Conference Uppsala, 10-11 Nov 2009Jean-Marc Vidal (EMEA) 1 Conference on Sustainable Development and...

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Transcript of Conference Uppsala, 10-11 Nov 2009Jean-Marc Vidal (EMEA) 1 Conference on Sustainable Development and...

  • Slide 1
  • Conference Uppsala, 10-11 Nov 2009Jean-Marc Vidal (EMEA) 1 Conference on Sustainable Development and Pharmaceuticals Uppsala, 10-11 November 2009 EMEAs role in a sustainable development todays situation and the future Dr Jean-Marc Vidal European Medicines Agency (EMEA) Acknowledgement to Kornelia Grein and Jordi Torren
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  • Conference Uppsala, 10-11 Nov 2009Jean-Marc Vidal (EMEA) 2 Outline EMEA mission & Pharmaceutical legislation Guideline principles: Evaluation and Precautions Role of the EMEA and Environment Protection Summary & Conclusion
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  • Conference Uppsala, 10-11 Nov 2009Jean-Marc Vidal (EMEA) 3 To protect and promote public health Allow rapid access to safe and effective innovative medicines Facilitating innovation and stimulating research Mobilising scientific resources from throughout the EU to provide high-quality evaluation of medicinal products To advise on research and development programmes EMEA Mission Statement
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  • Conference Uppsala, 10-11 Nov 2009Jean-Marc Vidal (EMEA) 4 EU Pharmaceutical Legislation Directive 2001/83/EC, as amended: Art 8 (3) The application shall be accompanied by the following particulars and documents, submitted in accordance with Annex I: (ca) Evaluation of the potential environmental risks posed by the medicinal product. This impact shall be assessed and, on a case-by-case basis, specific arrangements to limit it shall be envisaged. (d) Description of the manufacturing method. (e) Therapeutic indications, contraindications and adverse reactions. (f) Posology, pharmaceutical form, method and route of administration and expected shelf life. (g) Reasons for any precautionary and safety measures to be taken for the storage of the medicinal product, its administration to patients and for the disposal of waste products, together with an indication of potential risks presented by the medicinal product for the environment.
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  • Conference Uppsala, 10-11 Nov 2009Jean-Marc Vidal (EMEA) 5 Additional Specific Legal Requirements Radio-pharmaceuticals Council Directives 96/29/Euratom and 97/43/Euratom. Genetically Modified Organisms (GMOs) Directive 2001/18/EC Chemical Legislation REACH Water Framework Directive (GMP)
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  • Conference Uppsala, 10-11 Nov 2009Jean-Marc Vidal (EMEA) The CHMP Guideline CHMP Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (CHMP/SWP/4447/00) Legislative basis: Article 8(3) of Directive 2001/83/EC, as amended An ERA is REQUIRED for all new MAAs for a medicinal product through a centralised, mutual recognition, decentralised or national procedure. and for post-marketing submissions (type II variations, line extension). Not renewals for human medicines.
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  • Conference Uppsala, 10-11 Nov 2009Jean-Marc Vidal (EMEA) 7 ERA Veterinary Medicines CVMP guidance from 1996 superseded by CVMP-VICH guidelines :CVMP guidance from 1996 superseded by CVMP-VICH guidelines : Phase I (VICH GL6) (July 2000) Phase II (VICH GL38) (October 2005) CVMP guideline in supporting VICH GLs 6 & 38 (EMEA/CVMP/ERA/418282/2005- Rev.1)CVMP guideline in supporting VICH GLs 6 & 38 (EMEA/CVMP/ERA/418282/2005- Rev.1) Finalised in 2008 + Q&A document
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  • Conference Uppsala, 10-11 Nov 2009Jean-Marc Vidal (EMEA) 8 Status of Guidelines vs Legal requirements To be considered as harmonised Community position If followed by relevant parties such as applicants, marketing authorisation holders, sponsors, manufacturers and regulators will facilitate assessment, approval and control of medicinal products in the EU. Nevertheless, alternative approaches may be taken, provided that these are appropriately justified EU Guidelines Ref.: EMEA/P/24143/2004
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  • Conference Uppsala, 10-11 Nov 2009Jean-Marc Vidal (EMEA) The CHMP Guideline CHMP Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (CHMP/SWP/4447/00)
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  • Conference Uppsala, 10-11 Nov 2009Jean-Marc Vidal (EMEA) 10 Entry Paths into the Environment
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  • Conference Uppsala, 10-11 Nov 2009Jean-Marc Vidal (EMEA) 11 Stage in regulatory evaluation Stage in risk assessment ObjectiveMethod Test /Data requirements Phase IPre-screening Estimation of exposure Action limit Consumption data logK OW Phase II Tier AScreening Initial prediction of risk Risk assessment Base set aquatic toxicology and fate Phase II Tier BExtended Substance and compartment- specific refinement and risk assessment Risk assessment Extended data set on emission, fate and effects Step-Wise Approach
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  • Conference Uppsala, 10-11 Nov 2009Jean-Marc Vidal (EMEA) 12 Phase I principles In phase I, the estimation should be based only on the drug substance, irrespective of its route of administration, pharmaceutical form, metabolism and excretion With reference to the OSPAR Convention, drug substances with a logK OW >4.5 should be screened, in a step-wise procedure, for persistence, bioaccumulation and toxicity according to the EU TGD Certain substances, such as highly lipophilic compounds and potential endocrine disruptors, may need to be addressed irrespective of the quantity released into the environment In Phase I the PEC calculation is restricted to the aquatic compartment
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  • Conference Uppsala, 10-11 Nov 2009Jean-Marc Vidal (EMEA) 13 Phase I calculation ParameterSymbolValueUnit Maximum daily doseDOSEaimg*inh -1 d -1 Market penetrationFpen0.01(default) Amount waste waterWASTEWinhab200 (default)L*inh -1 d -1 Dilution factorDILUTION10 (default) Predicted concentrationPEC SURFACE WATER (OUTPUT)mg*L -1 Calculation of the Predicted Environmental Concentration (PEC) PEC SURFACE WATER = DOSEai * Fpen WASTEWinhab * DILUTION
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  • Conference Uppsala, 10-11 Nov 2009Jean-Marc Vidal (EMEA) 14 Phase I calculation parameters The initial calculation of PEC SURFACE WATER assumes: A fraction of the overall market penetration (Fpen). The applicant may refine this fraction by providing reasonably justified market penetration data, e.g. based on published epidemiological data The predicted amount used per year is evenly distributed over the year and throughout the geographic area The sewage system is the main route of entry of the drug substance into the surface water There is no biodegradation or retention of the drug substance in the STP Metabolism in the patient is not taken into account
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  • Conference Uppsala, 10-11 Nov 2009Jean-Marc Vidal (EMEA) 15 Phase I threshold Action limits PEC SURFACEWATER