Dear colleagues! Your opinion, please! What are the ways and opportunities for registering orphan drugs? Thank you in advance for the information. Best regards Olga Shnaybel
Orphan drug. An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases
Now an answer there are international rules that orphan drugs may just register, bu WHO.
Orphan drug. An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases
Now an answer there are international rules that orphan drugs may just register, bu WHO.
Сиротский наркотик . Медикамента является фармацевтическим агентом , разработанным для лечения заболеваний , которые, потому что они настолько редки , не были бы выгодно производить без помощи государства. Условия упоминаются как сиротские заболевания
Olga Shnaybel
Both the modalities and the benefits of registering pharmaceutical products as orphan drugs are provided by national or regional regulations.
Both the US and European legislation aimed primarily at motivating companies in the pharmaceutical industry to invest in R&D of orphan drugs, which because of the very small number of patients were of no interest, being unprofitable in terms of amortizing the investment.
In order to streamline and optimize the efforts of pharmaceutical companies to authorize orphan drugs, in 2007 both agencies, EMA and FDA, standardized the regulations on the application process by an identical procedure.
You may check the EU Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products
A pharmaceutical product designated as orphan drug generates benefits for pharmaceutical companies, such as: marketing exclusivity for 10 years (EU or US market), assistance in obtaining the authorization, reduced fees charged by the EMA for centralized procedures and financing clinical studies.
I published an article on all these aspects, including legislative loophopes, but considering that it is published in Romanian language, its accessibility is reduced.
Thank you very much for your clear and understandable recommendations! I wish you further success! With best wishes Olga Shn
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