- EMA: Proposals to revise guidance on first-in-human clinical trials
Folowing a new press release published on the website of the European Medicines Agency (EMA), comments are invited on a concept paper on changes intended to support best practices.
- Medicines for Europe: European Health Ministers call for more competition in pharmaceutical markets
As stated in a press communique recently posted on its website, Medicines for Europe (formerly EGA) will engage rapidly with Health Ministers across Europe to implement the Health Council Conclusions on “strengthening the balance in the pharmaceutical system in the EU and its Member States”.
- The Ministry of Health (MoH) informs with regard to discontinuity of certain pharmaceutical products needed for surgery procedures
Given the concerns raised in recent months by health units with beds with respect to the discontinuity of pharmaceuticals absolutely needed for surgery procedures, the MoH has taken the necessary steps in conjunction with marketing authorization holders to ensure adequate and continuous stocks so that the needs of patients in Romania are covered.
- The Ministry of Health has a new State Secretary with primary responsibilities in drug policy
According to a press release recently posted on the website of the MoH, Ioana Ursu became State Secretary in the MoH.
- The National Health Insurance House (NHIH) informed with regard to the process of signing of addendums to contracts between health insurance houses and healthcare providers in the territory
According to the press release the signing of addendums to contracts with healthcare providers developed normally.
- Five major biosimilars are to be launched by Novartis unit, Sandoz by 2020
According to media reports, the plan is to launch five biosimilars of major oncology and immunology biologics across key global markets by 2020, potentially broadening access to treatment.
- NHIH informs with regard to auction on companies providing maintenance and technical support for the health card and platform
As reported on its website, the National Health Insurance House (NHIH) designated the company that provides maintenance and technical support for the National Health Insurance Card (CAES) as well as for the Health Insurance Information Platform (PIAS).
- NMMDA: the Register of statements of sponsorship activities for 2015, published
According to the announcement posted on the website of the National Medicines and Medical Devices Agency (NMMDA), the Register is for information purposes and opened for public consultation in general or to anyone provng a legitimate interest.
- IQWIG: Ticagrelor for prevention after myocardial infarction
The German Institute for Quality and Efficiency in Health Care (IQWiG) assessed the added benefit of ticagrelor for patients with acute coronary syndrome already in 2011 in its very first dossier assessment.
- IQWIG: Idelalisib in second-line treatment for CLL
As stated in a recent press release posted on its website, the German Institute for Quality and Efficiency in Health Care (IQWiG) already examined in 2014 in an early benefit assessment whether idelalisib offers advantages over the appropriate comparator therapy for patients with chronic lymphocytic leukaemia (CLL).
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