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 ON ADVANCED THERAPY MEDICINAL PRODUCTS SUMMARY OF THE RESPONSES TO THE PUBLIC CONSULTATION, 05/2013 (151.1 kB)
- and amending Directive 2001/83/EC (365.8 kB)
- and Regulation (EC) No 726/2004 (253.5 kB)
- 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, (161.4 kB)
- 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 (83.4 kB)
- 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 (242.2 kB)
- Procedural advice on the certification of quality and nonclinical data for small and medium sized enterprises developing advanced therapy medicinal products (130.5 kB)
- “IMPLEMENTATION OF THE 'ADVANCED THERAPIES” Presentation of Tony Humphries, Croatia 2008. EMEA, Head of Sector Regulatory affairs and Organisational Support (RAOS), (1.2 MB)
- 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) (132.5 kB)
- PUBLIC CONSULTATION PAPER ON THE REGULATION ON ADVANCED THERAPY MEDICINAL PRODUCTS, 12/2012 (38.0 kB)
- REGULATION (EC) No. 1394/2007 ON ADVANCED THERAPY MEDICINAL PRODUCTS SUMMARY OF THE RESPONSES TO THE PUBLIC CONSULTATION, 05/2013 (91.6 kB)
- 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 (293.7 kB)
- Implementation of the Advanced Therapies Regulation: Outcome of the Public Consultation on amendments to Annex I to Directive 2001/83/EC (26.2 kB)
- DRAFT DETAILED GUIDELINE ON GOOD CLINICAL PRACTICE SPECIFIC TO ADVANCED THERAPY MEDICINAL PRODUCTS (68.8 kB)
- GUIDELINE ON SAFETY AND EFFICACY FOLLOW-UP - RISK MANAGEMENT OF ADVANCED THERAPY MEDICINAL PRODUCTS (206.7 kB)
- EMEA-GUIDELINE ON HUMAN CELL-BASED MEDICINAL PRODUCTS (205.1 kB)
- EMEA - CPMP/1199/02 Points to Consider on Xenogeneic Cell Therapy Medicinal Products (298.4 kB)
US-American Regulation
- Guidance for Industry: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Small Entity Compliance Guide (91.2 kB)
- 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) (325.1 kB)
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
- Good Distribution Practice
- Sterile Manufacturing
- Computer Validation
- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- Impurities
- OOS / OOE / OOT
- Material Testing
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Microbiological Testing
- Technology
- General Manufacturing Topics
- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others