Romania's regulator abolishes paper-printed SUSARs
This article was originally published in Scrip
Executive Summary
Romania's medicines agency (ANM) is abolishing double reporting (on paper and electronically) of SUSARs (suspected unexpected serious adverse reactions) in clinical trials. From September 1st sponsors are requested to submit the reports online only. If they are unable to do so, they must inform ANM’s pharmacovigilance department and set up a deadline when they will be able to provide electronic reports. The agency also reminded sponsors that it has started reporting to EudraVigilance, the European pharmacovigilance database. The requirements for electronic transmission of ICSRs (individual case safety reports) and SUSARs are available on its website.
You may also be interested in...
Poland's new law fixes prices and trade mark-ups of reimbursed drugs
Poland's president, Bronislaw Komorowski, has signed a reimbursement bill into the law which will come into force on 1 January.
Global pharma boosts business in Russia - Why Russia (introduction)
In the past two years, most multinational pharmaceutical companies announced plans to create production facilities in Russia. They had been ignoring such an opportunity for years, and there were reasons for that. They included risks to investments, administrative barriers, unclear regulations assuming various interpretations and corruption.
Russia's president Medvedev wants talks on trials mutual recognition with US and EU
Russia's president Dmitriy Medvedev has requested that his government start talks with the US and the EU on the mutual recognition of clinical trial results (including paediatric trials) and prepare proposals for corresponding amendments of existing regulations.