The regulation of medicines quality, safety and efficacy are vital to protecting our health. To adopt and enforce sound medicines regulation, governments must put commercially-independent regulatory agencies in place.
It’s crucial that regulators implement robust marketing authorisation requirements for newly developed medicines before they enter the market. But of course, it doesn’t end there. Regulators must also put strong pharmacovigilance frameworks in place to monitor and assess the effects of medicines on patients once they enter the market (pharmacovigilance). If the harms of a medicine outweigh the benefits, regulators must then take appropriate action.
Transparency of all clinical data on medicines—particularly data from clinical trials and adverse drug reaction reports—is crucial. It enables healthcare professionals, consumers and patients to make informed decisions about treatment.
Health Action International advocates for sound drug quality, safety and efficacy regulation that puts public health first. We urge governments and regulatory agencies to adopt policies that contribute to better reporting of, and public access to, clinical data. We also insist the European Medicines Agency (and other regulatory bodies) remain free of pharmaceutical industry influence and include the voice of patients and consumers in pharmacovigilance regulation.