Search results for "medicinal product"
showing 5 items of 5 documents
The European regulatory environment of rna-based vaccines
2016
A variety of different mRNA-based drugs are currently in development. This became possible, since major breakthroughs in RNA research during the last decades allowed impressive improvements of translation, stability and delivery of mRNA. This article focuses on antigen-encoding RNA-based vaccines that are either directed against tumors or pathogens. mRNA-encoded vaccines are developed both for preventive or therapeutic purposes. Most mRNA-based vaccines are directly administered to patients. Alternatively, primary autologous cells from cancer patients are modified ex vivo by the use of mRNA and then are adoptively transferred to patients. In the EU no regulatory guidelines presently exist t…
Development of extracellular vesicle-based medicinal products: A position paper of the group “Extracellular Vesicle translatiOn to clinicaL perspecti…
2021
International audience; Extracellular vesicles (EV) are emergent therapeutic effectors that have reached clinical trial investigation. To translate EV-based therapeutic to clinic, the challenge is to demonstrate quality, safety, and efficacy, as required for any medicinal product. EV research translation into medicinal products is an exciting and challenging perspective. Recent papers, provide important guidance on regulatory aspects of pharmaceutical development, defining EVs for therapeutic applications and critical considerations for the development of potency tests. In addition, the ISEV Task Force on Regulatory Affairs and Clinical Use of EV-based Therapeutics as well as the Exosomes C…
Cell therapy medicinal product regulatory framework in Europe and its application for MSC-based therapy development
2012
Advanced therapy medicinal products (ATMPs), including cell therapy products, form a new class of medicines in the European Union. Since the ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for these medicines and implemented from 2009. The Committee for Advanced Therapies (CAT) has been established at the European Medicines Agency (EMA) for centralized classification, certification and evaluation procedures, and other ATMP-related tasks. Guidance documents, initiatives, and interaction platforms are available to make the new framework more accessible for small- and medium-sized enterprises, academia, hospitals, and foundation…
Spectral characteristics of 5-hydroxymethylfurfural as a related substance in medicinal products containing glucose
2019
Objectives: To study 5-hydroxymethylfurfural (5-HMF) spectral characteristics aiming at their future application in analytical procedures and their validation for the determination of 5-HMF in liquid products containing glucose after sterilization.Method: Direct spectrophotometric method for the determination of 5-HMF using the molar absorption coefficient at the absorption maximum (284 nm).Results and discussion: aqueous 5-HMF solutions have strong absorption in the ultraviolet range below 310 nm and give two absorption maxima at wavelengths of 229–230 nm and 284 nm. An excellent linear relationship between absorbance and 5-HMF concentration was observed in the concentration range of 2.0–1…
Prawne aspekty prowadzenia apteki internetowej jako elementu rynku e-health
2018
Wykorzystanie nowoczesnych technologii informatycznych jest elementem rozwojowym rynku farmaceutycznego, a sprzedaż internetowa stanowi interesujący kanał dystrybucji produktów leczniczych. Termin „apteka internetowa” nie posiada swojej definicji legalnej w polskim prawie. Jest on jednak powszechnie stosowany dla określenia aptek ogólnodostępnych i punktów aptecznych, które za pomocą Internetu prowadzą działalność polegającą na sprzedaży wysyłkowej produktów leczniczych. Możliwość ta dotyczy wyłącznie leków dostępnych bez recepty. Kluczowe znaczenie dla prezentowanej problematyki ma pojęcie sprzedaży wysyłkowej. Prowadzenie działalności z zakresu sprzedaży produktów leczniczych, również na …