The Eprex®-pure red cell aplasia case of 1998 engendered the understanding the perhaps the safety associated with biosimilars cannot be extrapolated from the innovator medicine as in the case of generics. Although generics and biosimilars are similar in the manner that they are both permitted for marketing only after expiry of the patent of the […]
Pharmacovigilance for Biosimilars vs pharmacovigilance for generics Read More »
The International Conference on Harmonization of Technical Requirements for the registration of pharmaceuticals for human use, or the ICH, was formed to facilitate harmonization of requirements and procedures among member states to ensure safe, efficacious, and high-quality drugs reach the market. The founding regulatory members include the European Commission (EC) of Europe, the Food and
An overview on pharmacovigilance in Japan, USA, Europe Read More »
Overview Pharmacovigilance (PV) and post-market surveillance is important to capture the safety profile of a drug. The entire information on a benefit-risk ratio & safety profile is not known until or unless the drug has reached the market and been used in a larger, much wider population. Hence, a systematic approach in monitoring and evaluating
What do you need to know about aggregate reporting? Read More »
Overview A drug is authorized by an agency only when it demonstrates a positive risk management-benefit balance or safety profile for the target population. It is a key component of Pharmacovigilance (PV) to safeguard public health. However, information on drug safety gathered from monitoring clinical trials is limited and, at times, not relevant to the larger population
Components of a risk management plan in pharmacovigilance Read More »
A crucial part of pharmacovigilance (PV) and post-market drug safety surveillance are unsolicited adverse event (AE) reports from various stakeholders including patients, pharmaceutical organizations, and healthcare professionals. These are spontaneous reports and serve as important sources of safety information for a product. Regulatory agencies rely on spontaneous reports for post-market safety surveillance from which they
Social & Digital Media Sources in Drug Safety Read More »
Individual Case Safety Reports (ICSRs) are a key aspect of pharmacovigilance (PV) and post-market safety surveillance as they provide crucial safety information for an approved pharmaceutical product, and a holistic view of the safety profile of the drug, including its benefit-risk profile, which is important to mitigate patient harm. The main steps involved in ICSR
Challenges in ICSR processing Read More »
A signal is information that arises from single or multiple source/s that may suggest a potential causal association between a drug and event given that the causal relationship between drug & event were previously unknown or inadequately documented. These signals are used for risk-benefit evaluation of a product and emerging safety issues that would cause
Role and Importance Signal Management in Pharmacovigilance Read More »
Structured Product Labeling (SPL) was first introduced in 2006 by the US Food and Drug Administration (FDA) with the aim to enhance the communication of product, quality, and facility information to label submissions. The move to the electronic Extensible Markup Language (XML) format, compared to the PDF format, has further streamlined drug label review processes,
Structured Product Labeling Read More »
Regulatory authorities around the world conduct pharmacovigilance (PV) inspections to verify that marketing authorization holders (MAHs) and allied organizations maintain compliance with PV requirements, obligations, and relevant standards. This applies to products as well as processes. National competent authorities appoint inspectors to conduct these inspections which can be announced or unannounced. If the former, then
Medico-regulatory writing is an important part of regulatory affairs in the Pharmaceutical and Life Sciences industry. Regulatory standards are becoming more stringent in terms of data requirements as a result of ever-changing regulations. So, it is crucial to incorporate the most updated and precise medical information into regulatory applications for pharmaceutical product approval and to
Enhancing Medico-Regulatory Writing with Artificial Intelligence Read More »
