scholarly journals Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence

2016 ◽  
Vol 19 (2) ◽  
pp. 290
Author(s):  
Maki Matsuhama ◽  
Tomoko Takishita ◽  
Ryosuke Kuribayashi ◽  
Kazunori Takagi ◽  
Rika Wakao ◽  
...  
Keyword(s):  
Active Substance ◽  
Gap Analysis ◽  
Good Manufacturing Practice ◽  
World Health ◽  
The European Union ◽  
The South ◽  
Technical Requirements ◽  
Similarities And Differences ◽  
Human Use ◽  
Health Organization

Purpose. A gap analysis survey of international practices for Active Substance Master Files (ASMFs)/Drug Master Files (DMFs) of human use was conducted as a project of the ASMF/DMF working group of the International Generic Drug Regulators Pilot (IGDRP) to identify similarities and differences among ASMF/DMF procedures of 10 IGDRP members and 2 observers. Methods. We conducted a questionnaire survey and compared the following aspects: overall ASMF/DMF procedures, submission requirements for ASMFs/DMFs, assessment processes for ASMFs/DMFs, the technical requirements for active pharmaceutical ingredients (APIs), generation of assessment reports for ASMFs/DMFs, procedures for changing ASMF/DMF details, and Good Manufacturing Practice (GMP) inspection/certification of API manufacturers. Twelve organizations participated in this project: the Brazilian Health Surveillance Agency (Anvisa), the European Union (EU), Health Canada (HC), the Singapore Health Sciences Authority (HSA), the South African Medicines Control Council (MCC), the South Korean Ministry of Food and Drug Safety (MFDS), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), the Swiss Agency for Therapeutic Products (Swissmedic), the Taiwan Food and Drug Administration (TFDA), the Australian Therapeutic Goods Administration (TGA), the European Directorate for the Quality of Medicines & HealthCare (EDQM) (Observer) and the Prequalification Team (PQT) of the World Health Organization (WHO), which includes the PQT–Medicines (Observer). Results. Although there were many similarities among the participating agencies surveyed, there were also differences that should be discussed such as assessment processes of ASMFs/DMFs and Technical requirements for APIs. Conclusions. These differences revealed by this survey will be key considerations in order to facilitate the filing of ASMFs/DMFs globally and to establish a framework for sharing and utilizing information related to ASMFs/DMFs among IGDRP members in the future. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

scholarly journals Improving the Outcome of GMP Inspections by Improving Proficiency of Inspectors through Consistent GMP Trainings

2021 ◽  
Author(s):  
Solomon Shiihi ◽  
U G Okafor ◽  
Zita Ekeocha ◽  
Stephen Robert Byrn ◽  
Kari L Clase
Keyword(s):  
Regulatory Agency ◽  
Gap Analysis ◽  
Pharmacy Practice ◽  
Good Manufacturing Practice ◽  
Job Skills ◽  
World Health ◽  
Second Phase ◽  
Hands On ◽  
Who Checklist ◽  
Health Organization

Approximately 90% of the pharmaceutical inspectors in a pharmacy practice regulatory agency in West Africa have not updated their training on Good Manufacturing Practice (GMP) inspection in at least eight years. However, in the last two years the inspectors relied on learning-on-the job skills. During this time, the agency introduced about 17% of its inspectors to hands-on GMP trainings. GMP is the part of quality assurance that ensures the production or manufacture of medicinal products is consistent in order to control the quality standards appropriate for their intended use as required by the specification of the product. Inspection reports on the Agency’s GMP inspection format in-between 2013 to 2019 across the six geopolitical zones in the country were reviewed retrospectively for gap analysis. Sampling was done in two phases. During the first phase sampling of reports was done by random selection, using a stratified sampling method. In the second phase, inspectors from the Regulatory Agency from different regions were contacted on phone to send in four reports each by email. For those that forwarded four reports, two, were selected. However for those who forwarded one or two, all were considered. Also, the Agency’s inspection format/checklist was compared with the World Health Organization (WHO) GMP checklist and the GMP practice observed. The purpose of this study was to evaluate the reporting skills and the ability of inspectors to interpret findings vis-à-vis their proficiency in inspection activities hence the efficiency of the system. Secondly, the study seeks to establish shortfalls or adequacies of the Agency’s checklist with the aim of reviewing and improving in-line with best global practices. It was observed that different inspectors have different styles and methods of writing reports from the same check-list/inspection format, leading to non-conformances. Interpretations of findings were found to be subjective. However, it was also observed that inspection reports from the few inspectors with the hands-on training in the last two year were more coherent. This indicates that pharmaceutical inspectors need to be trained regularly to increase their knowledge and skills in order to be kept on the same pace. It was also observed that there is a slight deviation in placing sub indicators under the GMP components in the Agency’s GMP inspection format, as compared to the WHO checklist.

scholarly journals The politics of crisis management by regional and international organizations in fighting against a global pandemic: the member states at a crossroads

2021 ◽  
pp. 002085232098451
Author(s):  
Steven Van Hecke ◽  
Harald Fuhr ◽  
Wouter Wolfs
Keyword(s):  
Crisis Management ◽  
International Organizations ◽  
Governance Structure ◽  
Added Value ◽  
World Health ◽  
The European Union ◽  
Member States ◽  
Global Pandemic ◽  
Turbulent Times ◽  
Health Organization

Despite new challenges like climate change and digitalization, global and regional organizations recently went through turbulent times due to a lack of support from several of their member states. Next to this crisis of multilateralism, the COVID-19 pandemic now seems to question the added value of international organizations for addressing global governance issues more specifically. This article analyses this double challenge that several organizations are facing and compares their ways of managing the crisis by looking at their institutional and political context, their governance structure, and their behaviour during the pandemic until June 2020. More specifically, it will explain the different and fragmented responses of the World Health Organization, the European Union and the International Monetary Fund/World Bank. With the aim of understanding the old and new problems that these international organizations are trying to solve, this article argues that the level of autonomy vis-a-vis the member states is crucial for understanding the politics of crisis management. Points for practitioners As intergovernmental bodies, international organizations require authorization by their member states. Since they also need funding for their operations, different degrees of autonomy also matter for reacting to emerging challenges, such as the COVID-19 pandemic. The potential for international organizations is limited, though through proactive and bold initiatives, they can seize the opportunity of the crisis and partly overcome institutional and political constraints.

scholarly journals Mental healthcare in Hungary: contradictions and possibilities

2010 ◽  
Vol 7 (2) ◽  
pp. 36-38 ◽  
Author(s):  
Tamás Kurimay
Keyword(s):  
Health Spending ◽  
Mental Healthcare ◽  
World Health ◽  
Minority Population ◽  
Official Language ◽  
The European Union ◽  
Middle Income ◽  
The Republic ◽  
Health Organization ◽  
The Uk

The Republic of Hungary is a landlocked country of 93000 km2 in central Europe; it is bordered by Austria, Slovakia, Ukraine, Romania, Serbia, Croatia and Slovenia. Its official language is Hungarian. Hungary joined the European Union (EU) in 2004. About 90% of the population of c. 10 million is ethnically Hungarian, with Roma comprising the largest minority population (6–8%). Currently classified as a middle-income country with a gross domestic product (GDP) of $191.7 billion (2007 figure), Hungary's total health spending accounted for 7.4% of GDP in 2007, less than the average of 8.9% among member states of the Organisation for Economic Co-operation and Development (OECD, 2009). The proportion of the total health budget for mental health is 5.1%, which is low when compared with, for instance, the UK (England and Wales 13.8%, Scotland 9.5%) (World Health Organization, 2008, p. 118, Fig. 8.1).

scholarly journals Establishment of the South Korean national antimicrobial resistance surveillance system, Kor-GLASS, in 2016

2018 ◽  
Vol 23 (42) ◽  
Author(s):  
Hyukmin Lee ◽  
Eun-Jeong Yoon ◽  
Dokyun Kim ◽  
Seok Hoon Jeong ◽  
Jong Hee Shin ◽  
...  
Keyword(s):  
Antimicrobial Resistance ◽  
Surveillance System ◽  
Action Plan ◽  
World Health ◽  
Surveillance Systems ◽  
The South ◽  
South Korean ◽  
Antimicrobial Resistance Surveillance ◽  
The Status ◽  
Health Organization

Surveillance plays a pivotal role in overcoming antimicrobial resistance (AMR) in bacterial pathogens, and a variety of surveillance systems have been set up and employed in many countries. In 2015, the World Health Organization launched the Global Antimicrobial Resistance Surveillance System (GLASS) as a part of the global action plan to enhance national and global surveillance and research. The aims of GLASS are to foster development of national surveillance systems and to enable collection, analysis and sharing of standardised, comparable and validated data on AMR between different countries. The South Korean AMR surveillance system, Kor-GLASS, is compatible with the GLASS platform and was established in 2016 and based on the principles of representativeness, specialisation, harmonisation and localisation. In this report, we summarise principles and processes in order to share our experiences with other countries planning to establish a national AMR surveillance system. The pilot operation of Kor-GLASS allowed us to understand the national burden of specific infectious diseases and the status of bacterial AMR. Issues pertaining to high costs and labour-intensive operation were raised during the pilot, and improvements are being made.

scholarly journals Pathways to clean hands: highlights of successful hand hygiene implementation strategies in Europe

2010 ◽  
Vol 15 (18) ◽  
Author(s):  
A P Magiorakos ◽  
E Leens ◽  
V Drouvot ◽  
L May-Michelangeli ◽  
C Reichardt ◽  
...  
Keyword(s):  
Hand Hygiene ◽  
Implementation Strategies ◽  
World Health ◽  
Surveillance Systems ◽  
The European Union ◽  
Hygiene Practices ◽  
Governmental Support ◽  
Hygiene Compliance ◽  
Health Organization ◽  
Healthcare Associated

Hand hygiene is the most effective way to stop the spread of microorganisms and to prevent healthcare-associated infections (HAI). The World Health Organization launched the First Global Patient Safety Challenge - Clean Care is Safer Care - in 2005 with the goal to prevent HAI globally. This year, on 5 May, the WHO’s initiative SAVE LIVES: Clean Your Hands, which focuses on increasing awareness of and improving compliance with hand hygiene practices, celebrated its second global day. In this article, four Member States of the European Union describe strategies that were implemented as part of their national hand hygiene campaigns and were found to be noteworthy. The strategies were: governmental support, the use of indicators for hand hygiene benchmarking, developing national surveillance systems for auditing alcohol-based hand rub consumption, ensuring seamless coordination of processes between health regions in countries with regionalised healthcare systems, implementing the WHO's My Five Moments for Hand Hygiene, and auditing of hand hygiene compliance.

Patient Safety Concerns among Emergency Medical Staff and Patients

2013 ◽  
Vol 1 (1) ◽  
pp. 29-52
Author(s):  
Pi-Fang Hsu ◽  
Wen-Chun Tsai ◽  
Chia-Wen Tsai
Keyword(s):  
Patient Safety ◽  
Emergency Departments ◽  
Medical Staff ◽  
World Health ◽  
The European Union ◽  
Department Of Health ◽  
Perceptions And Attitudes ◽  
The World ◽  
Health Organization

Recently, much of the world, including the World Health Organization, the European Union and many North American countries, have emphasized patient safety. Around the same time, Taiwan’s Department of Health (DOH) devoted a significant amount of resources to better the quality of medical treatment for their patients. This study explores perceptions of and attitudes towards patient safety among medical staff and patients in emergency departments. Analysis results indicate that medical staff and patients significantly differ in perceptions and attitudes. Results of this study provide a valuable reference for governmental authorities and hospital managers in formulating policies aimed at clarifying perceptions and attitudes regarding patient safety among medical staff and patients in emergency departments.

Genetic Material and Sequence Data to Protect Global Health in the Light of Pandemic Outbreaks: Mapping the Legal Landscape under European and International Law

2020 ◽  
Vol 27 (3) ◽  
pp. 232-241
Author(s):  
Claudia Seitz
Keyword(s):  
Global Health ◽  
International Law ◽  
Sequence Data ◽  
Influenza Pandemic ◽  
Genetic Material ◽  
World Health ◽  
The European Union ◽  
Corona Virus ◽  
Health Organization ◽  
The Eu

Abstract The current pandemic outbreak of corona virus SARS-CoV-2 shows the need for comprehensive European cooperation in drug development and the importance of genetic material and sequence data in research concerning this unknown disease. As corona virus SARS-CoV-2 is spreading across Europe and worldwide, national authorities and the European Union (EU) institutions do their utmost to address the pandemic and accelerate innovation to protect global health. In order to be prepared and to be able to respond immediately to serious epidemic and pandemic diseases, the EU has already adopted the Decision No (EU) 1082/2013 on serious cross-border threats to health. The World Health Organization (WHO) has established a global system to collect genetic material and information to protect a global influenza pandemic outbreak. The article describes the current legal landscape under EU and international law.

The Institutional Active Aging Paradigm in Europe (2002–2015)

2019 ◽  
Vol 60 (3) ◽  
pp. 406-415 ◽  
Author(s):  
Raúl López-López ◽  
Mariano Sánchez
Keyword(s):  
World Health ◽  
Critical Examination ◽  
Active Aging ◽  
The European Union ◽  
Reductive Treatment ◽  
Health Organization ◽  
Ideal Framework ◽  
Point Of Departure ◽  
The Eu ◽  
The Ideal

Abstract Background and Objectives The paradigm of active aging has been slowly gaining ground in Europe as the ideal framework for public policy and for responding to the population’s aging. Taking the work by Rune Ervik as its point of departure, this article updates his conclusions on conceptualizations and policies of active aging by performing a study of the institutional discourses in the matter produced by the World Health Organization (WHO), the Organization for Economic Cooperation and Development (OECD), and the European Union (EU). Methods A corpus of 15 WHO, OECD, and EU documents published in the period 2002–2015 and tackling active aging were analyzed qualitatively through a combination of content and thematic analysis, based on a scheme integrated by deductive and inductive iterative manual and computerized codification. Results The institutional discourses on active aging analyzed have not changed dramatically in the period considered. However, a divergent path has emerged regarding the accent placed on participation and contribution in the construction of the paradigm: the more socially productive and health-oriented WHO discourse is slowly separating from the more economically productive and labor-oriented discourses of the EU and OECD. Discussion and Implications The institutional paradigm on active aging is evolving into a reductive treatment of a phenomenon that is multidimensional. International institutions and researchers should pay closer attention and forge a path toward an honest and critical examination of the real conditions and expectations of older people concerning the discursive and practical proposals of active aging, in all its different forms.

MEASUREMENT OF RADON ACTIVITY CONCENTRATION IN UNDERGROUND WATER OF BURETI SUB-COUNTY OF KERICHO COUNTY KENYA

2020 ◽  
Vol 192 (1) ◽  
pp. 56-60
Author(s):  
Charles K Rotich ◽  
Nadir O Hashim ◽  
Margaret W Chege ◽  
Catherine Nyambura
Keyword(s):  
Environmental Protection Agency ◽  
Activity Concentration ◽  
Underground Water ◽  
World Health ◽  
The European Union ◽  
Annual Dose ◽  
Radon Activity ◽  
A Value ◽  
The Us ◽  
Health Organization

Abstract The activity concentration of radon in underground water of Bureti sub-county was measured using liquid scintillating counter device. The average radon activity concentration in all the water samples was 12.41 Bql−1. The maximum and minimum activity concentrations of radon were 22.5 and 4.57 Bql−1, respectively. In total, 53% of the total samples analysed had radon concentration levels above the US Environmental Protection Agency-recommended limit of 11.1 Bql−1. The annual dose received by an individual as a result of waterborne radon was determined according to the United Nations Scientific Committee on the Effect of Atomic Radiation reports and was found to be 33.23 𝜇Svy−1. All the samples recorded a value <100 𝜇Svy−1 recommended by the World Health Organization and the European Union council.

scholarly journals HIV among injecting drug users in Europe: increasing trends in the East

2008 ◽  
Vol 13 (50) ◽  
Author(s):  
L Wiessing ◽  
M J van de Laar ◽  
M C Donoghoe ◽  
B Guarita ◽  
D Klempová ◽  
...  
Keyword(s):  
Drug Users ◽  
Injecting Drug Users ◽  
World Health ◽  
European Region ◽  
Trade Association ◽  
The European Union ◽  
Prevention Measures ◽  
Opioid Substitution Treatment ◽  
Hiv Epidemic ◽  
Health Organization

The human immunodeficiency virus (HIV) epidemic among injecting drug users (IDUs) shows different developments in different parts of the European region. In the countries of the European Union (EU) and the European Free Trade Association (EFTA), the rates of reported newly diagnosed cases of HIV infection in IDUs are mostly at stable and low levels or in decline. In contrast, those rates increased in 2007 in many of the other (eastern) countries in the World Health Organization (WHO) European Region, suggesting that the HIV epidemic among IDUs in Europe is still growing. In countries or regions where indicators of HIV incidence show upward trends, existing prevention measures may be insufficient and in need of strengthening. In the EU/EFTA region the larger availability of harm reduction measures such as opioid substitution treatment and needle and syringe programmes may have played a key role in containing the epidemic among IDUs.

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