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Archive for month: December, 2016


New ISO specification for better management of animal welfare worldwide

…Likewise, the food industry is taking more action to better implement animal welfare management. The new ISO technical specification ISO/TS 34700:2016, Animal welfare management – General requirements and guidance for organizations in the food supply chain, will help the food and feed industry to develop an animal welfare plan that is aligned with the principles of the World Organization of Animal Health (OIE) Terrestrial Animal Health Code (TAHC)* and ensure the welfare of farm animals across the supply chain…


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Transition plan from Article 57/XEVMPD data submission to SPOR

In the context of the implementation of the ISO IDMP standards, the European Medicines Agency (EMA) is establishing services to support the management of master data, i.e. substance, product, organisation and referential (collectively referred to as ‘SPOR’) data. The European Commission, the European Union (EU) Network Data Board and the EU ISO IDMP Task Force have endorsed a phased implementation of the ISO IDMP standards. The phased implementation plan envisages the prioritisation of the ‘Referentials’ and the ‘Organisation’ management services (RMS and OMS) in 2016 with the view of making them available in 2017. This document is a preliminary communication on the foreseen transition from the current Article 57 processes to the ‘to be’ SPOR processes. It is aimed at clarifying the change management plan for the provision of information related to the referential and organisation entities, currently managed via the eXtended EudraVigilance Product Report Message (XEVPRM) format, within the OMS and RMS requirements. This document also includes the process change for submissions of approved substance information to the Agency. The requirements will apply to the marketing authorisation holders (MAHs) and sponsors of clinical trials currently submitting data in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD). The processes and technology for the EMA and the relevant stakeholders to enable the registration and maintenance of the master data are currently being established, and will be communicated to all stakeholders once available.

Source: European Medicines Agency

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Simpler website navigation for regulatory information on human medicines

New navigation to help users find information more easily

The European Medicines Agency (EMA) has simplified the navigation structure of the regulatory information on human medicines on its website, to help users from pharmaceutical companies find the information they need more quickly and easily.

EMA took action based on detailed feedback from a diverse range of industry stakeholders who use the EMA website for different purposes, and reorganised the navigation accordingly.

The new menu reflects the three main stages of the medicinal product lifecycle, because most industry users said they prefer to look for information on medicines regulation in this way.

Source: European Medicines Agency

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Implementation of ISO IDMP standards

The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). Following a phased implementation process, pharmaceutical companies will be required to submit data on medicines to EMA in accordance with these formats and terminologies.

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