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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  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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  Guidance on the handling and shipping of investigational medicinal products

  New guidance is available for sponsors and manufacturers of investigational medicines for human use on the release and shipping of these medicines to clinical trial sites, in accordance with good clinical and manufacturing practice. The guideline is effective from 1 January 2023.

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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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  Change in contact details for queries on type II variations

  As of 18 March 2022, marketing authorisation holders should contact EMA's Service Desk for any regulatory or procedural queries on Type II variation applications, including clinical, non-clinical and risk management plan variations. EMA now has a dedicated pre-submission queries service to respond to questions about this type of variations.

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  EMA's Network Portfolio and Agile transformation

  EMA is phasing in an Agile way of working and governance model for its IT systems and services, both those in development and already in use by stakeholders, now known collectively as the Network Portfolio. The new approach includes hosting system demos, which are open to pharmaceutical industry participants. Find out more on our dedicated topic page.

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