Pharmaceutical industries require their products to be able to promote drug safety during the lifecycle of such products. The Pharmacovigilance System Master File (PSMF) is one of the most important documents in favor of this endeavor in the European Union (EU) and other areas. So, what is a PSMF and why is this so essential to regulatory compliance?
What is the Pharmacovigilance System Master File (PSMF)?
A Pharmacovigilance System Master File (PSMF) is a complete and detailed document that explains the full pharmacovigilance (PV) system of a pharmaceutical company. The PV system encompasses all processes, structures, and resources involved in monitoring the safety of medicines once they are on the market.
To determine the effectiveness of the pharmacovigilance system of a company as per the requirements of the applicable laws and regulations, the PSMF is an apt instrument used by the regulatory bodies.
Why is the PSMF Important?
Pharmacovigilance is about the ongoing monitoring, detection, assessment, and prevention of adverse effects or any other drug-related problems. Regulatory agencies such as European Medicines Agency (EMA) mandate that companies have a PSMF so that drug safety monitoring is accomplished with transparency and accountability.
The PSMF allows regulators to:- Verify that a company has an effective pharmacovigilance system.
- Learn the process of collecting, maintaining and reporting safety data.
- Make sure that risks associated with medicinal products are detected and actively addressed.
Key Components of a PSMF
An effective PSMF will normally have the following sections:- Description of Pharmacovigilance System An elaborate description of the structure, positions, duties and practices of pharmacovigilance activities.
- Quality Management System Information on quality assurance processes related to pharmacovigilance.
- Pharmacovigilance Procedures and Processes Descriptions of how adverse event reports are handled, risk management activities, signal detection, and safety data analysis.
- Computerized Systems and Databases Information about the electronic systems of managing safety data, such as validation and access controls.
- Details of Qualified Persons Responsible for Pharmacovigilance (QPPV) Information on the designated individual responsible for ensuring PV compliance.
- List of Marketing Authorizations and Products Information about the medicinal products covered by the pharmacovigilance system.
Maintenance and Regulatory requirements
EU pharmacovigilance law states that a PSMF must be maintained, including Directive 2010/84/EU and Regulation (EU) No 1235/2010. The document must be kept up to date and readily accessible to regulatory inspectors at all times.
Pharmaceutical companies should revise and revise their PSMF at regular intervals, taking into consideration a significant change of the pharmacovigilance system or in the product portfolio.
How Masuu Global Supports Your PSMF Needs
At Masuu Global, we know that compliance and documentation of pharmacovigilance are complex. Our services include PSMF consulting and support services to assure your PSMF is developed, maintained and audited to align to EMA requirements and global best practice.
Pharmacovigilance System Master File (PSMF) is a strand hold document to the drug safety compliance in the EU. It gives regulators a clear scenario of your pharmacovigilance system and shows your interest in patient safety.
Contact Masuu Global today to enhance your pharmacovigilance procedures and make sure that your PSMF is audit-worthy. And united, we can confidently assist you to negotiate regulatory requirements.
