Biosimilars are biological medicines, the active substances of which are highly similar to those of biologics that have already been authorized. As for any other medicine, the applicant of the biosimilar marketing authorization must submit a risk-management plan (RMP)/pharmacovigilance plan. The pharmacovigilance plan should take into account risks identified during product development, the pot...

The development of vaccines is one of the most important public health achievements. However, as the incidence of vaccine-preventable diseases has decreased, the general public has become increasingly concerned about vaccine safety. Vaccine safety is evaluated extensively through animal safety studies, clinical trials, and post-licensure surveillance. Safety monitoring in post-licensure surveil...

Pharmacovigilance plays a key role in the healthcare domain through the assessment, monitoring and discovery of interactions amongst drugs and their effects in the human organism. However, technological advances in this field have been slowing down over the last decade due to miscellaneous legal, ethical and methodological constraints. Pharmaceutical companies started to realize that collaborat...

OBJECTIVE To assess the pharmacovigilance awareness among the healthcare professionals in a teaching hospital in Northern India. MATERIAL AND METHODS A questionnaire which was suitable for assessing the basic Knowledge, Attitude and the Practice (KAP) of pharmacovigilance was designed and distributed among 100 doctors of the Punjab Institute of Medical Sciences (PIMS) Hospital, Jalandhar, Pun...

INTRODUCTION In Turkey, pharmacovigilance began in 1985. A fully structured adverse drug reaction (ADR)-reporting system was established with the publication of the first pharmacovigilance regulation in 2005. Subsequent regulation published in 2014 brought further improvements to the system. OBJECTIVE In this study, we aimed to analyse the ADR-reporting pattern in the context of the first pha...

Seasonal malaria chemoprevention (SMC) campaign is known to reduce malaria-related morbidity and mortality among children aged 3 -59 months in the Sahel regions of Africa. However, success intervention may be adversely affected by absence a robust pharmacovigilance system monitor safety. This paper aims describe our reporting experience during campaigns conducted across seven states Nigeria 202...

In July and August 2014, the European Medicines Agency (EMA) organised two public consultations concerning European pharmacovigilance. These two consultations reveal a number of EMA proposals that are counterproductive to the objective of improving transparency over pharmacovigilance data. The EMA's proposals offer pharmaceutical companies an opportunity to participate in public hearings held b...

The implementation of a pharmacovigilance service compliant with the legal and regulatory responsibilities of clinical trial sponsors presents particular challenges for sponsors in a non-commercial setting.In this paper we examine these challenges in detail. We identify and discuss the key steps in the development of a pharmacovigilance service within a public health service and university sett...

Pharmacovigilance is a corrective process originating in pharmaco-epidemiology. The 1997 Erice Declaration, presented at the World Health Organisation, became the basis on which the concept was implemented internationally for conventional systems of medicine. The increasing international acceptance of Ayurveda, led regulators to implement a similar program for Ayurveda, particularly as some med...

We read with great interest the article by Hisham AlJadhey et al1 regarding the major challenges facing pharmacovigilance in the Kingdom of Saudi Arabia (KSA). We have been associated with pharmacovigilance in Nepal for many years. The first author was involved with the establishment and the operation of 2 regional pharmacovigilance centers in the country, and the second author is the chief pha...