beeldscherm schreef op 30 oktober 2017 15:09:
dit gaat ook nog een positieve rol voor pharmings ruconest betekenen maar dan in China.
China Issues New Policy for Drug and Medical Device Approvals
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Acceleration of review and approval process
The Opinion provides for special fast-track approval for two kinds of drugs and medical devices: (i) new drugs and devices in urgent clinical need; and (ii) drugs and devices for rare diseases. The new drug or device in urgent clinical need can be approved for marketing with conditions if the data in early or mid-stage trials shows its clinical value. The drug or device for rare diseases can be approved for marketing with conditions if it has been approved for marketing overseas. In addition, new drugs and devices in urgent clinical need which are major national science and technology projects and financed by key national development plans, as well as those recognized by the relevant departments and with clinical trials conducted in national clinical research centers will be given priority in the review and approval process.
Please note that approval of injectable drug products will be strictly controlled.
"The drug or device for rare diseases can be approved for marketing with conditions if it has been approved for marketing overseas"
www.lexology.com/library/detail.aspx?...maw het word makkelijker om de chinese markt te betreden als een product al positieve trials heeft gedaan in het buitenland