Independent regulatory agencies (IRAs) for Health Technology Assessment (HTA) are a key means by which national governments have responded to the challenge of ensuring equitable public access to a new range of medicines and treatment options within the context of limited national budgets for healthcare. In this paper, we apply a regulatory governance frame to the study of the Swedish process fo...

The term ‘regulatory state’ entered the vocabulary of students of European Politics over twelve years ago with the publication, in West European Politics, of Giandomenico Majone’s seminal ‘The rise of the regulatory state in Europe’ (Majone 1994). Underlying Majone’s argument was the diagnosis of two key trends, one being an overall shift towards the use of legal authority or regulation over th...

BACKGROUND Previous evaluations of oncological medicines in the German early benefit assessment (EBA) procedure have demonstrated inconsistent acceptance of endpoints by regulatory authorities and the Federal Joint Committee (G-BA). Accepted standard endpoints for regulatory purposes are frequently not considered as patient-relevant in the German EBA system. In this study the acceptance of clin...

OBJECTIVE The Health and Social Care Act 2012 ('HSCA 2012') introduced a new, statutory, form of regulation of competition into the National Health Service (NHS), while at the same time recognising that cooperation was necessary. NHS England's policy document, The Five Year Forward View ('5YFV') of 2014 placed less emphasis on competition without altering the legislation. We explored how commis...

BACKGROUND Medical devices and in vitro diagnostic tests (IVD) are vital components of health delivery systems but access to these important tools is often limited in Africa. The regulation of health commodities by National Regulatory Authorities is intended to ensure their safety and quality whilst ensuring timely access to beneficial new products. Streamlining and harmonizing regulatory proce...

The experience of low- and middle-income countries (LMC) with respect to regulation and legislation in the health sector is in marked contrast to that of Canada and Europe. It is suggested that the degree to which regulatory mechanisms can influence private sector activity in LMC is quite low. However, there has been little work done on exploring just how, and to what extent, these regulations ...

background pharmacovigilance (pv) data are crucial for ensuring safety and effectiveness of medicines after drugs have been granted marketing approval. this paper describes the pv systems of india, uganda and south africa based on literature and key informant (ki) interviews and compares them with the world health organization’s (who’s) minimum pv requirements for a functional national pv syste...

glimepiride/metformin(2/500mg) is an oral antihyperglycemic agent for the treatment of type 2 diabetes. a generic glimepiride/metformin(2/500mg) fixed-dose combination(fdc) tablet was developed recently. this study was designed to collect data for submission to korean regulatory authorities to allow the marketing of the test formulation. we evaluated the comparative bioavailability and tolerabi...