EMA updates on regulatory expectations amid COVID-19

Regulatory NewsRegulatory News | 20 April 2020 |  By 

The European Medicines Agency (EMA) on Monday updated its recent question and answer guideline on regulatory expectations for medicinal products amid the coronavirus disease (COVID-19) pandemic.
The guideline, developed in collaboration with the European Commission and Heads of Medicines Agencies, includes four new questions and answers concerning good manufacturing practice (GMP) and good distribution practice (GDP) certificates, qualified persons (QP) and adverse event reporting. (RELATED: EMA Q&A explains regulatory expectations for drugs during the pandemic, Regulatory Focus 10 April 2020).
GMP and GDP certificates
To ensure the availability of medicines in the EU during the pandemic in light of safety measures and travel restrictions that prevent on-site inspections, EMA says the validity GMP and GDP certificates, as well as time-limited manufacturing, import and wholesale authorizations should be extended through 2021.
For sites within the European Economic Area (EEA), EMA says the extension for GMP certificates should be granted “without the need for further action form the holder of the certificate,” but does not apply to changes in the scope of the certificate or registration, such as new premises or new medicinal products.
For sites outside the EEA, EMA says the certificates should be extended, “unless the issuing/supervisory authority takes any action that affects the validity of the certificate.”
The guideline also offers the possibility of distant assessments for new sites and facilities within and outside the EEA that have not been inspected or where an inspection is required.
“If needed, inspections will be carried out remotely to support such extensions, with on-site inspections carried out as soon as feasible,” EMA says. The guideline notes that on-site inspections “will resume once COVID-19 restrictions are lifted,” on a risk-based schedule.
EMA stresses that the measures laid out in the guideline “do not waive the obligations of manufacturers and importers to comply with [good manufacturing practice and good distribution practice].”
Qualified persons
While EU GMP rules allow for remote batch certification, EMA notes that some member states have introduced additional requirements “which may preclude remote certification.” In light of current travel restrictions, EMA says that, “Remote certification should be acceptable in all EEA member states,” during the pandemic.
The guideline also says that QPs can conduct remote audits of active substance manufacturers. “Where on-site audits are not possible, the QP can rely on paper-based audits and also take into consideration the results of inspections from EEA authorities,” EMA writes, noting that the audits “should provide confidence that the active substance is fit-for-purpose and will not negatively affect the safety and efficacy of the medicinal product.”
QPs are also given the go-ahead to rely on various documents to support the batch release of imported investigational products from third countries. “To make that assessment, where on-site inspections are not possible, the QP may rely on a variety of documents including, as appropriate: batch records,  including in-process test reports and release reports, the validation status of facilities, processes and methods, examination of finished packs, the results of any analyses or tests performed after importation (where relevant), stability reports, the source and verification of conditions of storage and shipment, audit reports concerning the quality system of the manufacturer, etc,” EMA writes.
Adverse event reporting
In a move similar to one made by the US Food and Drug Administration (FDA) last month, EMA is providing guidelines for marketing authorization holders (MAHs) to prioritize the submission of individual case safety reports (ICSRs) in situations where they are unable to continue standard reporting operations due to the pandemic. (RELATED: FDA revamps adverse event reporting guidance for COVID-19, Regulatory Focus 19 March 2020).
According to the guideline, MAHs should first prioritize the submission of serious ICSRs for products used to treat or prevent COVID-19, before submitting other serious ICSRs. Beyond serious ICSRs, EMA says MAHs should prioritize non-serious ICSRs for products used in relation to COVID-19 before submitting other non-serious ICSRs.
EMA says it is “essential that MAHs report all serious ICSRs within the 15 days set out in Directive 2001/83/EC,” and that MAHs who are forced to prioritize ICSRs should make a note in their pharmacovigilance master file regarding the practice.
EMA, Guideline


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy