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What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?

The Centre for Drug Evaluation and Research oversees a number of post-marketing surveillance programmes for ensuring continuing drug safety and efficacy. These include programmes to identify serious adverse events not detected during pre-approval studies, including via mandatory reporting by manufacturers, which can lead to revised drug labelling or in rarer instances re-evaluation of a marketing authorisation decision. The Food and Drug Administration also conducts periodic unannounced inspections of facilities that are part of the drug production and manufacturing process, and runs other programmes to ensure drug safety.

Data protection

What data protection issues should be considered when conducting pharmacovigilance activities?

Pharmacovigilance involves monitoring and evaluation of information relating to adverse effects of drugs, biologics and medical devices in public use. Because pharmacovigilance involves commercial products, public safety and brand protection are of utmost concern.

The brand protection aspect takes two forms:

  • Regulatory requirements must be wholly satisfied when reporting adverse events in order to maintain licensure and avoid punitive governmental actions. Timeliness and accuracy are key. 
  • Control of information during the news cycle must be maintained to ensure that accurate information is disseminated. Steps must be taken to minimise the possibility of rumours and false stories.

While some adverse events can result in a product losing its approval and being pulled from the market, others may require only additional warnings on the label, thus still allowing the product to be sold. Reputational damage is mitigated most effectively by rapid and accurate response. 

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