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. 2013 Jun;24(6):568-70.
doi: 10.1089/hum.2013.101.

From lipoproteins to chondrocytes: a brief summary of the European Medicines Agency's regulatory guidelines for advanced therapy medicinal products

Sadik H Kassim  1 , Robert P T Somerville
Affiliations

From lipoproteins to chondrocytes: a brief summary of the European Medicines Agency's regulatory guidelines for advanced therapy medicinal products

Sadik H Kassim et al. Hum Gene Ther. 2013 Jun.
No abstract available

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Figures

FIG. 1.
FIG. 1.
Committee for Advanced Therapies (CAT) specific involvement in regulation of advanced therapy medicinal products (ATMPs) before submission of a marketing authorization application (MAA). Adapted from European Medicines Agency ([A] and [C]).
FIG. 2.
FIG. 2.
Timeline outlining Committee for Advanced Therapies (CAT) and Committee for Medicinal Products for Human Use (CHMP) specific involvement in regulation of advanced therapy medicinal products (ATMPs) after submission of marketing authorization application (MAA). Adapted from European Medicines Agency ([C]). EC, European Commission; EMA, European Medicines Agency.
See this image and copyright information in PMC

References

    1. European Medicines Agency. [A] Committee for Advanced Therapies—focus on incentives for SMEs and strengthened interaction with stakeholders. www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/02/.... [May;2013 ]. www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/02/...
    1. European Medicines Agency. [B] Committee for Advanced Therapies rules of procedure. www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_.... [May;2013 ]. www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_...
    1. European Medicines Agency. [C] CAT monthly report of application procedures, guidelines and related documents on advanced therapies; April 2013 meeting. www.ema.europa.eu/docs/en_GB/document_library/Committee_meeting_report/2.... [May;2013 ]. www.ema.europa.eu/docs/en_GB/document_library/Committee_meeting_report/2...
    1. European Medicines Agency. [D] Assessment report for Glybera. www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_r.... [May;2013 ]. www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_r...
    1. European Medicines Agency. [E] Assessment report for ChondroCelect. www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_r.... [May;2013 ]. www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_r...

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