Preventive strategies for COVID-19 include a variety of non-pharmaceutical interventions (NPIs) such as social distancing and the use of personal protective equipment (PPE). Reliable case identification and contact tracing guide the distribution of supplies and implementation of NPIs. In this blog post, we discuss how regulatory agencies have addressed the ongoing need for NPI, PPE, testing and contact tracing.
Beyond vaccines, preventive strategies for COVID-19 infections include a variety of non-pharmaceutical interventions (NPIs) such as social distancing and the use of personal protective equipment (PPE). Reliable case identification and contact tracing guide the distribution of supplies and implementation of NPIs. In this second post of our series, Monia Tumminello, Manager, Cortellis Regulatory Intelligence™, and Jaime Polychrones, Medical Writer, Cortellis Regulatory Intelligence, discuss how the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have provided guidance to address the ongoing need for NPI, PPE, testing and contact tracing.
Digitizing regulatory processes
As the world began to realize the impact and spread of COVID-19, public health initiatives quickly adopted social distancing and shutdowns as preventive measures.
A rapid shift to digital and remote operations for regulatory agencies was needed. Flexibility was key.
- Meetings were cancelled, rescheduled or moved to virtual platforms.
- Domestic inspections were scaled back.
- Audits were postponed.
- Submission dates were delayed.
- Membership applications were suspended.
- Flexibility was introduced into adverse event reporting.
- Remote Good Clinical Practice (GCP) inspections were introduced.
- Fees related with in-person meetings or inspections were reconsidered.
The European Commission (EC) has also issued and updated a business continuity plan to “ensure that core public and animal health regulatory activities during the COVID-19 pandemic continue to be carried out in terms of the authorization, maintenance and supervision of medicines.”
To ensure safe healthcare provision, the FDA issued new policies allowing manufacturers of certain FDA-cleared non-invasive, vital sign-measuring devices to expand their use so that healthcare providers can use them to monitor patients remotely, including fetal and maternal monitoring. This expanded the availability of digital health therapeutic devices for psychiatric disorders; and allowed the remote reviewing and reporting of scanned digital images of pathology slides.
Medical and personal protective equipment
As the number of cases increased, PPE quickly became in short supply. The EC quickly published revised, harmonized standards and guidelines to help ramp up production of masks, hand cleaners and disinfectants and other PPE, including the use of 3D printing in the context of the COVID-19 outbreak. Some topics addressed were:
- assessing applicable legal and technical requirements before importing new products to the EU;
- launching new or reconverting existing facilities to produce PPE like masks, gloves and surgical gowns; and
- providing examples of technical standards that manufacturers may use to place compliant 3D-manufactured products on the E.U. market.
The EC also recommended that all economic operators, notified bodies and market surveillance authorities throughout the supply chain support efforts to ensure the supply of PPE and medical devices throughout the E.U. market match the continuously increasing demand. This included reducing the list of products requiring export authorization and temporarily waiving customs duties and VAT across Member States.
The European Committee for Standardization (CEN) and European Committee for Electrotechnical Standardization (CENELEC) agreed to make freely available a number of European standards for certain medical devices and PPE so that both EU and third-country companies willing to manufacture these items could quickly start production and place products on the international market more easily while ensuring a high degree of safety.
The FDA relaxed import requirements, expanded manufacturing capabilities for PPE supplies, issued an MOU for point-of-care 3D printing, and expanded PPR availability.
In the U.S., the FDA also relaxed import requirements, expanded the ability to manufacture supplies such as hand sanitizer to companies not previously approved to do so, issued a memorandum of understanding regarding 3D printing to manufacture products at the point of care, granted an Emergency Use Authorization (EUA) for the emergency use in healthcare settings of certain ventilators and anesthesia gas machines modified for use as ventilators, and released guidance regarding the enforcement policy for gowns, gloves and other apparel to expand the availability of PPE.
Consistent, reliable testing
Recognizing the importance of testing for detecting cases to prioritize treatment and monitoring the impact of the pandemic, regulatory agencies expedited the process for developing and releasing validated diagnostic tests. The FDA held testing workshops for stakeholders developing or who had developed diagnostic tests for COVID-19 on a weekly basis starting in March and continuing throughout the year. The materials from each workshop are available on the FDA website.
The EC adopted guidelines on COVID-19 testing in April, to set standards for the quality of test kits, set up a network of laboratories and monitor for counterfeit tests. Similarly, the FDA issued its own guidelines in May.
An E.U. survey conducted in early 2020 identified the lack of positive control materials as one of the top three challenges faced by laboratories for the reliable implementation of coronavirus tests. Therefore, in April, the Joint Research Centre (JRC) of the EC designed and released a new control material that laboratories can use to check the correct functioning of their coronavirus tests and to avoid false negatives. The FDA has also released reference panels for test validation. Both agencies have also committed to transparent reporting of test performance.
Rapid review and issuance of EUAs of diagnostic tests by the FDA began in February, with the Centers for Disease Control (CDC) diagnostic panel, and have continued throughout the year:
- EUAs issued for the first commercially distributed test and first point-of-care test in March,
- patient-collected samples at home in April,
- first antigen test in May,
- first next-generation sequence test in June,
- first point-of-care serology antibody test in September and
- first at-home self-test in November.
Along the way, additional tests in each of the categories were approved and revoked upon review of accuracy. With the impending seasonal flu season, combination diagnostic and differential tests were also rapidly developed, reviewed and granted EUAs to be able to differentiate the flu from COVID-19.
The EC has encouraged a common testing approach in Europe, publishing recommendations in September. By accessing the Emergency Support Instrument, the Commission mobilized €100 to directly purchase and deliver rapid antigen tests to Member States and signed an agreement with the International Federation of the Red Cross (IFRC) in November to contribute €35.5 million to scale up COVID-19 testing capacity in the E.U.
The European Commission signed an agreement with the International Federation of the Red Cross (IFRC) to contribute €35.5 million to scale up COVID-19 testing capacity in the European Union.
Protection of personal data in the fight against COVID-19
Contact tracing and understanding the spread of disease have been major aims of governments worldwide. Mobile location data can be a valuable resource for this purpose, and mobile apps for contact tracing and/or that allow submission of COVID-19-related data have proliferated. In fact, the EC has coordinated a multinational effort to ensure interoperability via a gateway that went live in October to link national apps, with Germany’s Corona-Warn-App, Ireland’s COVID tracker and Italy’s immuni among the first. With these developments, personal data protection has become a concern.
The EC released a gateway for national contact tracking apps throughout Europe to share data. Germany’s Corona-Warn-App, Ireland’s COVID tracker and Italy’s immuni were among the first to be linked.
The European Data Protection Board (EDPB) released a statement to answer whether “Member State governments can use personal data related to individuals’ mobile phones in their efforts to monitor, contain or mitigate the spread of COVID-19.” Personal data protection rules do not apply to data that have been appropriately anonymized; otherwise, the ePrivacy Directive enables Member States to introduce legislative measures to safeguard public security when anonymized data are not available. The GDPR (General Data Protection Regulation) is a broad piece of legislation and provides for rules that also apply to the processing of personal data in a context such as the one relating to COVID-19, in accordance with national law and within the conditions set therein.
Monitoring the pandemic
A key challenge with any widespread infection is keeping track of and minimizing the spread of infection, especially in our connected world. Access to essential protective equipment protects healthcare workers as well as the broader society. Minimizing exposure while ensuring ongoing care for non-COVID-19 conditions requires careful planning. In the next and final blog post of this series, we’ll discuss how these considerations have carried over into clinical trials and drug manufacturing.
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To read the rest of the blog series, visit clarivate.com/cortellis/tag/covid-regulatory-response/.
