Regulatory COVID-19 Update: EMA and Clinical Trials; FDA and Generic Drugs

The European Medicines Agency has issued guidance on managing clinical trials impacted by the COVID-19 pandemic, and the FDA issued information for generic-drug manufacturers on conducting bioequivalence studies affected the by COVID-19 outbreak.

EMA provides updates to clinical-trial management

This week (April 28, 2020), the European Medicines Agency (EMA) updated guidance for clinical-trial sponsors on how they should adjust the management of clinical trials and participants during the COVID-19 pandemic. The guidance covers concrete changes and protocol deviations for dealing with extraordinary situations, such as the need for isolating participants, limited access to public spaces, and the reallocation of healthcare professionals.

The EMA’s guidance, issued on April 28, 2020, provides additional flexibility and clarification on several measures: (1) the distribution of medicines to trial participants to take into account social-distancing measures and possible limitations in trial site and hospital resources; (2) the remote verification of source data in the context of social-distancing measures; and (3) notification requirements for actions needed to be taken to protect trial participants against an immediate hazard or of other changes taken to support patient safety or data robustness.

The EMA also issued guidance on the actions that sponsors of clinical trials should take to help ensure the integrity of their studies and the interpretation of the study results while safeguarding the safety of trial participants. In line with this guidance, the EMA says it will be “flexible and pragmatic” during the assessment of affected clinical trial data submitted to the agency as part of marketing-authorization applications.

The issuance of guidance for clinical trials by EU authorities closely follows the FDA issuing final guidance on March 18, 2020 to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic. The FDA outlined that in the wake of COVID-19, certain challenges may arise in conducting clinical trials, for example, from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with SARS-CoV-2, the virus that causes COVID-19. The agency further updated this guidance on April 16, 2020.

Source: European Medicines Agency and US Food and Drug Administration

Bioequivalence studies in the wake of COVID-19

The FDA posted information and resources to assist manufacturers submitting generic-drug applications with bioequivalence studies that may be impacted during COVID-19. In its communication, the FDA said that it recognizes that the COVID-19 pandemic may impact the conduct of bioequivalence studies intended for submission in abbreviated new drug applications (ANDAs). It cited challenges that may arise from quarantines, site closures, travel limitations, interruptions to the supply chain for the proposed generic product or the reference listed drug product, or other considerations if site personnel or study subjects become infected with COVID-19. In addition, it noted that the process of interrupting and restarting bioequivalence studies for ANDAs may require protocol revisions and impact the collection of information needed to establish bioequivalence. The communication provides information and resources to generic-drug manufacturers encountering such issues.

Source: US Food and Drug Administration

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