Everyone in the pharmaceutical should have a basic understanding of Drug Safety and Pharmacovigilance for FDA compliance.

Drug Safety and Pharmacovigilance is there throughout every step of the drug development, but there is so few information with the basic fundamentals available to help new people within drug safety or anyone who has an interest to want to learn the basics.

One of the reasons for good clinical practice (GCP) is to protect the subjects in a research trial. In all research the subjects’ well-being should be paramount Safety checks, procedures, and reporting are fundamental to any research study involving human subjects. This includes the timely detection and management of, adverse events (AE), serious adverse events (SAE), adverse reactions (AR), and suspected unexpected serious adverse reactions (SUSAR). In addition, excellent record keeping, follow-up, and reporting are essential so that appropriate decisions can be taken relating to study participants as well those which help steer the course of the study, based on emerging safety information.

One of the most important aspects of clinical research is ensuring the safety of new drugs, treatments, etc on patients. This is called pharmacovigilance or drug safety compliance. This safety aspect is monitored, implemented, and complied with in two ways. Firstly, the sponsor of the clinical research, usually a pharmaceutical organization, conducts drug safety tests at all the stages of the clinical trials they conduct wherever it is required by law. They also implement drug safety protocols at stages of the clinical research study voluntarily too. The other way in which pharmacovigilance compliance is ensured is by the laws and guidelines given by the regulatory authorities like the Food and Drugs Administration (FDA) in the US.



The sponsor of a clinical research study or trial has his major aim as the determination of the efficacy of a new drug on a human condition by experimenting on patients diagnosed with the condition. It is the legal, moral, and ethical responsibility of the sponsor to also ensure the experimentation is conducted in a safe manner and does not cause any adverse or fatal consequences to the patients’ lives.

In order to do this, the sponsor initially starts a clinical research study/trial by designing a research protocol. This protocol is designed according to the guidelines provided by the regulatory authority. The guidelines describe in detail how sponsors can ensure that their trials or studies comply with the required pharmacovigilance regulations. Since reporting of adverse events is considered to be the most common activity performed by sponsors with respect to pharmacovigilance in clinical trials, the guidelines also explain how the reports of adverse events during the trial are to be provided by the sponsor to the regulatory agency.


In the US, the FDA released a guideline document in 2005 titled the “Good pharmacovigilance practices and pharmacoepidemiologic assessment – Guidelines for Industry”. This document contains inputs from the US department of health and human services, along with the FDA’s two sister organizations – Centre for Drug Evaluation and Research (CDER) and The Centre for Biologics Evaluation and Research (CBER). This document helps prepare a pharmacovigilance plan and provide guidelines for actions to be taken when adverse events are reported.

The FDA compliance program guidance manual is another document that is used by FDA staffers. They used it to file investigational reports about various stages of the trials as well as adverse events in the field.

The 2005 guidance for industry document in E2E Pharmacovigilance planning is another regulatory document that details the steps to be taken by sponsors to formulate a pharmacovigilance plan for their study/trial. It also details the various pharmacovigilance methods that can be used.

The FDA’s “Introduction to Post-marketing drug safety surveillance: pharmacovigilance in FDA/CDER” provides inputs for sponsors on pharmacovigilance guidelines to be complied with after the approval for a new drug is granted.

Individual case safety reports (ICSR) are another layer of compliance that regulatory authorities demand from sponsors. Sponsors need to report on the effects of the new drug or treatment of every participating patient and file them. They need to provide this to the FDA in order for the FDA to assess if the new drug has caused adverse events, whether it is effective or not, etc.

Drug safety and pharmacovigilance are two faces of a coin

If one were to describe the relationship between drug safety and pharmacovigilance the most concise way of describing it is by calling them as two sides of the same coin. The aspects of drug safety and pharmacovigilance are intricately and inseparably bound together. The whole purpose of pharmacovigilance is the assurance of drug safety. It is precisely to ensure drug safety, more than anything else, that pharmacovigilance has come into being as a discipline.

Pharmacovigilance (PV in drug industry parlance) is a means to ensuring drug surveillance across the entire process, right from procuring of raw materials to consumption and the effects of consumption. So, pharmacovigilance has to be implemented right across the chain of activities that go into drug manufacturing. It has to ensure compliance with regulation at all stages, namely before the product is manufactured, during the manufacture, and after it enters the market. It is an indispensable aspect of a Quality System and plays a central role in inspections and audits.

Drug safety and pharmacovigilance are tied together at the level of regulatory bodies. There are different PV rules for different markets. For instance, while the FDA has its own set of PV guidelines; the EU has its own. A clinician or drug company involved in drug safety and pharmacovigilance has to be aware of the regulations in the markets into which the company’s products are sold and has to abide by them.

In order to ensure drug safety, pharmacovigilance is carried out by agencies and governments across the globe in accordance with strict guidelines. Drug safety and pharmacovigilance pair together in a number of areas. These are some of them:

Clinical trial: The work of ensuring drug safety through pharmacovigilance starts at the stage of the clinical trial itself. Pharmacovigilance ensures that drug safety is built into the drug right at the clinical trial stage. PV sets out a number of processes and methods by which a pharmaceutical company involved in clinical trials has to go in order to ensure drug safety.

Marketing: PV is set out in the marketing stage of a drug, too. Drug safety brought about by pharmacovigilance is to be implemented at the marketing stage of the drug, including processes for its safe storage, handling and transit. Throughout all these stages, drug safety and pharmacovigilance guidelines are to be strictly implemented.

Governmental drug distribution: Drug safety and pharmacovigilance are also built in by governments in their interactions with each other. For instance, when the government of a country or an agency such as the UN is shipping drugs to another country to support a health program; utmost drug safety is ensured through the principles of pharmacovigilance.

Drug safety and pharmacovigilance in disease management: Several governments across the world, along with international agencies conduct disease control management or emergency handling across the globe, especially in developing countries. Pharmacovigilance is the means to ensure that the drugs administered at these programs are safe for human consumption.

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