Beratung zur Entwicklung von innovativen Arzneimitteln
One of the missions of AGES MEA is to foster the development of safe and efficacious medicinal products. This specifically also extends to supporting the development of innovative medicinal products, that frequently arise from academic groups, start-up companies or small and medium enterprises (SMEs). Medicinal products are considered innovative for example when they are produced via a novel manufacturing process, when they consist of innovative structures or are directed against novel targets; further if they mediated their therapeutic effect via a novel mechanism of action or their method of delivery to the patient had not previously been described. Novel excipients could also qualify in this regard.
The particular need for regulatory and scientific advice for these entities is recognized and supported by AGES MEA (see below).
We provide continued stakeholder information and training with regular events (AGES Gespräch) and participation of our agency in scientific conferences and regulatory trainings.
More detailed information on upcoming events is available on the following websites: www.ages.at/service/ages-akademie/veranstaltungskalender/
Further, the agency regularly publishes on current issues related to the development of medicines. Sign-up to receive these publications and access to the newsletters is available under the following link: www.basg.gv.at/en/news-center/uptodate-newsletter/
Presentations of previous events can be found in the archive, albeit mostly in German:
AGES/BASG Events: www.basg.gv.at/en/news-center/past-events-archive/
AGES Gespräche - www.ages.at/service/ages-akademie/veranstaltungsarchiv/
Further established procedures available to applicants are:
NASA - National scientific advice (http://www.basg.gv.at/en/medicines/prior-to-authorisation/national-scientific-advice/):
The National Scientific advice procedure serves to provide answers to scientific matters regarding the development of medicines based on an applicant’s information provided. The scientific advice procedure is accessible to all applicants, but particularly useful in early development and associated with a fee.
Clinical trial applications (http://www.basg.gv.at/en/medicines/prior-to-authorisation/clinical-trials/):
Detailed information on the conduct of clinical trials is provided in the relevant section of the AGES BASG homepage and the guidance documents are regularly updated.
Compassionate use (http://www.basg.gv.at/en/medicines/prior-to-authorisation/compassionate-use/) :
While Named patient is solely in the responsibility of the treating physician in Austria, Compassionate use as defined in Article 83 of Regulation 726/2004/EC requires agency approval. The procedure facilitates the temporary provision of non-licensed medicinal products to patients for whom no adequate treatment modalities exist and who cannot be included in clinical trials.
Questions on the procedures cited above should be directed to the functional emails associated with these procedures as outlined on the respective webpages.
All other questions, in particular complex questions that relate to the interplay of multiple legal and regulatory frameworks can be addressed to the following e-mail address and will mostly be answered by the same means:
Erstellt am: 27.01.2016