ICMRA high-level meeting on global health emergencies and regulatory approaches
On 1 and 2 December, International Coalition of Medicines Regulatory Authorities (ICMRA), a group of leading medicines regulatory authorities and experts from around the world, held a high-level meeting to discuss regulatory challenges, including those faced during the ongoing COVID-19 pandemic. Participants from the 24 members and 13 associated members and experts from the World Health Organization and the European Commission also discussed the path towards regulatory alignment on the global response to the Omicron variant.
“The pandemic has increased the urgency for us to converge on responses both to existing regulatory challenges and complex new ones,” said Emer Cooke, Chair of ICMRA and EMA’s Executive Director. “ICMRA has proven its value during the COVID-19 response, both as a platform for sharing information and best practices and as a venue for providing strategic leadership, active information sharing, pragmatic solutions and regulatory convergence.”
One of the goals of the meeting was to exchange information on regulatory approaches to the COVID-19 response, draw lessons learned and identify future priorities and opportunities to strengthen regulatory preparedness for future public health emergencies. Meeting participants also reflected on other important issues that are on the agenda of medicines regulators and public health bodies, including the fight against antimicrobial resistance, medicines for use in pregnancy and supply chain integrity.
The meeting was hosted by the Brazilian National Health Surveillance Agency (ANVISA) and co-chaired by Antonio Barra Torres, Director of ANVISA, and Emer Cooke, Chair of ICMRA and EMA’s Executive Director. A meeting report summarising the outcomes of the discussions will be published on the ICMRA website in due course.
ICMRA Statement on Need for Continued Focus on COVID-19 Therapeutics
07 December 2021
ICMRA presents this statement to highlight the significance of the continued need for development of additional therapeutics to treat and prevent COVID-19.
Since the World Health Organization’s declaration of the pandemic in March 2020, remarkable advances in health product development have made a significant impact against COVID-19. These advances include the development and marketing of several new testing devices, numerous disinfectants and sanitizers, different types of personal protective equipment, a variety of products to assist patients in hospitals and intensive care units (ICU), some new treatments, and a number of new vaccines. While several vaccines have been successfully brought to market and are currently being deployed globally, with several others under development, more efforts are needed to increase the availability of and access to effective treatments across the disease spectrum.
The International Coalition of Medicines Regulatory Authorities (ICMRA) has been convening since the beginning of the pandemic to share information, discuss scientific requirements for the development of drugs and vaccines for COVID-19, and develop aligned regulatory approaches. ICMRA has hosted workshops and issued several statements to assist regulators, industry, healthcare professionals, patients, and other stakeholders through the pandemic, including a statement on the need to conduct well-designed clinical trials for vaccines and treatments, to support regulatory decision-making.
Building on the actions taken to-date, ICMRA, through international collaboration, pledges to continue the efforts towards developing new therapeutics for COVID-19. This is especially important in order to have treatment options for people who are unable to be vaccinated or who have lower immune response to vaccines (e.g., people who are immunocompromised), and to address issues such as break-through infections, the emergence of SARS-CoV-2 variants with some level of vaccine resistance, and waning immunity. For these reasons, there is an ongoing need for safe, effective and accessible treatments to complement vaccination.
Some advancements have been made with small molecules, including antivirals and glucocorticoids, to treat severe disease and monoclonal antibodies for prophylaxis or to treat mild-to-moderate COVID-19 in non-hospitalized patients. Many of these treatments have become available in several countries. While these treatments are helpful, all may require parenteral (intravenous or subcutaneous) administration and/or specialized healthcare settings to monitor for adverse events. This necessitates additional treatments with ease of administration and accessibility. Recent advancements in oral antivirals for mild-to-moderate infection are encouraging, and may help fulfill the unmet need for easily accessible options. Furthermore, the entire spectrum of COVID-19 illness could benefit from new treatments (including prevention, early mild-to-moderate disease in non-hospitalized patients, severe disease in hospitalized and ICU patients, and for patients with long-COVID symptoms).
ICMRA calls on researchers, industry, healthcare professionals, health research funding agencies, research institutions, and others to focus development efforts on therapeutics addressing the full spectrum of the COVID-19 disease in all populations and in particular, including underrepresented or underserved populations such as pediatric patients and pregnant individuals. SARS-COV-2 variants of concern should be prominently addressed in these efforts. ICMRA encourages that application for use in low and middle-income countries, also be a focus in the development of antivirals and other treatments that are safe, effective and easy to deploy.
As expressed in previous statements, ICMRA encourages collaboration to ensure the design of robust clinical trials that can deliver actionable results, with prioritisation of therapeutics with a high probability of success. Additionally, ICMRA will continue to support ongoing and sustained international collaboration on pharmacovigilance and post-approval systems to equip regulators with data and information that supports well-informed and timely action.