildings, pollution, such as water, land and air. The problems also include telecommunication masts falling on buildings and sometimes death due to sub- standard materials used in the installation as against the stated standard by the controlling regulatory bodies.

OP143 Assessment Of mHealth Apps: Is Current Regulation Policy Adequate?

2019 ◽  
Vol 35 (S1) ◽  
pp. 33-33
Author(s):  
Magdalena Moshi ◽  
Jacqueline Parsons ◽  
Rebecca Tooher ◽  
Tracy Merlin
Keyword(s):  
Medical Device ◽  
Clinical Evaluation ◽  
Clinical Decision Making ◽  
Clinical Care ◽  
Clinical Decision ◽  
International Standards ◽  
Regulatory Agencies ◽  
Guidance Document ◽  
Regulatory Bodies ◽  
Mhealth Apps

IntroductionAustralians are adjusting to mobile health (mHealth) applications (apps) being used in clinical care. The nature of apps presents unique challenges (e.g. rapid lifecycle) to mHealth regulation. The risks they pose are mainly through the information they provide and how it is used in clinical decision-making. This study explores the international regulation of mHealth apps. It assesses whether the approach used in Australia to regulate apps is consistent with international standards and suitable to address the unique challenges presented by the technology.MethodsA policy analysis was conducted of all nine member jurisdictions of the International Medical Device Regulator's Forum (IMDRF), to determine if their regulatory agencies addressed the IMDRF recommendations relevant to the clinical evaluation of mHealth apps. Case-studies (submission to regulatory agencies) were also selected on varying types of regulated apps (standalone, active implantable, etc.) and assessed relative to the principles in the IMDRF's software as a medical device (SaMD): Clinical evaluation (2017) guidance document.ResultsAll included jurisdictions evaluated the effectiveness of mHealth apps, assessing the majority of the key sub-categories recommended by SaMD: Clinical evaluation. The submissions and jurisdictional regulatory bodies did not address the IMDRF safety principles in terms of the apps’ information security (cybersecurity). Furthermore, by failing to use the method recommended by the IMDRF (risk-classification), none of the submissions or jurisdictions recognized the potential dangers of misinformation on patient safety.ConclusionsNone of the approaches used by global regulatory bodies adequately address the unique challenges posed by apps. Australia's approach is consistent with app regulatory procedures used internationally. We recommend that mHealth apps are evaluated for cybersecurity and are also classified using the IMDRF risk-categories so as to fully protect the public.

scholarly journals International Cooperation as a Prerequisite for Improvement of Access to Orphan Biologic Medicines

2021 ◽  
Vol 14 (2) ◽  
Author(s):  
Zbigniew Więckowski
Keyword(s):  
International Cooperation ◽  
Rare Diseases ◽  
Patent Protection ◽  
Positive Impact ◽  
Mutual Recognition ◽  
Orphan Drugs ◽  
Economic Incentives ◽  
Regulatory Agencies ◽  
The Usa ◽  
The Eu

Rare diseases constitute a global problem. Worldwide, 350 million people suffer from such diseases. The number of diagnosed cases are on the rise. Only a small percentage of those suffering have the opportunity to be treated with modern therapies. Medicines used to treat rare diseases are called orphan drugs. Biologic medicines developed for orphan drug indications, besides patent protection, have a period of regulatory and market exclusivity. After this period of time has elapsed, access to orphan drugs could be improved by the introduction of biosimilar medicines. The biggest challenge is to develop effective legal, tax and economic incentives to stimulate the development of biosimilar medicines for orphan indications. The regulatory agencies - EMA in the EU and the FDA in the USA - play a key role in increasing access to orphan biologics. Undoubtedly, the international cooperation, especially the mutual recognition of registration procedures between countries, and the creation of a common vocabulary and the unification of incentives for the pharmaceutical industry would have the positive impact on access to modern therapies.

The Study on Selecting Qualification Items and Preparing Strategies for Mutual Recognition Agreement

2017 ◽  
Vol 6 (1) ◽  
pp. 105-131
Author(s):  
Myung-Hun Lee ◽  
◽  
Soon-Hae Kang ◽  
Seung-Il Na ◽  
Su-Bong Uh ◽  
...  
Keyword(s):  
Mutual Recognition ◽  
Mutual Recognition Agreement

INTER-RELATED RESPONSIBILITIES FOR MILK PRODUCTION AND QUALITY CONTROL1

1969 ◽  
Vol 32 (9) ◽  
pp. 350-353
Author(s):  
Abraham E. Abrahamson
Keyword(s):  
Public Health ◽  
Milk Production ◽  
Control Program ◽  
Regulatory Agencies ◽  
The Public ◽  
The Past ◽  
Maintenance Program ◽  
Regulatory Bodies ◽  
High Level ◽  
Very High

The capacity to work cooperatively, industry with the various agencies, concerned with milk production and quality control has been demonstrated. Cooperation among the agencies having responsibility in milk control, in a period of looming budget crisis, is more imperative than ever. While all the problem bearing on the public health aspects of milk control have not been solved, there do not appear to be any serious threats beyond the problem to provide maintenance efforts to assure continuance of the gains made. For the maintenance program it seems a very high level of cooperation among regulatory agencies is necessary and continued efforts of industry to work with regulatory bodies must be encouraged. Solving of new problems may have to be under-taken with out added resources, therefore making it necessary to develop better techniques to tackle new tasks without losing control in the older and more traditional areas. Inter-related efforts which were carefully developed in the past will be needed to supplement as well as complement to prevent deficits from affecting the whole coordinated milk control Program.

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