Interpretation of Pharmacovigilance Regulations

by | May 14, 2019 |

Pharmacovigilance (PV) or drug safety is defined as the science and activities that are related to the collection, detection, assessment, monitoring and prevention of side effects (ie adverse drug reactions [ADRs]) of the marketed drugs. The safety information about the drug remains limited during its pre-authorization process which results in many consequences. It is estimated that around 5% of hospitalized patients develop ADRs and millions of people even die due to ADRs. Now, it has become the 5th cause of death in Europe. Therefore, monitoring of ADRs of each marketed drug is crucial in each country. The PV activities provide evidence related to the use of poor-quality drugs, incorrect use of the drug, drug-drug interactions, and treatment failures, thus, encourage the confidence and trust of the public in the drugs.

For this, the World Health Organization (WHO) has implemented Programme for International Drug Monitoring (PIDM), which is a network of >150 countries for monitoring the ADRs for enhancing the safer and more effective use of drugs. The European Medicines Agency (EMA) has also implemented the Guideline on Good Pharmacovigilance Practices (GVP) for PV regulation in the European Union. As per these regulations, pharmaceutical companies have implemented the PV practices either during clinical research or during the post-marketing process.

Pharmacovigilance activities in clinical research

During the clinical research, the sponsor needs to submit the details of any originated adverse events (AEs) to the regulatory authorities within the specified time. Also, it is necessary to notify all AEs related to drugs to the ethics committees (responsible for ensuring human research is carried out in an ethical manner). All safety issues of the drug are reviewed by Drug Safety Monitoring Boards. Sponsors also need to provide information about analysis and summary of all the serious AEs, unique safety finding from preclinical studies, as well as evaluation of all benefits and risk of the drugs in their annual report.

Pharmacovigilance activities on the marketed drugs

Pharmaceutical companies conduct comprehensive drug safety audit for post-marketing drugs to evaluate their ADRs as per laws and regulations. For doing this, the sponsor needs to follow below main elements:

  1. Phase IV Studies: Post-authorisation safety and efficacy studies which include either disease management studies or pharmacoepidemiology studies.
  2. Risk Management Plan (RMP): This safety program includes main elements such as safety reports of both preclinical and clinical phases, PV studies to resolve the risk of the drugs, and also provide the best proposal (educational exercises or any communication programs for patients) to the regulatory authorities to resolve the AEs of the drug within specified period.
  3. Periodic Safety Update Report (PSUR): Includes safety overview of the drug along with its ADRs. It also provides solutions for safety risks and any regulatory requirement for marketed drugs. After launching the drug, the PSUR is created every 6 months for 2 years and then updated yearly for 5 years.
  4. Spontaneous Reports: Provided by Healthcare professionals or patients. It includes reporting both serious and non-serious reaction of the drug to local or national PV centers.

Even after implementing these programs, guidelines or practices for PV regulation on the marketed drugs, the WHO still faces various challenges. In the low and middle-income countries, pharmaceutical companies launch the new drugs gradually every year, but they do not assess ADRs due to lack of PV systems or poor growth in the PV systems. To overcome this, the WHO is continually improving the PV methods through Public Health Programs, reducing the technical barriers for management of ADRs and making it compulsory for pharmaceutical companies to check the ADRs for every new drug.


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