Availability of orphan drugs in Europe
The granting of marketing approval does not mean the drug is available throughout all the European countries (list of marketed orphan drugs in Europe). The marketing approval holder must decide beforehand on its commercialisation status within every country and the drug will then go through numerous steps in each country in order to condition its management, and usually its price.
Background: The circadian rhythm regulation plays a crucial role in people`s healthy lives affected by factors consisting of cosmic events related to the universe and earth, environmental factors (light, night and day duration, seasons) and lifestyles. These factors changes lead to disturbance of circadian rhythm and it causes increasing the incidence of mental diseases like depression and physiological problems like cancers, cardiovascular disease and diabetes.
RADOIR NEWS_ Dr. Hamidreza Edraki, Head of Radiology Department of “15 Khordad” hospital stated: “Today, MRI techniques are applied for many common cases, such as diagnosis of the diseases in fetus during pregnancy.
Using MRI during the 1st three months of pregnancy is prohibited, indeed as it can affect embryonic germ cells. Thus, it will be harmless to use MRI, afterwards. Congenital disorders are easily diagnosed by MRI and a team including radiologist, Neurosurgeon, gynecologist will control and manage it during the pregnancy and later on.
Insights into Rare Disease Drug Approval:Trends and Recent Developments Mike Lanthier Operations Research Analyst FDA Office of the Commissioner NORD Rare Diseases & Orphan Products Breakthrough Summit, October 17, 2017
The so-called ‘orphan drugs’ are intended to treat diseases so rare that sponsors are reluctant to develop them under usual marketing conditions.
The process from the discovery of a new molecule to its marketing is long (10 years in average), expensive (several tens of millions of euros) and very uncertain (among ten molecules tested, only one may have a therapeutic effect).
The 2nd award of Corporate Social Responsibility (CSR) was held on 24th July, 2018 with the presence of major domestic companies .
RADOIR News- Corporate Social Responsibility (CSR) is a self-regulating business model that helps a company be socially accountable to itself, its stakeholders, and the public.
The development of orphan drug was incentivized financially in 1983 via the Orphan Drug Act in the US. Before this law, 38 orphan drugs were approved. The Act was then adopted in other markets: in 1993 in Japan and in the European Union in year 2000.
Iran signed the UHC2030 Global Compact and we warmly welcome them to the partnership.
The experience of Iran over past decades and most recently with the Health Transformation Plan (HTP) shows the importance of developing and maintaining health systems with a strong foundation in primary health care and local participatory processes to ensure that health needs are met in an affordable way. The recently-launched National Health Assembly demonstrates the unique role of civil society and community representatives in mobilizing political commitment for universal health coverage (UHC), providing a viable link from local-level to national participation and decision-making.
RADOIR News– To develop the scientific research collaboration on brain disorders, Rare Diseases Foundation of Iran and Iranian National Mapping Lab signed contract agreement on 23th July 2018 .
