In the pharmaceutical industry, the safety of drugs is of utmost importance. Once regulatory authorities approve a drug, it is crucial to monitor its safety and efficacy continuously. Regulatory agencies (RA) such as the European Medicines Agency (EMA) require pharmaceutical companies to submit Periodic Safety Update Reports (PSURs) regularly to ensure patient safety. The PSUR is a vital tool for monitoring the safety of medicinal products, as it provides a comprehensive assessment of the safety profile of a drug. This article will explain everything you need to know about PSURs.
What is a PSUR?
A PSUR is a report that provides a detailed evaluation of the safety and efficacy of a medicinal product. It is a requirement for all medicinal products authorized in the European Union (EU), and it must be submitted to the EMA at predefined intervals. The primary purpose of a PSUR is to evaluate the safety and efficacy of a drug and identify any new safety concerns that may have arisen since the drug’s authorization.
Why are PSURs important?
The purpose of a PSUR is to evaluate a medicinal product’s safety and identify any new or emerging safety concerns. The report aims to provide a complete overview of the product’s benefit-risk profile based on the latest available data. This includes data from clinical trials, post-marketing surveillance, and other relevant sources. PSURs are essential because they help regulatory authorities make informed decisions about the safety of a product. In case of identifying new safety problems, the regulatory authority may take various measures to change the drug’s marketing authorization to ensure patients’ safety. For example, the RA may update the product’s labeling, change the dosage or timing of administration, or even change the indications for use. In cases where the safety problem is severe or irreversible, the RA may even restrict the use of the drug or revoke its marketing authorization.
How are PSURs prepared?
The responsibility for preparing PSURs lies with the drug’s Marketing Authorization Holder (MAH). The MAH is the company that holds the license to market the drug. They must have a pharmacovigilance system in place to monitor their products’ safety and report any adverse events to regulatory authorities. The company is responsible for collecting and analyzing all the relevant safety data, including clinical trials and post-marketing surveillance data. The MAH’s pharmacovigilance department or a contract research organization (CRO) that specializes in pharmacovigilance usually prepares the PSUR.
What information is included in a PSUR?
The PSUR must include a summary of all adverse reactions and other safety concerns reported since the last PSUR. The report must also include a comprehensive evaluation of the product’s benefit-risk profile, taking into account the latest available data. A PSUR typically contains the following information:
- A review of the drug’s safety profile over the reporting period, including any new safety concerns or changes to the drug’s labeling.
- An analysis of adverse drug reactions (ADRs) reported during the reporting period, including the frequency and severity of each ADR.
- An evaluation of the drug’s efficacy and effectiveness over the reporting period.
- An assessment of the drug’s benefit-risk profile.
- A summary of additional studies or clinical trials conducted during the reporting period.
- A list of new or updated risk minimization activities implemented during the reporting period.
- Any changes to the drug’s marketing authorization or regulatory status.
Literature data in PSUR
The literature section in a PSUR is crucial for identifying new safety concerns related to the drug. It provides a comprehensive overview of relevant scientific literature published during the reporting period. Regulatory agencies, such as the EMA, require a thorough review of relevant scientific literature in PSURs. It is important to note that current pharmacovigilance guidelines and regulations should prepare the literature section. So this means that the MAH should have a robust process for identifying relevant scientific literature, evaluating its relevance to the drug’s safety and efficacy profile, and promptly reporting any new safety concerns to regulatory authorities.
How often are PSURs submitted?
Once the PSUR is complete, it is submitted to the RA for review. PSURs must adhere to predefined intervals, which depend on the type of drug and its development stage. For example, the MAHs for medicines subject to assessment at the EU level must submit the relevant PSURs according to the requirements set up in the EU reference dates (EURD) list. The RA may request additional information or clarification if necessary. Once the review is complete, the RA will provide feedback to the pharmaceutical company and may take regulatory action if needed.
Conclusion for the pharmaceutical industry
In conclusion, PSURs are a vital tool for monitoring the safety and efficacy of medicinal products. They provide an updated evaluation of the product’s benefit-risk profile and identify any new or emerging safety concerns. Pharmaceutical companies are responsible for preparing and submitting PSURs regularly to regulatory authorities, who use the information to make informed decisions about the product’s safety. Regulatory authorities evaluate PSURs to ensure that the benefits of a drug continue to outweigh the risks. They will also look for any new safety concerns or changes to the drug’s labeling that may be necessary. The scientific medical literature is essential for assessing the risk/benefit ratio and identifying new drug therapy risk factors. Therefore, MAHs must continuously monitor medical literature in specialized journals to identify safety issues. In turn, the DrugCard platform will always help you stay informed about the safety of your drugs.