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Advanced Therapy/Cell based Medicinal Products

 
  
In the following you will find a number of regulations applicable to Advanced Therapy/Cell based Medicinal Products
  

European Regulation

  

REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 November 2007 on advanced therapy medicinal products
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:324:0121:0137:en:PDF 

and amending Directive 2001/83/EC
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:311:0067:0128:en:PDF 

and Regulation (EC) No 726/2004
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0001:0033:en:PDF 

COMMISSION DIRECTIVE 2006/86/EC of 24 October 2006
implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation,
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:294:0032:0050:EN:PDF 

COMMISSION DIRECTIVE 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:038:0040:0052:EN:PDF

DIRECTIVE 2004/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:102:0048:0058:EN:PDF 

Procedural advice on the certification of quality and nonclinical data for small and medium sized enterprises developing advanced therapy medicinal products
http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/01/WC500070030.pdf 

“IMPLEMENTATION OF THE 'ADVANCED THERAPIES”
Presentation of Tony Humphries, Croatia 2008. EMEA, Head of Sector Regulatory affairs and Organisational Support (RAOS),
http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2009/11/WC500010332.pdf 

Guideline on the minimum quality and non-clinical data for certification of advanced therapy medicinal products; 15 October 2010, EMA/CAT/486831/2008/corr, Committee for advanced therapies (CAT)
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070031.pdf 

PUBLIC CONSULTATION PAPER ON THE REGULATION ON ADVANCED THERAPY MEDICINAL PRODUCTS, 12/2012
http://ec.europa.eu/health/files/advtherapies/2012_12_12__public_consultation.pdf 

REGULATION (EC) No. 1394/2007 ON ADVANCED THERAPY MEDICINAL PRODUCTS
SUMMARY OF THE RESPONSES TO THE PUBLIC CONSULTATION, 05/2013
http://ec.europa.eu/health/files/advtherapies/2013_05_pc_atmp/2013_04_03_pc_summary.pdf 

Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial October 2005
http://ec.europa.eu/health/files/pharmacos/docs/doc2005/10_05/ca_14-2005_en.pdf 

Implementation of the Advanced Therapies Regulation: Outcome of the Public Consultation on amendments to Annex I to Directive 2001/83/EC
http://ec.europa.eu/health/files/advtherapies/public_consultation_regulation/summary_outcome_2008-07-08_en.pdf 

Implementation of the Advanced Therapies Regulation: Outcome of the Public Consultation on the Certification Of Quality & Non-Clinical Data For Small And Medium-Sized Enterprises
http://ec.europa.eu/health/files/advtherapies/public_consultation_regulation/summary_outcome_2008-07-08_en.pdf 

DRAFT DETAILED GUIDELINE ON GOOD CLINICAL PRACTICE SPECIFIC TO ADVANCED THERAPY MEDICINAL PRODUCTS
http://ec.europa.eu/health/files/advtherapies/docs/2008_07/consultation-paper-nr-2008-07-02_en.pdf 

GUIDELINE ON SAFETY AND EFFICACY FOLLOW-UP - RISK MANAGEMENT OF ADVANCED THERAPY MEDICINAL PRODUCTS
http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500006326.pdf

EMEA-GUIDELINE ON HUMAN CELL-BASED MEDICINAL PRODUCTS
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003898.pdf

EMEA - CPMP/1199/02 Points to Consider on Xenogeneic Cell Therapy Medicinal Products
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003893.pdf 

  

US-American Regulation

  

Guidance for Industry: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Small Entity Compliance Guide
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceCompliance(...)/ucm062592.pdf 

Guidance for Industry :
Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceCompliance(...)/UCM091408.pdf 

COMPLIANCE PROGRAM GUIDANCE MANUAL
Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceCompliance(...)/UCM095216.pdf 

Guidance for Industry Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products – Draft Guidance
http://www.fda.gov/downloads/BiologicsBloodVaccines/(...)/UCM359073.pdf?source=govdelivery

  
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