regulatory approach Medical Devices Medicinal Products 2001/83/EC Advanced Therapies Legislation Science Tissue Engineering Medical Devices

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2 regulatory approach Legislation Medical Devices 93/42/EEC? Medicinal Products 2001/83/EC Science Advanced Therapies Medical Devices Tissue Engineering Cell Therapy Gene Therapy Biotech Chemicals By N. Rossignol

3 autologous products allogeneic products Ref. : Joint Research Centre, European Commission, 2003 (see also impact assessment of the proposal)

4 Tissue-Engineering & Advanced Therapies Regulation 1394/2007

5 Specific rules regarding the authorization, supervision and pharmacovigilance of advanced therapy medicinal products (ATMPs)

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13 e.g. expansión e.g. cambio de localización DEBE CUMPLIR LA LEGISLACIÓN DE MEDICAMENTOS

14 DEBE CUMPLIR LA LEGISLACIÓN DE MEDICAMENTOS necesita autorización de uso: comercialización, investigación clínica, uso compasivo garantías sobre su calidad, seguridad, eficacia GMP (producción y control), GLP (estudios no clínicos) y GCP (ensayos clínicos) son aplicables investigación clínica, uso compasivo autorización por cláusula de exclusión autorización de comercialización en la UE

15 For products within the scope: Marketing authorisation required Demonstration of Quality, Safety & Efficacy Post-authorisation vigilance of S & E Centralised procedure mandatory

16 Advanced therapy medicinal products which are intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process (Title II of Directive 2001/83).

17 EXCLUDED from the scope of this Regulation: advanced therapy medicinal products which are prepared on a non-routine basis according to specific quality standards, used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner in order to comply with an individual medical prescription for a custom-made product for an individual patient

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19 5 CHMP members (co-opted or not) with their alternates 1 M (1A) per member state from those not represented through CHMP 2 M (2A) representing clinicians 2 M (2A) representing patients associations Should include at least 2 M (2A) with expertise in medical devices Members expertise: medical devices, tissue engineering, gene/cell therapy, biotechnology, surgery, pharmacovigilance, risk management and ethics

20 COMITÉS CIENTÍFICOS CHMP CVMP COMP HMPC

21 CHMP COMITÉS CIENTÍFICOS

22 ChondroCelect (autologous chondrocytes): marketing authorization granted (July 2009) Cerepro (AdV-HSVtk): withdrawn by the applicant before the final negative opinion on the second application Advexin (AdV-p53): withdrawn by the applicant before the final negative opinion Glybera (AAV-LPL): negative opinion after re-examination

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25 CHAPTER 2 MARKETING AUTHORISATION REQUIREMENTS Article 3. Donation, procurement and testing Where an advanced therapy medicinal product contains human cells or tissues, the donation, procurement and testing of those cells or tissues shall be made in accordance with Directive 2004/23/EC. Article 4. Clinical trials 1. The rules set out in Article 6(7) and Article 9(4) and (6) of Directive 2001/20/EC in respect of gene therapy and somatic cell therapy medicinal products shall apply to tissue engineered products. 2. The Commission shall, after consulting the Agency, draw up detailed guidelines on good clinical practice specific to advanced therapy medicinal products. Article 5. Good manufacturing practice The Commission shall, after consulting the Agency, draw up guidelines in line with the principles of good manufacturing practice and specific to advanced therapy medicinal products.

26 Post-authorisation requirements Follow-up of efficacy and adverse reactions, and risk management: EMEA shall inform the relevant national competent authorities Patient and product traceability (hospital, institution)

27 Scientific Advice: 90% fee reduction for SMEs, 65% for others No limit in time Scientific recommendation on advanced therapy classification: 60 days

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30 Regulation applicable since the end of 2008 Transitional period: gene therapy and cell therapy products: 3 years (till ) tissue engineered products: 4 years ( ) During transitional period, no marketing authorization fee for upgrade of products authorized at the national level Reporting 5 years after entry into force

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32 MARCO LEGAL NACIONAL Investigación clínica con medicamentos (necesita calificación de PEI) Evaluación del Riesgo Ambiental (si OMG) OMG: organismo en el que el material genético ha sido alterado de forma tal que no se obtiene en la naturaleza por apareamiento o recombinación natural. * PEI: Producto en fase de investigación (IMP, IND)

33 PROCEDIMIENTO de EVALUACION Evaluación del protocolo por el CEIC de los centros implicados Evaluación por la AEM: calidad, seguridad y eficacia; inspección de GMP Evaluación por la Comisión Nacional de BioSeguridad (MMA) si es un OMG

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