OCT is excited to announce that we have been granted with a very interesting project recently, which is going to be orphan drug registration for a European company. This process will be conducted from one of OCT’s Baltic States office, reason being since this orphan drug is going to be registered in Europe through the EEA and will also be coinciding with the SME regulations set forth by the EMA. In order for a medicine to qualify into orphan status it must one of the follow two criteria, it must be intended for the prevention, diagnosis, and or treatment of a chronically debilitating or life threatening condition affecting no more than 5 in 10,000 people in the EU at the current time of the submission of the designation application. The other one is it is intended for prevention, treatment of life threatening conditions, and without incentives it is unlikely that the revenue after the marketing of the medicinal product would cover the initial investment in its development.
There are multiple procedures which have to be take care in order for this orphan drug status to be reached by OCT. Since this company that OCT is representing is not in the Europe Union orphan drug status regulations require them to have some kind of presence in the EU. One of the regulations is that establishment in the EEA is required pursuant to Article 2.1 of Regulation 2049/2005. For non- EEA companies there are a couple ways to access the incentives in these regulations, one being to apply once the company has established a subsidiary in the EEA. Another way to apply for the orphan drug status registration is through an EU established regulatory consultancy. In this case OCT is that regulatory consultancy that will represent the Sponsor throughout this process of the registration procedures.
OCT is always trying to expand, this project will only add to that process with new business and services. This is the advantage of OCT because we have so many different offices we cover a very large area of CEE, CIS, and Russia we can accommodate a Sponsor’s business often in an area that they didn’t think was an option. OCT hopes that in the future there will be more contracts similar to this one so we can continue to expand our horizons. OCT is doing everything in our power to expedite the process of this orphan drug status registration for our Sponsor.