Search for EMA regulatory support schemes

Search results

1. “Compassionate use” and “named-patients basis” pathways for ATMPs

   … National competent authorities can ask the EMA for a CHMP recommendation on how to use a medicine under … 1. To identify and implement the applicable National regulatory framework 2. To contact and interact with the National competent authority to find support for 1. …

2. Standard Marketing Authorisation Pathway: Centralised Procedure for ATMPs

   … in the European Union. European Medicines Agency (EMA):  Under the centralised procedure, companies submit … the European Union. [Source: EMA  Glossary of regulatory terms ] Clock stop: A period of … Early interactions with regulators  Support for innovative medicines’ development , …

3. Support for innovative medicines’ development at the EMA level

   Support for innovative medicines’ development at the EMA … pharmaceutical legislation. Therefore, the services and regulatory procedures designed to establish an early contact …

4. Commercialisation Resources

   … Post-A uthorisation scientific and regulatory guidance for all products types ,  European Medicines Agency (EMA)​​​​​​ EU market access roadmaps … products, European Commission (EC) EMA regulatory support schemes   PRIME  PRIME: priority …

5. Procédure centralisée pour les médicaments de thérapie innovante

   … Agence européenne des médicaments  (abrégée   EMA   provenant de l’anglais ‘ European Medicines … ATMPs Accelerated Assessment of ATMPs EMA regulatory support schemes La décision finale et …

6. Support specific to ATMPs’ development at EMA level

   Support specific to ATMPs’ development at EMA level … ATMPs). (Completed and adapted from  EMA Glossary of regulatory terms )  ATMP certification : The …

7. Commercialisation Binding Texts and Guidance

   … centralized procedure    GUIDELINES   EMA, Procedural advice on the evaluation of ATMPs , … 1996 EMA, CPMP, ICH E4 Dose response information to support drug registration , CPMP/ICH/378/95, November 1994 … other relevant guidelines for biosimilars EMA regulatory support schemes     PRIME    …

8. Commercialisation

   … Marketing Authorisation (MA) granted by a medicines regulatory agency. MA is the key milestone in a medicine’s … Application (MAA) to the European Medicines Agency (EMA). EMA's Committee for Medicinal products for Human … is unethical EMA has also established regulatory support schemes for innovative medicines, including ATMPs: …

9. EMA tools for academic medicine developers

   EMA tools for academic medicine developers EMA provides regulatory and scientific support to developers from the academic sector to foster …

10. Research Pathways

    … Pathways is centred around the legal and regulatory aspects for cell and gene therapy development in … the industry-scale production of these therapies for supporting clinical development and commercialisation. This … Sostegno allo sviluppo di farmaci innovativi a livello EMA EU and UK …