Recent News
Countdown to launch of new EudraVigilance System
Final preparations for change-over to new system underway for go live date on 22 November 2017 On 22 November 2017, the European Medicines Agency (EMA) will launch a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area…
Read MoreExploring opportunities for collaboration between regulators and healthcare payers
European Medicines Agency and healthcare payer organisations held joint meeting on 19 September The European Medicines Agency (EMA) and European Union (EU) healthcare payers met for the first time on 19 September 2017 at EMA’s offices in London to explore synergies and foster mutual understanding and cooperation to help improve timely and affordable access of…
Read MoreFacilitating submission of post-approval data
EMA implements new submission form for post-authorisation measures The European Medicines Agency (EMA) has launched a new form to help marketing authorisation holders submit data generated to satisfy post-authorisation measures(PAMs) for centrally authorised products. PAMs require marketing authorisation holders (MAHs) to provide additional data on the safety, efficacy or quality of the medicine once it is authorised. They fall into several categories, depending…
Read MoreFDA improves access to reports of adverse drug reactions
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The Agency also is responsible for the safety and security of our nation’s food supply,…
Read MoreFDA’s Adverse Event Reporting System and new search tool
Medicines Development and Regulation in Africa
Africa is one of the world’s fastest-growing economic regions, with a rise in its pharmaceutical industry value from $4.7 billion in 2003 to $20.8 billion in 2013. Multinational pharmaceutical companies are increasingly active in drug production and clinical trials across Africa, and there is an increasing number of local companies engaged in medicines development and…
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