- EMA: PRAC concludes review of Zydelig and issues updated recommendations for use
According to the information published on its’ website, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of Zydelig.
- Abbott gains U.S. endorsement for body-absorbable stent
As reported in media, U.S. health regulators approved a stent by Abbott Laboratories that is the first designed to be absorbed into the bloodstream after it is implanted.
- A new drug for treating Parkinson's disease was approved in the European Union (EU)
According to media reports, patients could get access to a new treatment option from Portugal’s largest drugmaker, Bial.
- EMA: Infringement procedure against Roche
As per the information posted on its website, the European Medicines Agency (EMA) has concluded its second inquiry within the framework of its infringement procedure against Roche.
- MoH: Newly issued draft order for updating Annex 1, Order no. 810/2015
The draft order was recently posted for public debate in the Legislative Transparency Section of the Ministry of Health’s website until July 25th, 2016.
- MoH: Central and Eastern Europe seeking to unite to ensure access to medicines for 124 million citizens
Given that expenditures on medicines in Central and Eastern Europe (CEE) sum up between 14% and 24% of total expenditures in the health system, health ministers from 10 countries met in Sofia to seek solutions of inter-state cooperation to overcome the challenges of access to medicines.
- NMMDA: Important announcement for wholesale distributors
The National Medicines and Medical Devices Agency (NMMDA) has recently informed on its website with regard to Czech distributor, WebCash s.r.o.
- Following changes introduced in the new Framework Agreement
Detailed the changes introduced in the Framework Agreement which will pass into legislation at the beginning of July 2016.
- MoH: Changes introduced in the new Framework Agreement
Detailed changes introduced in the Framework Agreement which will pass into legislation at the beginning of July 2016.
- EC: Clinical trials - Major developments
The European Commission calls for public consultation on "Risk proportionate approaches in clinical trials".
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