Interesting Links to ATMP Pages
Here you get a first overview about the relevant regulatory requirements, regulations, laws as well as competent authorities and organisations in Germany, Europe and US, that are important for ATMPs.
Germany
- PEI, overview of ATMPs
- EPI, ATMP vigilance
- PEI, clinical trials
- PEI, marketing authorisation of human medicinal products
- PEI, approval according to §4b AMG
- German drug and active ingredient manufacturing regulation (AMG)
- §4b Special provisions for advanced therapy medicinal products
EU
- EMA, overview of ATMPs
- EMA, legal framework for ATMPs
- EMA, meetings with stakeholders and other organisations
- EMA, support for ATMP developers
- EMA, certification procedure for micro, small and medium-sized enterprises (SMEs)
- EMA, relevant guidelines for ATMPs
- EMA, ATMP classification
- EMA, summaries of scientific recommendations on ATMP classification
- EMA, marketing authorisation for ATMPs
- EMA, pharmacovigilance for ATMPs
- EMA, committee for advanced therapies (CAT)
- European Commission, overview of ATMPs
- EU GMP Guideline
- Guidelines on good manufacturing practice specific to advanced therapy medicinal products
- Guidelines on good clinical practice specific to advanced therapy medicinal products
USA
- FDA, overview of cellular and gene therapy products
- FDA, guidances to cellular and gene therapy
- FDA, framework for the regulation of regenerative medicine products
- FDA, guidance for industry - potency tests for cellular and gene therapy products
- FDA, guidance for industry - preclinical assessment of investigational cellular and gene therapy products
- FDA, guidance for industry - considerations for the design of early-phase clinical trials of cellular and gene therapy products
