MAH stands for Marketing Authorization Holder. In pharmacovigilance, the MAH is the company or organization responsible for the safety of a marketed drug. They are legally obligated to collect, analyze, and report adverse events (AEs) related to their products.
Here's what the MAH does in pharmacovigilance:
- Collects AE data: The MAH receives reports of AEs from various sources, including healthcare professionals, patients, and other stakeholders.
- Analyzes AE data: They analyze the collected data to identify potential safety signals, assess the risk-benefit profile of the drug, and determine if any safety measures need to be taken.
- Reports AEs to regulatory authorities: The MAH is responsible for reporting AEs to regulatory authorities, such as the FDA (in the US) or the EMA (in Europe).
- Implements safety measures: If necessary, the MAH implements safety measures to mitigate identified risks, such as updating the product label or withdrawing the drug from the market.
In short, the MAH plays a crucial role in ensuring the safe use of marketed drugs by monitoring their safety and taking appropriate action to protect patients.
