Regulation of drug safety

NRAs are responsible for ensuring that every pharmaceutical, including vaccines, used within the country is:

  1. Of sufficient quality,
  2. Effective,
  3. Safe for the purpose or purposes for which it is proposed. 

There is a possibility that rare, yet severe, adverse events (such as those occurring with a frequency of one in several thousand) may not be detected during drug development before licensing, because the number of recipients in the trials is relatively small. It is therefore generally accepted that part of the process of evaluating drug safety must happen after licensing and marketing. The acceptability of a vaccine shall be based on its benefit-risk ratio.

PharmacovigilancePharmacovigilanceThe science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. is often conducted by national pharmacovigilance centresNational pharmacovigilance centreA governmentally recognized centre (or integrated system) within a country with the clinical and scientific expertise to collect, collate, analyse, and give advice on all information related to drug safety. on behalf of NRAs. These centres, in collaboration with NRAs, have a significant role in the surveillance of adverse drug reactions after licensing, including for vaccines, and have to be staffed with persons with experience in vaccinology or training in vaccine vigilance.