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The key question is: What are the unsolved problems in RPE cell transplantation? Even if RPE cell transplantation in animal models has been successful, RPE transplantation in humans has failed due to problems associated with the supply of sufficient numbers of differentiated, functional cells. Should primary or cultured cells be used for transplantation? Culturing the cells prior to transplantation is inevitable to obtain sufficient numbers of cells. However, a common known problem in human cell culture is the loss of differentiation. How does the differentiation status of the cells influence transplantation success? Can typical cell functions be maintained? The influence of culture conditions on physiological characteristics, phagocytosis, melanogenesis, vitamin A-metabolism, etc., needs to be investigated. Are the transplanted cells capable of adhering and interacting in the host tissue? A major problem of cell transplantation is the adherence of the cells to the basal substrate, which is altered during retinal degeneration. Strategies to transplant whole sheets or cell suspensions underneath the retina were evaluated. The problems of secondary cell death and degeneration of neighbouring cells are still unsolved. Furthermore, little is known about immunological responses and ageing processes after cell transplantation. Urgent concerns of future studies are therefore maintenance of specific cell functions and differentiation after isolation, during cell culture and after transplantation. To answer all these questions, clinicians and scientists have to combine their efforts for the benefit of the patients. 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CVMP proposal for a List of Substances Essential for the Treatment of Equidae Background The recently amended legislation relating to veterinary medicinal products - Directive 2001 82 EC, as amended by Directive 2004 28 EC - includes specific provisions regarding the treatment of animals of the equine family: Article 10 2 ; provides for the derogation to the application of the general provisions of the so called cascade for food-producing animals under Article 11 of the abovementioned Directive for the treatment for horses provided that the animal concerned has been declared as not being intended for slaughter for human consumption, in accordance with Commission Decisions 93 623 EEC and 2000 68 EC "horse passport" ; . In addition, the provisions in Article 10 3 ; , which are by way of derogation from the provisions of Article 11 of Directive 2001 82 EC, allow the treatment of equidae that are intended for slaughter for human consumption with substances that are essential for their treatment, and a list of such substances shall be drawn up by the Commission for adoption under the comitology procedure. The withdrawal periods to be applied for the treatment with any of the substances from the list shall not be less than six months according to the control mechanisms laid down in Commission Decisions 93 623 EEC and 2000 68 EC. The general provisions for the use of the cascade, i.e. exceptional use under the direct personal responsibility of the responsible veterinarian, do apply. The provisions under Article 10 3 ; are to be understood that they exempt substances allowed to be used under the cascade provisions for food-producing animals under Article 11 of Directive 2001 82 EC, as amended, i.e. substances that are contained in veterinary medicinal products for other food-producing species and are included in Annex I, II or III or Council Regulation EEC ; No 2377 90, and substances included in Annex IV of Regulation 2377 90. The European Commission requested the CVMP to start the preparation of a draft list to be submitted to the Commission. Selection of substances essential for the treatment of equidae As a consequence of the above candidates for the list of essential substances will fall only under the following categories: active substances that are authorised for human use or for use in companion or exotic animals, but are not included in Annex I, II or III of Regulation 2377 90; active substances authorised outside the EU. The term "essential for the treatment of equidae" is understood as no alternative treatment would exist for a therapeutic indication, but allowing also for a therapeutic choice in specific cases, e.g where specific conditions require different medication and or mode of action. Where an alternative for the treatment of a specific condition exists in a veterinary medicinal product that is included in Annex I, II or III of Regulation 2377 90 and is authorised for horses or for other food producing species and could therefore be used under the cascade, a substance cannot be considered as essential even when generally more accepted by veterinarians. Substances for the treatment of chronic diseases that would not allow discontinuing the therapy and do therefore excempt the complience with the minimum withdrawal period of 6 months are not.

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