Pharmacovigilance requirements in Algeria – Interesting Facts!
Algeria is a North African country located somewhat close to the European Union. The Centre National de Pharmacovigilance et de Materiovigilance (CNPM) updated the Pharmacovigilance guideline in 2019, and it is more or less on the lines of GVP, with some minor alterations. Some examples include: 1. ICSRs · Domestic Serious – 15 Calendar Days […]
Liechtenstein is a small country that is located between Austria and Switzerland. Liechtenstein is not a part of the European Union, but it is a part of the European Economic Area (EEA) and the European Free Trade Association (EFTA). Courtesy: Google Maps Switzerland is a part of EFTA, and not a part of EEA. On […]
In recent times, the pharmaceutical industry has been witnessing quite a few Mergers and Acquisitions (M&A) as companies want to grow organically as well as inorganically. Indeed there is intense competition in this field and companies want to sustain competition, and want to remain ahead of their peers. Considering the growing regulatory expectations, companies need […]
The ‘lot many’ months of COVID-19 lockdown, has allowed some people to answer these ‘simple’ questions: “What is it that gets you up every morning and keeps you going?” or “what is my personal legend?” and thankfully I am one of those fortunate ones who has found an answer to these simple questions! I still […]
Ghana joined the WHO International Drug Monitoring Program in November 2001 as the 65th member of the program and the first country from West Africa to get enrolled. Ever since the Pharmacovigilance guidelines have well evolved. These guidelines are even updated from time to time. The MAH is required to report domestic serious reports within […]
The COVID-19 situation made it possible for regulatory agencies globally to explore all the four facets of unlicensed medicines, namely: 1. Emergency Use Authorization 2. Compassionate Use 3. Named Patient Basis 4. Expanded Access Program The first and foremost thing to understand is that the medicine in question can fall into any of the following […]
“The best way to survive an FDA inspection is to be prepared for it!” An FDA Pharmacovigilance inspection is generally unannounced. However, if it pertains to a foreign/ Non-US site, it is likely to be a pre-announced one. What are the types of FDA Pharmacovigilance inspections? 1. Post Marketing Adverse Drug Experience (PADE) 2. Risk […]
Whenever we think about Pharmacovigilance in France, two things come to mind. First is the French Imputability Method of Causality, and the second is ‘Exploitant.’ The concept of ‘Exploitant’ is specific to France. Under the French legal framework, a Marketing Authorization Holder (MAH) which wants to market a medicinal product in France, needs to hold […]
Let me start off by asking a couple of questions… 1. How do you handle expired medicines at the home, office or in a healthcare set-up? 2. Can Pharmacovigilance affect only human beings and animals)? I recollect many instances where I have, or some near or dear one has discarded old and unused medicines by […]
Not all companies would consider setting up affiliate offices/ subsidiaries in all countries where they wish to operate or commercialize products. The Pharma company may consider nominating a distributor or business partner in such scenarios. Besides, companies may even consider co-marketing arrangements in countries already operating, using own-label or private-label supplies or other means such […]