Provision of healthcare is a key topic globally with increasing populations worldwide, increasing healthcare system costs, multiple humanitarian crises, and supply chain concerns. Two weeks ago in Dublin, Medicines for Europe brought together industry leaders and experts to discuss better access to medicines in hopes of addressing at least some these issues. Generic medicines play […]
After many years of discussion and much preparation, today is the day the revised Annex 1 takes effect, August 25, 2023. Have you reviewed the revisions, considered any gaps in your organization’s operations, and developed action plans to mitigate or remediate those gaps? Do you have a complete view of your firm’s compliance with the revised Annex 1? […]
The European Commission, the European Medicines Agency (EMA), and national competent authorities have recently issued an updated Question and Answers document on Regulatory Expectations for Medicinal Products for Human use during the COVID-19 Pandemic. The guidance can be found here. The guidance covers the following topics: Issues related to marketing authorizations, marketing authorizations procedures Manufacturing, […]
The COVID-19 pandemic is sweeping the world and companies and regulators are working hard to keep up with the increased demand for drugs and devices to treat the disease. Certain products used to treat COVID-19 patients are at risk of shortage due to this increased demand. Most notably, in the EU (which is a few […]
