scholarly journals Comparison Review of Two Regulatory Agencies Regulation: Therapeutic Goods Administration (TGA) and the European Medicine Agency (EMA) in Relation to Good Manufacturing Practice (GMP) Guideline

2021 ◽  
Vol 17 (2) ◽  
pp. 243
Author(s):  
Farida Aziza
Keyword(s):  
Pharmaceutical Industry ◽  
Legal Status ◽  
Primary Source ◽  
High Standard ◽  
Product Distribution ◽  
Good Manufacturing Practice ◽  
Regulatory Agencies ◽  
European Medicines Agency ◽  
Regulatory Body ◽  
Regulatory Bodies

There are some regulatory bodies in the world that impacting the pharmaceutical industry to operate and perform Good Manufacturing Practice (GMP) principles. These regulatory bodies exist to ensure that the pharmaceutical product and other human supporting products have a high standard of quality, safety, and efficacy from product registration to product distribution to the patient. This article reviews some aspects which is regulated by two of regulatory entities including Therapeutic Goods Administration (TGA) and European Medicines Agency (EMA) in relation with Good Manufacturing Practice (GMP) principles. The GMP principles which is structured by these regulatory agencies may be originally created by the agencies or influenced by other regulatory body concepts. The guidance can be a primary source or second reference for the pharmaceutical industry in impacting countries depending on the guideline’s legal status. It is noticeable that both regulatory bodies have some similar concepts to support GMP implementation and some differentt practices which may be considered by the pharmaceutical industry when it is aimed to market their product in the regulated countries. 

Activities of the Eurasian Economic Commission as the Main Regulatory Body of the Eurasian Economic Union

2020 ◽  
Vol 17 (4) ◽  
pp. 25-30
Author(s):  
Dmitriy V. Galushko
Keyword(s):  
Regional Integration ◽  
Legal Status ◽  
Regulatory Body ◽  
Scientific Methods ◽  
Eurasian Economic Union ◽  
Economic Commission ◽  
Regulatory Bodies ◽  
General Scientific ◽  
Economic Union ◽  
National Competent Authorities

Introduction. One of the most important aspects of the functioning of modern regional international integration organizations is the activity of their executive and regulatory bodies in cooperation with national competent authorities. This is especially relevant in the process of the functioning of the Eurasian Economic Union and the development of the legal order of this integration association. Purpose. The purpose of the study is to study and analyze the most important aspects of the activities of the Eurasian economic Commission in the context of interaction with national regulatory authorities. Methodology. The study used both General scientific methods of cognition - analysis, synthesis, induction, deduction, comparison, and private law methods (formal legal, technical-legal, and the method of legal analogy). Results. The article reveals the specifics of the legal status of the Eurasian Economic Commission as the main regulatory body of the Eurasian Economic Union, its specificity in the context of a set of supranational powers, largely due to which the integration processes within the Union are developing. Conclusion. The conclusions made as a result of the study can be used in relation to the improvement and development of the legal systems of international organizations of regional integration with the participation of the Russian Federation, in particular, the Eurasian Economic Union, as well as the process of interaction of national government bodies with the Eurasian Economic Commission.

Alternativas farmacéuticas: ¿pueden ser intercambiables?

2020 ◽  
Vol 2 (2) ◽  
pp. 38-42
Author(s):  
Miriam del Carmen Carrasco-Portugal ◽  
Francisco Javier Flores-Murrieta
Keyword(s):  
Generic Substitution ◽  
In Vivo Studies ◽  
Regulatory Agencies ◽  
European Medicines Agency ◽  
Reference Formulation ◽  
Active Moiety ◽  
Significant Difference ◽  
Pharmaceutical Form ◽  
Extent Of Absorption

Pharmaceutical alternatives are products with the same active moiety, but different salt, ester or pharmaceutical form. Regulatory agencies have different criteria for this kind of drug. The European Medicines Agency (EMA) accepts the generic substitution using these alternatives, whereas the Food and Drug Administration (FDA) only authorizes generic substitution of pharmaceutical equivalents. The objective of this paper is to describe some relevant aspects that should be considered before deciding on making a generic substitution with pharmaceutical alternatives. It is important to note that a pharmaceutical alternative must show no significant difference in the rate and extent of absorption (bioequivalence) in a well-conducted in vivo study when compared with the reference formulation. Current Mexican regulations state that generic substitution is possible using pharmaceutical alternatives when bioequivalence is demonstrated in in vivo studies conducted under the NOM-177-SSA1-2013 criteria. In conclusion, generic substitution with pharmaceutical alternatives is possible if these products demonstrate in vivo bioequivalence when compared with the reference product.

scholarly journals Reporting of harms in oncological clinical study reports submitted to the European Medicines Agency compared to trial registries and publications—a methodological review

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Asger S. Paludan-Müller ◽  
Perrine Créquit ◽  
Isabelle Boutron
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Study ◽  
Primary Source ◽  
European Medicines Agency ◽  
Clinical Trial Registries ◽  
Number Of Patients ◽  
Journal Publications ◽  
Clinical Study Reports ◽  
Completeness Of Reporting

Abstract Background An accurate and comprehensive assessment of harms is a fundamental part of an accurate weighing of benefits and harms of an intervention when making treatment decisions; however, harms are known to be underreported in journal publications. Therefore, we sought to compare the completeness of reporting of harm data, discrepancies in harm data reported, and the delay to access results of oncological clinical trials between three sources: clinical study reports (CSRs), clinical trial registries and journal publications. Methods We used the EMA clinical data website to identify all trials submitted to the EMA between 2015 and 2018. We retrieved all CSRs and included all phase II, II/III or III randomised controlled trials (RCTs) assessing targeted therapy and immunotherapy for cancer. We then identified related records in clinical trial registries and journals. We extracted harms data for eight pre-specified variables and determined the completeness of reporting of harm data in each of the three sources. Results We identified 42 RCTs evaluating 13 different drugs. Results were available on the EMA website in CSRs for 37 (88%) RCTs, ClinicalTrials.gov for 36 (86%), the European Clinical Trials Register (EUCTR) for 20 (48%) and in journal publications for 32 (76%). Harms reporting was more complete in CSRs than other sources. We identified marked discrepancies in harms data between sources, e.g. the number of patients discontinuing due to adverse events differed in CSRs and clinical trial registers for 88% of trials with data in both sources. For CSRs and publications, the corresponding number was 90%. The median (interquartile range) delay between the primary trial completion date and access to results was 4.34 (3.09–7.22) years for CSRs, 2.94 (1.16–4.52) years for ClinicalTrials.gov, 5.39 (4.18–7.33) years for EUCTR and 2.15 (0.64–5.04) years for publications. Conclusions Harms of recently approved oncological drugs were reported more frequently and in more detail in CSRs than in trial registries and journal publications. Systematic reviews seeking to address harms of oncological treatments should ideally use CSRs as the primary source of data; however, due to problems with access, this is currently not feasible.

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.

scholarly journals INTERNATIONAL EXPERIENCE OF PUBLIC ADMINISTRATION OF PRODUCTION AND TURNOVER OF MEDICINES IN UKRAINE

2020 ◽  
pp. 151-159
Author(s):  
Л. В. Котенко
Keyword(s):  
Health Care ◽  
Life Expectancy ◽  
Public Administration ◽  
International Cooperation ◽  
International Organizations ◽  
Good Manufacturing Practice ◽  
International Experience ◽  
Iso 9001 ◽  
Regulatory Bodies

The article forms the international experience of public administration of production and circulation of medicines in Ukraine. The role of international organizations in maintaining the health of the nation, increasing the level of labor productivity, as well as the quality and life expectancy of people is studied. The leaders of the European market of drug manufacturers have been identified. The international standard ISO 9001 and features of introduction of good manufacturing practice (GMP) are analyzed. The international cooperation for the regulatory bodies of the WHO member states is described in order to discuss ways to strengthen cooperation in the field of health care.

scholarly journals Trends in the costs of drugs launched in the UK between 1981 and 2015: an analysis of the launch price of drugs in five disease areas

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e027625 ◽  
Author(s):  
Derek J Ward ◽  
Lucy Doos ◽  
Andrew Stevens
Keyword(s):  
Colorectal Cancer ◽  
Cross Sectional Study ◽  
New Drugs ◽  
Regulatory Agencies ◽  
European Medicines Agency ◽  
Biological Drugs ◽  
Cross Sectional ◽  
Medical Benefits ◽  
Using Data ◽  
The Uk

ObjectivesTo investigate the trend in the launch price of new drugs for five common health conditions.DesignCross-sectional study using data on new drugs launched in the UK between 1981 and 2015 for hypertension, asthma, rheumatoid arthritis, schizophrenia and colorectal cancer.Data and sourcesAll drugs marketed in the UK between 1981 and 2015 (inclusive), and licensed specifically for the treatment of one of the five chosen conditions were included in the study. Newly launched medicines and their launch prices were identified by hand-searching all editions of the British National Formulary in addition to searching the websites of relevant regulatory agencies (European Medicines Agency and Medicines and Healthcare products Regulatory Agency). The launch price in UK pounds for a 28-day supply of each medicine at a typical or usual maintenance dose was adjusted for the effects of general inflation using the gross domestic product deflator series.Results104 drugs were included in our study with a mean inflation-adjusted 28-day launch price of £288 (SD £678). The launch price of new drugs varied significantly across the five conditions, with drugs for hypertension having the lowest mean price (£27) and drugs for colorectal cancer having the highest mean price (£1590) (p<0.001). There were large increases in launch prices across the study period, but the magnitude and pattern was markedly different between therapeutic areas. Biological drugs represented 13.5% of all included drugs and had a significantly higher launch price than non- biological drugs (£1233 vs £141, p<0.001). 22.1% of included drugs were first-of-kind and had a significantly higher launch price than follow-on drugs (£768 vs £151) (p<0.0001).ConclusionDrugs prices continue to increase across different therapeutic areas. This has some association with novelty, but, it is not clear if this increase in price is associated with medical benefits.

VoIP Based Tele-medicine Call Center–Issues, Challenges and Proposed Solution

2015 ◽  
Vol 74 (1) ◽  
Author(s):  
Ishtiak Al Mamoon ◽  
A. K. M Muzahidul Islam ◽  
Sabariah Baharun
Keyword(s):  
Call Center ◽  
Regulatory Authority ◽  
Pilot Project ◽  
Regulatory Body ◽  
Test Bed ◽  
Ip Telephony ◽  
Telecommunication Sector ◽  
Regulatory Bodies ◽  
Two Phases ◽  
The Voice

In recent years, medical call centers have started using IP telephony services to minimize the overhead telecom expenses. However, the advent of Voice-Over-IP (VoIP) technology has also created a major discontinuity in telecommunication sector due to illegal VoIP or gray calls, causing a great impact on the voice market. This brought few challenges to the countries’ regulatory bodies. In this paper, we spell out one of the key challenges: in order to mitigate illegal VoIP calls, whether the regulatory body should allow IP telephony to be practiced for both domestic and international voice driven tele-medical consultation  center operation combined or separately. We propose architecture and schemes for a medical call center. We also propose some guidelines and/or policies for both call center operator and the telecom regulatory authority. The proposed architecture and schemes are implemented in a pilot project basis in two phases and the test bed result is presented in this article.

Pharmaceutical Regulation in the European Union

2018 ◽  
Author(s):  
Stuart O. Schweitzer ◽  
Z. John Lu
Keyword(s):  
European Union ◽  
Drug Approval ◽  
Good Clinical Practice ◽  
The United States ◽  
Good Manufacturing Practice ◽  
Pharmaceutical Products ◽  
European Medicines Agency ◽  
Regulatory Regime ◽  
The European Union ◽  
Regulatory Pathways

The main scientific and technical aspects of new drug registration, including pathways to marketing authorization approval, clinical study design and method, and requirement of and specifications for Good Clinical Practice, Good Laboratory Practice, and Good Manufacturing Practice, are all quite similar between Europe and the United States. Differences do exist, however. This chapter provides a closer examination of the drug regulatory regime in the European Union. After providing a brief history of the European Medicines Agency, the chapter examines the agency’s organizational structure and role in ensuring the safety and efficacy of pharmaceutical products for Europe, and discusses the regulatory pathways for generics and biosimilars in the EU. The chapter also looks at recent trends in international drug approval lags.

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.

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