A Guide to Good Pharmacovigilance Practice

Importance

Pharmacovigilance and GVPs are incredibly important in protecting people from an adverse reactions from products designed to aid them with their ailments. The main goal of GVPs is to promote safe and effective medication. Most countries have their own agencies that lay out GVPs and ensure that all pharmaceutical companies comply with the practices.

So, aside from ensuring the safety of products, GVPs are also important in complying with relevant rules and regulations. When running a pharmaceutical company or working in this industry, it’s very important to understand GVPs for your country and the requirements for compliance to avoid trouble and also protect the public from any adverse reactions.

After medications have been licensed for public use, it’s important to monitor them during their entire life cycle and ensure that the products are safe and effective. This is why pharmacovigilance and GVPs play a major role in the industry, regardless of where you conduct your operations.

The European Medicines Agency and Good Pharmacovigilance Practice (GVP in Europe)

In Europe, Good Pharmacovigilance Practices were laid out by the European Medicine Agency (EMA). These guidelines were released in 2012 and are designed to facilitate and ensure pharmacovigilance for countries in the European Union. These practices have been divided up into 16 separate modules, each focusing on a particular area of pharmacovigilance.

One of the major aspects of the EMA’s GVP is requiring the establishment of a Pharmacovigilance Risk Assessment Committee, also called a PRAC. This committee is tasked with handling all the risk assessment and management concerns around an approved pharmaceutical product to ensure that all products on the market have maximized benefits and minimal risks.

The EMA is also responsible for implementation and compliance with GVP in EU member states.

The Food and Drug Administration and Good Pharmacovigilance Practice (GVP in the US)

In the United States, the agency in charge of Good Pharmacovigilance Practices and compliance with the practices is the Food and Drug Administration (FDA). The FDA’s GVP guidelines were established and released in 2005, but unlike the EMA’s GVPs, the FDA’s guidelines are not legally binding. This means that while companies are encouraged to follow these GVPs, they aren’t required to do so.

These guidelines cover all medical products such as vaccines, OTCs, and general medicines. The main objective of these guidelines is to protect users by ensuring that all medical products and devices on the market are safe and effective.

In the United States, medical products and devices have to pass requirements laid out by the FDA Code of Federal Regulations (CFR) Title 21, which is implemented on a federal level.

Health Canada’s GVP

Health Canada implemented their GVP action program in 2004 which was to ensure that all medical products in Canada, whether from Market Holders or importers, meet their requirements and regulations. These guidelines also ensure that companies have systems in place to track and report adverse reactions to the product.

How to Comply with Good Pharmacovigilance Practice

Good Pharmacovigilance Practices may look different depending on the country. There are various agencies in charge of GVP such as Health Canada, the US FDA, the EMA, and many other equivalent agencies in other countries. This is why it’s imperative for companies to research their country’s GVPs and what agencies are in charge of overseeing compliance to learn how they can comply with GVP.

Complying with GVP involves constantly reviewing and re-reviewing your safety monitoring program for both pre and post-market products. This usually includes conducting comprehensive audits of these safety monitoring programs and correcting any issues that the audit may have caught.
When companies obtain poor GVP ratings, corrective actions must be performed as quickly as possible.

SafetyCulture for GVP