The European Pharmacopoeia Commission and its 61 expert groups and working groups quickly adapted to the circumstances to continue operations, relying in particular upon virtual and, more recently, hybrid meetings. All meeting dates and publication deadlines have been respected since the pandemic was declared, thanks to the efforts and adjustments of all the stakeholders involved.

The European Pharmacopoeia Online and its public consultation platform Pharmeuropa, as well as all other databases and documentary resources, are functioning normally. The same is true for the European Pharmacopoeia Archives, available to all users with an up-to-date subscription.

The EDQM continues to ensure the supply of its reference standards to help maintain the availability of quality medicines in Europe and beyond. Although the supply chain situation has improved since the start of the pandemic, shipping is still difficult in some countries. The EDQM systematically strives to find the best shipment options, but delays may still occur for some destinations.

EDQM activities related to the Certification procedure are progressively coming back to normal.

Evaluation sessions have recommenced at the EDQM premises with assessors from national competent authorities, thanks in part to the lifting of travel restrictions, and the delays encountered during the pandemic have being reduced. Actual timelines are reported regularly in the CEP monthly reports published on the EDQM website.

The EDQM resumed its on-site inspections starting in August 2022. Where travel restrictions still apply, the “Real-Time Remote Inspections” procedure (or RTEMIS) is implemented. More information on this procedure is available on the EDQM web site: EDQM remote inspections: from pilot phase to a permanent element of EDQM’s inspection scheme!

The EDQM collaborates closely with the OMCLs involved in the testing of human and veterinary medicines to help ensure continuity of important activities, including the Official Control Authority Batch Release (OCABR) of vaccines and human blood- and plasma-derived medicinal products. Thanks to careful contingency planning at the OMCLs, the release of non-COVID-19-related products continued at normal levels even at the height of the pandemic.

To organise the transfer of the batch release tests for COVID-19 vaccine candidates to OMCLs earlier than in the usual process, the EU OCABR Advisory Group prepared a recommendation document on method transfer for OMCLs and manufacturers. The OCABR network members also prepared a list of OMCLs with capabilities relevant to the release of COVID-19 candidate vaccines to help manufacturers identify potential partners for the OCABR of their candidate vaccines. It is updated regularly to adapt to the existing conditions. Manufacturers can request a copy of either document at [email protected].

OCABR guidelines for pandemic COVID-19 vaccines were prepared at an early stage in order to help anticipate the launch of the first vaccines and allow OMCLs and manufacturers to take the necessary steps to prepare for OCABR, thus preventing delays in availability while still ensuring their quality and safety.

Thanks to this activity and the action and co-operation of regulators and manufacturers, batches of all COVID-19 vaccines with conditional marketing authorisation (cMA) approval in the EU were released and ready to reach patients as soon as the cMA approval was granted.

The EDQM continues to work with all stakeholders to protect public health by ensuring the necessary quality, safety and security checks for COVID-19 candidate vaccines are maintained, and by promoting access to vaccines.

Access to the guidelines can be found on the web page: "OCABR activities related to COVID-19 vaccines".