Infectious disease risk safety prediction
The following points are explained about the method of predicting the risk of infectious diseases.
Post-marketing safety measures for drugs:
- This is a system to collect information on health hazards such as side effects and infectious diseases after drugs and medical devices are marketed, and to take appropriate measures.
- The basic pillars of ensuring safety after marketing are as follows.
- Adverse Reaction Reporting System: Suspected cases of adverse reactions are collected from pharmaceutical companies, doctors, pharmacists, and other medical professionals, and evaluated as necessary and necessary measures are implemented.
- Post-marketing surveillance: For new drugs, proper use is encouraged for six months after the launch of sales, and the system for collecting information on adverse reactions is strengthened.
- Reexamination: The efficacy and safety of new drugs are reconfirmed a certain period after the launch.
- Revision of package insert: Approved items are changed and cautions are issued.
Risk Management Plan (RMP):
- The RMP is a document that summarizes consistent risk management from drug development to post-marketing, and is evaluated according to progress. This information is shared with medical professionals to strengthen post-marketing safety measures. ²
Drug and Medical Device Safety Information Reporting System:
- This system allows medical professionals to report information about side effects and infectious diseases caused by the use of drugs and medical devices, and to take appropriate measures. The reported information is analyzed and evaluated, and used for post-marketing safety measures. ³
These measures ensure the safety of drugs after they are marketed.
