REGULATORY SUBMISSION
An adverse event is reported and filed when a healthy volunteer/patient has a negative reaction to a drug. It contains information about the drug, its dose, purported effect, the patient’s health before and after the adverse event, and the patient reactions to the drug before and after the adverse event are among other things. Adverse event reporting sources include the information on the adverse event gathered from many sources. The types of reports include spontaneous/voluntary reports, clinical trials and post-marketing studies, regulatory reports, license partner reports, and literature reports.
When a report is received, it is evaluated for the four factors listed below to determine whether it is a genuine case:
1. Identifiable patient
2. Identifiable reporter
3. The drug suspected of causing reaction/event
4. Adverse event or fatal outcome
Once these prerequisites are met, an ICSR is submitted for the occurrence of the adverse event. The amount of serious health effect on the affected patient is used to characterise the occurrence. Adverse event (AE), Severe adverse event (SAE), Severe adverse reaction (SAR), Suspected unexpected serious adverse reaction (SUSAR), and Life-Threatening are the different types of events (LT). The case will be reported to the regulatory authorities when the ICSR has examined it for seriousness, causality, and labelling. Every report can make a difference.
Pharma companies must report safety information to regulatory authorities within certain timeframes. Regulatory authorities receive the following types of reports:
Expedited Reporting: Individual safety reports received by drug companies that meet particular precise criteria, including requirements for the seriousness of a clinical event. Whether or not a report has been previously seen, must be submitted expeditiously to regulatory authorities around the world.
Timelines for reporting:
· Clinical Death/Life-Threatening Cases and SUSAR (Suspected Unexpected Serious Adverse Reaction) Cases must be reported to the NCA/HA within 7 calendar days
· Other serious cases and safety problems in clinical trials are reported within 15 calendar days.
· Serious post-marketing cases are notified to the NCA/HA within 15 calendar days.
· Non-serious cases are notified to the EU health authorities within 90 days (EMA). Non-EU countries are not required to participate.
Periodic Safety Reporting:
In accordance with government rules, periodic safety reports are submitted to regulatory agencies. The goal of these periodic safety reports is to compile and analyse all adverse event reports received over a specified period of time. Periodic reports give an overall safety re-evaluation at set time intervals and aid in the continuous assessment of whether product information or the risk management plan should be changed. Periodic reports for marketed products are timed and written according to local standards (every 6 months, every year, every 3 years, etc). Periodic Safety Update Reports (PSURS) or Periodic Benefit Risk Evaluation Reports (PBRER) is the terms used in most countries to refer to post-marketing periodic reports. These reports are known as Periodic Adverse Drug Experience Reports in the United States (PADERS).
Periodic Safety Reporting timelines:
· EU Periodic reports: Every 6 months until product marketed for 2 years in EU then annually for 2 years, then every 3 years
· US Periodic reports: For 3 years after approval, quarterly periodic report. After 3 years, annual reports
Regulatory authorities reviews the results of laboratory, animal, and human clinical testing done by companies for pre-marketed products before approving worldwide. They monitor the benefit/risk balance of marketed drugs, in accordance with each country’s local or regional laws and regulations.
