Introduction of the new drug on the market: How do you enter the market?
After registration of Nervarin® ( salizumab) the drug needs to enter the market. To enter market successfully different stakeholders need to be addressed and informed about Nervarin. Nervarin will be distributed all over the world, but the drug for RRMS will be launched in Europe. Different marketing strategies will be handled
Introducing Nervarin to the market
To assure the drugs gets to the patient, a marketing authorization application has to be requested at the EMA. An universal trade authorization for Europe is requested. The authorization is provided by the European committee. Nervarin will be distributed throughout …show more content…
Adverse drug reactions (ADRs) are ranked as one of the top ten causes of morbidity and mortality in the developed world; they are the third leading cause of death after heart disease and cancer. In the United States of America, ADRs claim 218 000 lives annually and 197 000 in the European Union (EU) (JE Campbell, 2015) (Santoro & Genov, …show more content…
What is pharmacovigilance
According to the world health organization (WHO) pharmacovigilance is: ‘The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem’ (World Health Organization, n.d.).
The aim of pharmacovigilance is to improve patient care and patient safety in relation to the use of medicines; it is also to support public health programs by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines and the minimization of risk.
Pharmacovigilance is to make sure medication is used safe and effective by:
• promoting the detection of previously unknown ADRs and interactions
• identifying risk factors for the development of ADRs
• disseminating information about ADRs to improve drug prescribing and regulation
• educating and informing