EMA communication: Regulatory Science to 2025 – strategy for a six-month public consultation

10 de enero de 2019 / por SEGCIB / European Medicines Agency

EMA has published its draft ‘Regulatory Science to 2025’ strategy for a six-month public consultation. This is a proposed plan for advancing the Agency’s engagement with regulatory science over the next five to ten years, covering both human and veterinary medicines. The strategy will help shape the vision for the next EU Medicines Agencies Network […]

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EMA Communication: Draft veterinary consultations

10 de enero de 2019 / por SEGCIB / European Medicines Agency

The European Medicines Agency has published the following reflection papers for consultation: Draft guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances – Deadline 31 August 2019 Draft guideline on requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats – […]

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EMA Consultation: Discussion paper: Use of patient disease registries for regulatory purposes – methodological and operational considerations

27 de noviembre de 2018 / por SEGCIB / European Medicines Agency

The European Medicines Agency has released for public consultation a discussion paper on the use of patient disease registries for regulatory purposes – methodological and operational considerations. This discussion paper has been prepared by the Cross-Committee Task Force on Registries established by the EMA Patient Registries Initiative. The main objective of this initiative is to […]

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EMA Consultation: Draft guideline on the quality of water for pharmaceutical use

27 de noviembre de 2018 / por SEGCIB / European Medicines Agency

The European Medicines Agency has released for public consultation a draft guideline on the quality of water for pharmaceutical use. Water is one of the major commodities used by the pharmaceutical industry. It may be present as an excipient or used for reconstitution of products, during synthesis, during production of the finished product or as […]

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