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Guidance from Global Regulators Stresses Patient Safety, Risk Assessment
Regulators around the world have issued guidance and recommendations on how to navigate clinical trials during the COVID-19 pandemic. Here is a summary of actions some agencies in the southern hemisphere have taken:
- Mexico’s regulatory authority COFEPRIS recommended in a recent announcement that sponsors operating trials in the country develop a risk-management plan consisting of alternative safety measures to protect patients. Visits for currently enrolled participants may be rescheduled, COFEPRIS said, whereas recruitment of new participants should be postponed. Amendments to trials because of COVID-19 should be implemented immediately and submitted to the agency afterward.
- Similar to Mexico, Argentina also recommends sponsors develop a risk-management plan that will ensure safety of trial participants. Recruitment of healthy participants should be postponed unless a trial is directly studying COVID-19, said the National Administration of Medicines, Food and Medical Technology in that nation.
- Colombia has given its National Institute for Food and Drug Surveillance (INVIMA) permission to advance all COVID-19 trials approved by an ethics committee associated with a research center. A guideline for submitting trials to the INVIMA has been posted on the regulator’s website.
- In South Africa, the Health Products Regulatory Authority (SAHPRA) has issued guidance for clinical trials to help sponsors and CROs ensure the safety of trial participants during the pandemic. SAHPRA also recommends sponsors describe in their clinical study reports how COVID-19 impacted their trials to justify any protocol changes made or gaps in trial data.
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