The European Medicines Agency (EMA) has released a list of standardized terms describing medical events it says will be used by the agency and other European regulators to identify suspected adverse events. EMA says the list will assist it and other regulators to prioritize the review of suspected adverse events that “deserve special attention, irrespective…
The government has allocated around 235 billion forints (EUR 754.6m) towards the first phase of hospital development and upgrades planned in the capital which are scheduled to begin at the beginning of next year at the latest, the government commissioner for hospital developments told daily Magyar Idők on Saturday. Most of the funds, around 185…
Based on the WHO definition pharmacovigilance is “scientific research related to the detection, assessment, understanding and prevention of adverse reactions or any other problems associated with medical drugs.” The ” thalidomide tragedy” caused creation of pharmacovigilance in EU. During just a few years of existing on the drug market, thalidomide became the cause of birth…
Belarus: Decree no 228 of 21 June 2016 establishes new rules for pricing of pharmaceuticals, medical devices and medical equipment (“medical products”). The new rules entered into force on 1 July 2016. We are glad to introduce you the most important changes. 1. Sale prices of medical products produced in Belarus and estimated sale prices of…
Sales of mid- and high-priced drugs in Russia are steadily declining, due to the ongoing economic stagnation in the country and the consequences of the financial crisis, reports The Pharma Letter’s local correspondent. According to a recent report, published by the Russian Ministry of Health, such negative trends force Russian patients to shift to cheaper…
Prague, 20 June 1016 – The Prague office of Baker & McKenzie recently hosted the latest in a series of workshops on hot topics and issues that pharmaceutical companies face when doing business in the Czech and Slovak markets. As of 1 July 2016, the newly adopted Contracts Registry Act will come into force, which…
Patients and clinicians need greater regulatory transparency to make informed decisions about treatment. Medical devices approved first in the European Union (EU) are associated with a greater rate of safety issues, finds a study published by The BMJ. Clinical trial results for many new medical devices that could guide treatment decisions also remain unpublished or…
The PSUR repository is a single, central platform for PSURs and related documents to be used by all regulatory authorities and pharmaceutical companies in the EU. The PSUR Repository provides an important simplification for marketing authorisation holders allowing them to send all PSURs and related submissions to a single recipient. It also facilitates the assessment…
The BNT Baltic Pharma Law Survey 2015 provides actionable insights into the pharmaceutical regulatory and competition law, pricing, reimbursement and other requirements that are crucial for doing business in the Baltic states. PharmaLawSurvey2015_TheBalticStates
The European Council’s Permanent Representatives Committee and the European Parliament’s Environment and Health Committee on Wednesday endorsed the agreement reached on the continent’s new medical device and in vitro diagnostic (IVD) regulations, a day after the draft versions of the texts were released. Following a legal-linguistic review of the two documents planned for September, the Council…