NRA's role in the regulation of drug safety

National regulatory authorities (NRAs)National regulatory authority (NRA)The regulatory body that approves procedures to ensure that medicines, including vaccines, are of adequate safety and potency. The vaccine manufacturer is responsible for demonstrating that the vaccine batch produced meets the requirements, based on the test specifications given by the NRA. The NRA is also responsible both for the official vaccine lot release process, based on the data and information provided by the manufacturer and, eventually, for confirmatory testing. are responsible for ensuring that every pharmaceutical product – including vaccines – used within the country is:

  • Of good quality,
  • Of known potency,
  • Safe for the purpose or purposes for which it is proposed.

Whereas the first two criteria must be met before any consideration can be given to approval for medical use, the issue of safety is more challenging.

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 in the pre-licensure development of a drug. It is therefore generally accepted that part of the process of evaluating drug or vaccine safety must happen post-licensure (post-marketing).

Pharmacovigilance 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/in collaboration with NRAs. Pharmacovigilance centres have a significant role in post-licensure surveillance of ADRs. They may conduct:

  • Post-licensure surveillance of ADRs,
  • Data collection on AEFIs using standardized methodologies,
  • Data analysis,
  • Regular communications with NRA to update safety profiles.