Update to guidance on regulatory expectations in the context of COVID-19 pandemic
The European Commission, EMA and the national competent authorities have agreed a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing facilities or other sites relevant for medicinal products in the European Union.
Current national and international safety measures and travel restrictions affect or prevent the conduct of on-site inspections related to good manufacturing (GMP) and distribution practice (GDP). The mitigation measures have been taken to ensure the continued availability of medicines while making sure that good practice standards are being adhered to. This is achieved through proportionate approaches to verification of standards by enabling remote assessments of compliance.
Measures detailed in an update to the question-and-answer (Q&A) document, developed jointly by the European Commission, EMA and the Heads of Medicines Agencies (HMA), provide guidance to stakeholders on adaptations to the regulatory framework to address COVID-19 challenges. For instance, the validity of GMP certificates and time-limited manufacturing and import authorisations, as well as the validity of GDP certificates and time-limited wholesale authorisations will be extended until the end of 2021. If needed, inspections will be carried out remotely to support such extensions, with on-site inspections carried out as soon as feasible.
In addition, the update provides information on adjustments that can be applied to the work of qualified persons (QP), who are responsible for certifying that each batch of a medicinal product is suitable for release for sale or for use in a clinical trial.
These measures do not waive the obligations of manufacturers and importers to comply with GMDP standards. Supervisory authorities in the EU will remain vigilant to ensure the quality of medicines that are made available to patients in the EU. Inspections, including distant assessments, may be launched and appropriate regulatory actions will be triggered in case of non-compliance.
The update to the Q&A document applies to human medicinal products. A Q&A document on regulatory expectations for veterinary medicines is under preparation and will be published soon.