Q&A Notice on Regulatory Expectations and Flexibility
Most notably, the Q&A notice to stakeholders on regulatory expectations and flexibility for medicinal products for human use during the COVID-19 pandemic (the Q&A Notice, latest version available here), has extended the validity of good manufacturing practice (GMP) certificates that support the manufacture and importation of medicinal products in the European Economic Area (EEA) until the end of 2021, without the need for further action from the certificate holder. The validity of time-limited authorizations/registrations to manufacture/import are also extended until the end of 2021, likewise without the need for further action from the authorization/registration holder. Further, the Q&A Notice addresses the question of which adaptations to the work of the qualified person (QP) are possible, considering travelling and other restrictions arising from the COVID-19 pandemic.
The Q&A Notice also includes a section on pharmacovigilance: Marketing authorization holders (MAHs) who, for justified reasons relating to the pandemic, are unable to continue standard reporting operations should temporarily prioritize their reporting obligations as follows: (i) submission of serious individual case safety reports (ICSRs) associated with medicinal products used for the treatment or prevention of the pathogen causing the pandemic; (ii) submission of other serious ICSRs; (iii) submission of nonserious ICSRs associated with medicinal products used for the treatment or prevention of the pathogen causing the pandemic; and (iv) submission of other nonserious ICSRs. In this context, pharmaceutical companies should also refer to the European Medicines Agency’s (EMA) detailed guidance on ICSRs in the context of COVID-19 (available here).
The Q&A Notice will be updated on a regular basis to reflect developments of the pandemic.
Industry Single Point of Contact (i-SPOC) Monitoring System
The EMA together with EU Member States and pharmaceutical companies recently launched a fast-track monitoring system to help prevent and mitigate supply issues with crucial medicines used in intensive care for treating COVID-19 patients. Under this monitoring system, each pharmaceutical company must appoint a single contact point who will report to the EMA all ongoing or anticipated relevant shortages, irrespective of their authorization route. The i-SPOC monitoring system is similar to the single point of contact (SPOC) network, on which Sidley previously reported (here). The i-SPOC monitoring system is planned to be extended to a broader range of medicines in the future. For more information on the i-SPOC monitoring system, please see here.
EU Executive Steering Group on Shortages
European authorities recently established the so-called EU Executive Steering Group on Shortages of Medicines Caused by Major Events (the Steering Group), which aims to provide strategic leadership for urgent and coordinated action to prevent and mitigate supply disruptions within the EU during the pandemic.
During its fourth virtual meeting, which took place on April 29, 2020, the Steering Group was informed that the i-SPOC has received the first notifications of possible or anticipated shortages affecting medicines for use in COVID-19 patients (see here). The information received by the EMA concerns nationally authorized medicines, in particular antibiotics and anesthetics. The data collected so far indicates that shortages of some of these medicines are mainly driven by an unexpected surge in demand and by changes in prescribing behaviors.
During its fifth virtual meeting, which took place on May 6, the Steering Group and the heads of national competent authorities in the EU member states agreed to explore how national data models to forecast the demand for supply of medicines used in intensive care units (ICUs) can be shared within the EU medicines regulatory network to improve supply of medicines used in ICUs and address reported shortages in this field (see here).
Requests for European Solidarity
The European Commission recently published guidelines for EU Member States on the optimal and rational supply of medicines to avoid shortages during the COVID-19 outbreak. Based on the principle of solidarity, these guidelines request that EU Member States, inter alia, lift export bans on medicinal products within the internal market and avoid that misinformation leads to improper use and unnecessary stockpiling. The guidelines also recommend for EU Member States to take certain measures to ensure supply. Pharmaceutical companies with products on the EU market should expect national regulatory authorities to impose new requirements on them in an effort to ensure a more balanced distribution of stock.
New Pharmaceutical Strategy
Finally, the European Commission is developing a new pharmaceutical strategy for Europe that aims at ensuring the quality and safety of medicines (see announcement here). In light of COVID-19, we understand that a key focus of the new pharmaceutical strategy will be to address medicinal product shortages and in particular limit dependency on single manufacturers. The new pharmaceutical strategy is expected to address the establishment of means to produce essential medicines within the EU.
European regulators have recognized that during the current pandemic, supply chain disruptions can happen very quickly and unpredictably. The measures outlined in this alert aim to support pharmaceutical companies with products on the EU market. It remains key to communicate with customers, suppliers and regulators and ensure supply chain visibility and simplicity to the extent possible. Pharmaceutical companies with products on the EU market should monitor current COVID-19-related guidance and continue to follow existing guidance on how to manage medicinal product supply chains (reported on here and here).
For information on what the UK has been doing to address COVID-19 related concerns in support of care homes and hospices, please see here.