Granting marketing authorisation for medicines in South East European countries: The point of view of the authority

Tomić, Siniša; Sučić, Anita Filipović; Martinac, Adrijana Ilić

doi:10.1016/j.yrtph.2010.04.001

Cited by 5 publications

(3 citation statements)

References 9 publications

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“…Prior to accession candidate EU Member States receive technical support and capacity building in order to harmonise their drug regulation standards with those of the EU. In addition, in the case of Croatia, it was permitted to exchange confidential and safety information with EU regulators and to adopt a simplified recognition procedure for EU market approvals previously granted [ 26 , 27 ]. These measures are described as improving access to medicines in Croatia by increasing the number of medicinal products with market approval in the country “by nearly one-third when Croatia acceded to the EU”; however, it was unclear whether these products were available on the Croatian market [26] .…”

Section: Resultsmentioning

confidence: 99%

Impact of the European Union on access to medicines in low- and middle-income countries: A scoping review

Perehudoff

Durán

Demchenko

et al. 2021

The Lancet Regional Health - Europe

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Summary This Scoping Review synthesises evidence of the impacts of European Union (EU) law, regulation, and policy on access to medicines in in non-EU low- and middle-income countries (LMICs), and the mechanisms and nature of those impacts. We searched eight scholarly databases and grey literature published between 1995-2021 in four languages. The EU exerts global influence on pharmaceuticals in LMICs in three ways: explicit agreements between EU-LMICs (ex. accession, trade, and economic agreements); LMICs' reliance on EU internal regulation, standards, or methods (ex. market authorisation); ‘soft’ forms of EU influence (ex. research funding, capacity building). This study illustrates that EU policy makers adopt measures with the potential to influence medicines in LMICs despite limited evidence of their positive and/or negative impact(s). The EU's fragmented internal and external actions in fields related to pharmaceuticals reveal the need for principles for global equitable access to medicines to guide EU policy.

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Section: Resultsmentioning

confidence: 99%

Impact of the European Union on access to medicines in low- and middle-income countries: A scoping review

Perehudoff

Durán

Demchenko

et al. 2021

The Lancet Regional Health - Europe

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“…Second, regulatory reliance has emerged as a broad concept where a national regulator relies on regulatory decisions taken by a third trusted party [27,28,41], usually a reputed regulator located in another jurisdiction. LA [15] as well as countries in other regions [42][43][44][45] have widely adopted it. Nowadays, several LA countries directly accept or abbreviate the MA process in case of earlier authorization by a designated trusted party, e.g.…”

Section: Plos Onementioning

confidence: 99%

Potential negative impact of reputed regulators’ decisions on the approval status of new cancer drugs in Latin American countries: A descriptive analysis

et al. 2021

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Background Many new cancer drugs are being approved by reputed regulatory authorities without evidence of overall survival benefit, quality of life improvement, and often based on clinical trials at high risk of bias. In recent years, most Latin American (LA) countries have reformed their marketing authorization (MA) rules to directly accept or abbreviate the approval process in case of earlier authorization by the European Medicines Agency (EMA) and the US Food and Drug Administration, mainly. This study assessed the potential impact of decisions taken by EMA regarding the approval of new cancer drugs based on no evidence of overall survival or in potentially biased clinical trials in LA countries. Design Descriptive analysis. Setting Publicly accessible marketing authorization databases from LA regulators, European Public Assessment Report by EMA, and previous studies accessing EMA approvals of new cancer drugs 2009–2016. Main outcome and measures Number of new cancer drugs approved by LA countries without evidence of overall survival (2009–2013), and without at least one clinical trial scored at low risk of bias, or with no trial supporting the marketing authorization at all (2014–2016). Results Argentina, Brazil, Chile, Colombia, Ecuador, Panama and Peru have publicly accessible and trustful MA databases and were included. Of the 17 cancer drugs approved by EMA (2009–2013) without evidence of OS benefit after a postmarketing median time of 5.4 years, 6 LA regulators approved more than 70% of them. Of the 13 drugs approved by EMA (2014–2016), either without supporting trial or with no trial at low risk of bias, Brazil approved 11, Chile 10, Peru 10, Argentina 10, Colombia 9, Ecuador 9, and Panama 8. Conclusions LA countries keep approving new cancer drugs often based on poorly performed clinical trials measuring surrogate endpoints. EMA and other reputed regulators must be aware that their regulatory decisions might directly influence decisions regarding MA, health budgets and patient’s care elsewhere.

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“…Furthermore, each country has regulatory agencies for placing and controlling prescribed medications. Given that some of the countries are small and do not have sufficient capacities, problem with medication control arises after they are placed on the market, especially in Bosnia and Herzegovina and Montenegro ( 12 ).…”

Section: Introductionmentioning

confidence: 99%

Medicine Availability and Prescribing Policy for Non-Communicable Diseases in the Western Balkan Countries

Pekez-Pavliško¹,

Račić

Kusmuk

2017

Front. Public Health

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BackgroundDuring the transition processes, the Western Balkan countries were affected by conflicts and transition-related changes. Life expectancy in these countries is lower, while the mortality from non-communicable diseases (NCDs) is higher in comparison with western and northern parts of Europe. The primary aim of this study was to analyze the treatment possibilities for the most common NCDs in the Western Balkan countries. The secondary aim was to understand and compare the policies regarding prescribing-related competencies of family physicians.MethodsIn June and July 2017, a document analysis was performed of national positive medicines lists, strategic documents, and clinical guidelines for the treatment of the most frequent NCDs; arterial hypertension, diabetes, hyperlipidemia, asthma, and chronic obstructive pulmonary disease (COPD). All text phrases that referred to medicines prescribing were extracted and sorted into following domains: medicine availability, prescribing policy, and medication prescribing-related competencies.ResultsPossibilities for treatment of arterial hypertension, diabetes, hyperlipidemia, asthma, and COPD vary across the Western Balkan countries. This variance is reflected in the number of registered medicines, number of parallels, and number of different combinations, as well as restrictions placed on family physicians in prescribing insulin, inhaled corticosteroids, statins and angiotensin II receptor blockers (ARBs), without consultant’s recommendation.ConclusionWestern Balkan countries are capable of providing essential medicines for the treatment of NCDs, with full or partial reimbursement. There are some exceptions, related to statins, newer generation of oral antidiabetic agents and some of the antihypertensive combinations. Prescribing-related competences of family physicians are limited. However, this practice is not compliant to the practices of family medicine, its principles and primary care structures, and may potentially result in increased health-care financial ramifications to both the system and patients due to frequent referrals to the specialists.

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Granting marketing authorisation for medicines in South East European countries: The point of view of the authority

Cited by 5 publications

References 9 publications

Impact of the European Union on access to medicines in low- and middle-income countries: A scoping review

Impact of the European Union on access to medicines in low- and middle-income countries: A scoping review

Potential negative impact of reputed regulators’ decisions on the approval status of new cancer drugs in Latin American countries: A descriptive analysis

Medicine Availability and Prescribing Policy for Non-Communicable Diseases in the Western Balkan Countries

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