Registration authorities, such as the European Medicines Agency or the US Food and Drug Administration, approve the marketing authorization of a biosimilar based on the assumption that the biosimilar generates equivalent outcomes as the reference biopharmaceutical.
According to the German Drug Law [ 20], noninterventional studies conducted after the marketing authorization of a medicinal product have to be notified to the competent authority but are not subject of approval by an ethics committee or an institutional review board if the data collection does not exceed routine medical documentation.
DealBook » Teva's Cephalon Deal Gets Green Light in Europe | The European Commission has given Israel's Teva Pharmaceutical the go-ahead to purchase the American drugmaker Cephalon, provided that Teva sells Cephalon's marketing authorization of sleep disorder drug Modafinil in France.
This study was conducted to provide support for marketing authorization of this drug in China.
There is increasing interest in conducting "Real-World" trials that go beyond traditional assessment of efficacy and safety to examine market access and value for money questions before marketing authorization of a new pharmaceutical product or health technology.
A new generic, once-daily 400-mg tablet of imatinib has been developed by a pharmaceutical company in Argentina, where the regulatory standard for marketing authorization of an imatinib generic is in vitro dissolution testing.
The availability of reliable and relevant ecotoxicity data is a prerequisite for hazard and risk assessment of chemicals in regulatory frameworks, e.g., marketing authorization of plant production products [1], biocides [2], and human pharmaceuticals [3], and within the Water Framework Directive (WFD) [4] and REACH legislations [5].
In October 2012, the European Medicine Agency granted the marketing authorization of alipogene tiparvovec for patients with familial lipoprotein lipase deficiency.
Thus, marketing authorization of a gene therapy medicine in the EU was expected by many to come for some time.
Guidelines on the registration and marketing authorization of biosimilars reflect an increased level of activity and development in this area.
