EU Updates Inspections and Drug-Shortage Systems for COVID-19
European Union (EU) authorities have set alternative measures for inspections of drug-manufacturing facilities in the EU during the novel coronavirus (COVID-19) outbreak and have launched a new system for reporting shortages of COVID-19-related medicines.
Inspections during COVID-19 pandemic
The European Commission, the European Medicines Agency (EMA), and national competent authorities have put forth a series of mitigation measures to ensure continued availability of medicines with compliance to good manufacturing (GMP) and good distribution practice (GDP) by enabling remote assessments of compliance during the COVID-19 outbreak. Current national and international safety measures and travel restrictions affect or prevent on-site inspections.
Measures detailed in an update to a question-and-answer (Q&A) document, developed jointly by the European Commission, the EMA, and the Heads of Medicines Agencies, provide guidance on adaptations to the regulatory framework to address COVID-19 challenges. For instance, the validity of GMP certificates and time-limited manufacturing and import authorizations, as well as the validity of GDP certificates and time-limited wholesale authorizations, 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. Inspections, including distant assessments, may be launched and appropriate regulatory actions will be triggered in case of non-compliance.
In addition, the update provides information on adjustments that can be applied to the work of qualified persons (QPs), 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.
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 said the EMA in April 20, 2020 statement.
New system for reporting shortages of COVID-19-related medicines
In a separate development, the EMA, with the pharmaceutical industry and EU member states, has launched an enhanced fast-track monitoring system to help prevent and mitigate supply issues for medicines used for treating patients with COVID-19.
Under this system, each pharmaceutical company will appoint a single contact point (an industry single point of contact, or i-SPOC) who will report to the EMA and national competent authorities all current and anticipated shortages of medicines used in patients with COVID-19, both for centrally and nationally authorized medicines.
The system has been set up by the EU Executive Steering Group on Shortages of Medicines Caused by Major Events, which provides strategic leadership coordinated action on shortages within the EU in the context of the COVID-19 pandemic. The EMA will coordinate information received from pharmaceutical companies on supply shortages and share it with the EU Executive Steering Group, which will decide on EU-level coordinated actions to address these supply shortages in the best way.
The mechanism is similar to the network of single points of contact in national competent authorities (EU SPOC network) that the EMA, the national competent authorities in EU member states and the European Commission have already been using to share information on shortages and availability issues of authorized medicines since April 2019.
Due to the large number of companies involved, the i-SPOC system is being launched in two phases.
In the first phase, which started on April 17, 2020, the scope of reporting by the pharmaceutical industry will focus on current or anticipated shortages of a subset of medicines, authorized and marketed in the EU/European Economic Area (which consists of EU member states and three countries of the European Free Trade Association, Iceland, Liechtenstein and Norway, excluding Switzerland) used in the treatment of COVID-19 patients in hospital intensive-care units, such as anesthetics, antibiotics, resuscitation drugs, and muscle relaxants, which are currently in greatest demand. The second phase will focus on reporting of shortages for a broader range of medicines used in the treatment of COVID-19 patients.
The EMA reports that several hundred pharmaceutical companies have been contacted directly by the EMA and provided with a template via which they can report current or anticipated shortages to the EMA and propose mitigation measures. Pharmaceutical companies also must continue to report shortages to the national competent authorities concerned in line with their applicable national legislation.