From lipoproteins to chondrocytes: A brief summary of the european medicines agency's regulatory guidelines for advanced therapy medicinal products

Human Gene Therapy

Volumn 24, Issue 6, 2013, Pages 568-570

  Kassim, Sadik H ^a   Somerville, Robert P T ^a  

^a NATIONAL CANCER INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALIPOGENE TIPARVOVEC; CHONDROCYTE IMPLANT; LIPOPROTEIN; PARVOVIRUS VECTOR;

CARTILAGE CELL; CELL TRANSPLANTATION; CERTIFICATION; CLASSIFICATION; DRUG INDUSTRY; EUROPEAN UNION; GENE MUTATION; GOVERNMENT REGULATION; HUMAN; HYPERLIPOPROTEINEMIA TYPE 1; MARKETING; NONHUMAN; NOTE; PRACTICE GUIDELINE; TISSUE ENGINEERING;

CHONDROCYTES; DRUG INDUSTRY; EUROPE; EUROPEAN UNION; GUIDELINES AS TOPIC; HUMANS; LEGISLATION, DRUG; LIPOPROTEINS;

EID: 84879182522     PISSN: 10430342     EISSN: 15577422     Source Type: Journal    
DOI: 10.1089/hum.2013.101     Document Type: Note

References (7)

1. European Medicines Agency. [A] Committee for Advanced Therapies-focus on incentives for SMEs and strengthened interaction with stakeholders. Available at www.ema.europa .eu/ema/index.jsp?curl=pages/news-and-events/news/2013/02/news- detail-001717.jsp&mid=WC0b01ac058004d5c1 (accessed May 2013).
2. European Medicines Agency. [B] Committee for Advanced Therapies rules of procedure. Available at www.ema.europa .eu/docs/en-GB/document-library/ Regulatory-and-procedural-guideline/2009/10/WC500004761.pdf (accessed May 2013).
3. European Medicines Agency. [C] CAT monthly report of application procedures, guidelines and related documents on advanced therapies; April 2013 meeting. Available at www .ema.europa.eu/docs/en-GB/document-library/Committee- meeting-report/2013/04/WC500142879.pdf (accessed May 2013).
4. European Medicines Agency. [D] Assessment report for Glybera. Available at www.ema.europa.eu/docs/en-GB/document-library/EPAR-Public-assessment-report/ human/002145/WC500135476.pdf (accessed May 2013).
5. European Medicines Agency. [E] Assessment report for ChondroCelect. Available at www.ema.europa.eu/docs/en-GB/document-library/EPAR-Public- assessment-report/human/000878/WC500026035.pdf (accessed May 2013).
6. European Medicines Agency. [F] MACI (matrix applied characterized autologous cultured chondrocytes): Summary of opinion. Available at www.ema.europa.eu/docs/en-GB/document-library/Summary-of-opinion-Initial- authorisation/human/002522/WC500142496.pdf (accessed May 2013).
7. Maciulaitis, R., D'Apote, L., Buchanan, A., et al. (2012). Clinical development of advanced therapy medicinal products in Europe: Evidence that regulators must be proactive. Mol. Ther. 20, 479-482.