EDQM: Availability of Reference Standards

The EU Pharmaceutical Legislation Reform: Impact on the API Industry

Recommendation

21 October 2025
Barcelona, Spain

The EU Pharmaceutical Legislation Reform: Impact on the API Industry
An ECA Course prior to the 28th APIC/CEFIC Global GMP & Regulatory API Conference

On the website of the EDQM (European Directorate for the Quality of Medicines & HealthCare), the list of available reference standards is updated at a regular basis. This list comprises more than 3000 substances, including chemical reference substances, herbal reference standards and biological reference preparations, as well as reference spectra for performing tests and assys according to Ph. Eur. methods.

In addition, the EDQM summarises in tabular form on its website which reference standards have been replaced by new batches and which substances have been removed from the list of reference substances (since January 2022) or will be deleted in future (from April or July 2022 onwards).

The website also provides information on changes related to the sales units of the standards, on updates of the transport and storage conditions of the substances as well as on special announcements regarding the prices of the substances.

Finally, it is described and additionally presented in a video how reference substances can be ordered.

The complete list of all available reference standards and the substances affected by the updates can be found on the EDQM website.