Outsourcing pharmacovigilance and allocating drug safety and regulatory activities can significantly reduce costs and workload for each marketing authorization holder (MAH). However, overall responsibility and monitoring of the pharmacovigilance system remains the responsibility of the MAH and the EU QPPV. In particular, it is the MAH`s responsibility to properly receive the process and expedite reports on adverse events and other safety reports if necessary. Although all pharmacovigilance activities are outsourced, overall responsibility lies with the MAH. The legal and regulatory responsibility for any failure of a pharmacovigilance provider to properly comply with pharmacovigilance legislation rests with the MAH, not with the company to which pharmacovigilance has been outsourced. If a journalist does not remember the name of the medication he took during an adverse event, that would not be a valid case. This approach also applies to adverse events. If a patient indicates that he or she has experienced “symptoms” but cannot be more concrete, such a report could be considered technically valid, but will be of very limited value to the company`s pharmacovigilance department or to drug control authorities.  Information received from patients and health care providers on pharmacovigilance agreements (VPAs) and other sources, such as the medical literature, plays a crucial role in providing the data needed for pharmacovigilance. To market or test a drug in most countries, data on adverse events obtained by the licensee (usually a pharmaceutical company) must be submitted to the local drug monitoring authority. (See reports of adverse events below. Given the inherent difference between drugs and medical devices, the vigilance of medical devices also differs from that of drugs.
To account for this difference, a classification system has been put in place in some countries to ensure that the risk of failure is linked to the different categories of devices. Aircraft classes are generally performed on a scale of 1-3 or 1-4, with Class 1 being the least likely to cause significant damage by default, compared to classes 3 or 4, which are most likely to cause significant damage in the event of equipment error. An example of a device in the “low risk” category would be contact lenses. An example of a device in the “high risk” category would be the pacemaker. Pharmaceutical regulators play a key role in national or regional surveillance of pharmacovigilance. Some of the agencies concerned are listed below (in order of expenditure for medicines in 2011 by the IMS INSTITUTE for health care information).  Pharmacovigilance has its own unique terminology, which is important to understand. Most of the following terms are used in this article and are specific to drug safety, although some are used by other disciplines within the pharmaceutical sciences as well. Established in 1992, the Pharmacovigilance Society, India, is a partner of ISoP. The Boston Society of Pharmacovigilance Physicians is one of the local societies.  The following organizations play a key role in the overall monitoring of pharmacovigilance. CIOMS, part of WHO, is a global think tank that, through its working groups, provides guidance on drug safety issues.
[Citation required] CIOMS establishes reports that will be used as a reference for the development of future drug regulation policies and procedures, and over the years, many strategies proposed by CIOMS have been adopted. [Citation required] The themes covered in these reports are: current challenges in pharmacovigilance: pragmatic approaches (CIOMS V); management of safety information from clinical trials (CIOMS VI); Development Safety Update Report (DSUR): harmonization of the format and content of periodic safety reports during clinical trials