Pharmaceutical industry

On this page, you will find information on the Agency’s activities that are most relevant to pharmaceutical industry, including news, and events. You can contribute to the Agency’s work by responding to public consultations. Learn more about how the pharmaceutical industry is actively involved in the work of the Agency.

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  Survey on essential substances for the treatment of equine species

  EMA is inviting veterinarians, academics and relevant experts to assist the Agency in formulating a scientific opinion to update the European Union (EU) list of essential substances for the treatment of equine species. Please complete EMA’s survey by 30 June 2023 to contribute to this exercise.

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  Public consultation on single-arm clinical trials

  EMA is inviting medicine developers, patients and other stakeholders to comment on its reflection paper on single-arm clinical trials submitted as pivotal evidence in marketing authorisation applications. It concerns the key concepts, challenges, design and conduct of such trials to demonstrate efficacy. Provide your feedback by 30 September 2023.

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  EMA recommendations to reduce risks to humans and animals from exposure to N-methyl pyrrolidone in veterinary medicines

  EMA’s Committee for Veterinary Medicinal Products (CVMP) recommended measures addressing the inconsistencies in the product information of medicines containing the excipient N-methyl pyrrolidone (NMP), which are marketed in the European Union (EU). NMP can cause birth defects in children of women who handle NMP-containing medicines during pregnancy, and in the offspring of animals given these medicines.

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  New template for certificates of medicinal products

  A new EMA template is available for the certification of human and veterinary medicines. It applies to all related requests that EMA receives from 16 January 2023 onwards. The Agency updated this document to align with the new certification template introduced by the World Health Organization (WHO). This certification process serves to confirm a medicine’s marketing authorisation status and its compliance with good manufacturing practice standards.

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  New template and updated guidance for scientific advice

  A new briefing document template is available for scientific advice applicants. While it can already be used, it is only mandatory for requests with a deadline starting from 9 January 2023. In the transition period, applicants can still use the previous template. Updated guidance is also available including questions that should not be asked during the scientific advice process.

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  New online platform for GVP inspections

  As of 12 September 2022, marketing authorisation applicants and holders of human and veterinary medicines should use EMA’s IRIS Regulatory & Scientific Information Management Platform to communicate with EMA on GVP inspections requested by the Agency’s scientific committees. Guidance is available on how to register for IRIS and use it for GVP inspections and other procedures.

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  Guidance: clinical trials affected by the war in Ukraine

  Guidance is available for sponsors on how they can adjust the way they run clinical trials affected by the war in Ukraine, including actions they can take to help ensure the integrity of their studies and the interpretation of the study results while safeguarding the safety of trial participants as a first priority.

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