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