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OIE Procedure for Validation and Certification of Diagnostic Tests

OIE Procedure for Validation and Certification of Diagnostic Tests.

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OIE Procedure for Validation and Certification of Diagnostic Tests

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  1. OIE Procedure for Validation and Certification of Diagnostic Tests • If we agree on the interest of a Certification handled by the OIE organisation, we, Diagnostic reagents producers, would prefer an harmonisation and a sole and unique European (International) certification. To do so, it seems important that all authorities of the different European countries accept and validate a commune validation procedure (Oie should sign contract with local authorities). • It is also very important that standardized control technique and reference sera are available for every diseases and every partners. It should warranty the quality of the products and the system. • The cost of Certification is very high, and as a consequence, it will limit the number of potential tests validated as well as the number of disease. • We do not understand why we should pay royalties/fees on the global revenue of the kit when OIE certification is not needed in most of countries.

  2. European Technology Platform for Global Animal Health Vision 2015 • To facilitate and accelerate the development and distribution of the most effective tools for controlling animal diseases of major importance to Europe and the rest of the world, thereby improving human and animal health, food safety and quality, animal welfare, and marcket acces, contributing to achieving the Millenium Development Goals. • The strategic objectives of the Technology Platform in this aim should be to: • • Sustain and strengthen the research environment and infrastructure needed to support visionary research into animal health and in particular the epidemic animal diseases and zoonoses. • • Ensure that Europe has a multi disciplinary strategic research capacity with the core expertise and facilities to anticipate and respond rapidly to new and emerging animal deseases, including zoonoses. • • Maitain a highly competitive industry working in partnership with the research community, production stakeholders, the public sector and regulators. • • Facilitate the efficient and rapid transfert of discoveries into practical applications such as tests and vaccines for diagnosing  and controlling animal deseases. • • Ensure a supportive and harmonised regulatory environment that the balances risk against need, not only for the autorisation of vaccinses and tests but also in terms of sanitary standards required for international trade. • • Develop global alliances with international organistions and non-European countries, including developing and developed countries, to enhance research, development and new product delivery. • • Improve education, training and understanding throughout the whole supply chain from initial research through to the delivery of new products. • • Mobilise the public and private sectors in Europe to commit funds to effective R&D activities through public-private partnerships.

  3. Simplification of the registration procedure in the European Union • ACTUAL SITUATION : • Differences at several levels: •         • Methods (AFNOR norms, EC norms, OIE Manual) •         • Registration of kits (NRL : AFSSA, FLI, CERVA, …. ) •   Different procedures:- Product registration exists or does not exist depending on the country - Batch to batch release exists or does not exist depending on the country - Differences between notifiable and non notifiable diseases in some countries (i.e. France, Belgium, …) • Use of national standard sera, which do not always correspond to the international standard sera (same antibody concentration and / or same behaviour when used in dilution), if existing… • As a result the registration procedure is difficult to manage, time consuming and costly for the kit manufacturer. • WISHES : • •Harmonisation of methods (norms) • •Harmonisation of standard sera or better only one reference serum (or a panel of reference sera) by method • •A unique registration procedure for each product by a unique European / international reference laboratory. • •Or mutual recognition of the registration obtained in one of the European NRL by the other European countries (example BSE)

  4. Relation between Public Laboratories and Private Compagny • Can a public lab procedure diagnostic reagents?If yes, with what standard and what form? • Can a public lab market his reagents products?If yes, with what statut? • Can a reagents producer public lab, objectiveley make evaluation, comparison, give agreement to kits produced by a competitor company? • Can a public lab guarantee its results by using its own produced product?Example of possible conflict: UK (VLA), Netherlands (ID-DLO), Italy (Instituto prophylactico), Spain.

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