Global Pharmacovigilance Regulations

Medicine is one of the most universal forms of healthcare. However, according to the American Society of Pharmacovigilance, adverse drug events alone are responsible for $13 billion in annual American healthcare costs. The U.S Department of Health and Human Services defines adverse drug events as undesirable consequences of taking certain medications, such as “medical errors, adverse drug reactions, allergic reactions, and overdoses”. It is internationally important that a medication is professionally assessed and monitored before it is deemed safe for consumers. This is where pharmacovigilance comes into play.

Pharmacovigilance (PV), or drug safety, is the study of a drug’s adverse effects. PV helps determine if a drug is safe for mass consumption before it is put on the market. In addition, PV ensures that if drugs with serious adverse drug reactions are pulled from the market. The field is an integral part in clinical research. In this article, we will explore the various agencies and regulatory bodies that supervise PV as well as clinical research. For those interested in becoming a pharmacovigilance expert, Pharmacovigilance Certification is available to guide you through the essentials of drug safety.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH): Created in 1990, the ICH connects global regulatory bodies and pharmaceutical companies to share technical innovations and discuss guidelines. The ICH GCP, or Good Clinical Practice, is one of the global governing clinical research guidelines for the EU, America, and Japan. Understanding and staying up to date with the ICH GCP is one of the most important qualifications someone could have before entering the clinical research industry. If you have any interest in clinical research and PV, CCRPS offers a free ICH GCP course that thoroughly explains and clarifies the complex document.

The European Medicines Agency (EMA): In the European Union (EU), the EMA coordinates PV and drug safety throughout all clinical trial phases. They ensure that a drug’s effects are monitored even after they are on the market. In addition to ICH GCP, the EU uses Good Pharmacovigilance Practice (GPvP) to determine monitoring standards of drug sales.

The Food and Drug Administration (FDA): In the United States (U.S.), the FDA supervises the approval of pharmaceutical products. Specifically, the Center for Drug Evaluation and Research or CDER is responsible for handling PV. Within CDER, the Office of Surveillance and Epidemiology assembles medical officers and safety evaluators to oversee PV in their field of experience. Most officers and evaluators are medical doctors or pharmacists.

Marketed Health Products Directorate (MHPD): The Canadian Directorate assesses and regulates health product risks. They are composed of 6 different bureaus and offices, each with their own area of speciality. Together, the Directorate monitors adverse drug effects and makes regulatory decisions.

Pharmaceuticals and Medical Devices Agency (PMDA): Established in 2004, the Japanese regulatory authority PMDA supervises the safety of drugs from the lab to the market. Not only do they consult clinical trial professionals on clinical compliance, they also provide post-market safety measures and relief services for adverse health effects.

Since drug safety is important for patient health and safety around the world, there are career opportunities for PV virtually anywhere. If you want to learn more about pharmacovigilance, please visit our website at CCRPS.Org. Our online Pharmacovigilance Certification guides new professionals to improve their qualifications and gain valuable insight. The course is curated by real clinical research professionals and flexible enough to fit any schedule. Moreover, for those looking to expand their career into clinical research coordination or clinical trials assistance, CCRPS offers comprehensive courses such as the Clinical Research Coordinator, Clinical Trials Assistant Training, CRA certification, Advanced Clinical Research Project Manager Certification, Advanced Principal Investigator Physician Certification, and Medical Monitor Certification.