Tagged with Romania

Pharma Legal Handbook An intro to the legal situation for preclinical and clinical trial requirements in Romanian Pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119.   1. Are clinical trials required to be…

Pharma Legal Handbook The legal framework for regulatory, pricing and reimbursement in Romanian Pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119.   1. What are the regulatory authorities with jurisdiction over…

Romania Mirela Iordan country manager of Pfizer Romania reveals some of her milestones, including integrating new acquisitions and setting up the first financial centre in Europe for Pfizer. She shares her insights on how the affiliate is working to maximise patients’ access to the latest innovations through patient assistance programs, early…

Romania With the 2019 acquisition of Celgene – one of the largest pharma acquisition in history – two of the sector’s most innovative oncology companies have joined forces to lead the charge against cancer. The combined entity is expected to rise in the global biopharma rankings, complete with a fresh new…

Romania According to a 2015 United Nations International Migration Report, since Romania joined the European Union in 2007, around 3.4 million Romanians have left the country in search of a better quality of life and economic opportunity.   In 2019, the number of babies born in Romania was approximately 182,000, making…

Romania While the dismal regulatory environment in Romania has negatively affected the innovators with the uncertain and lengthy regulatory approval timelines as well as the dreaded ‘clawback tax’ doubling over the past decade, the generics sector has argued that they are the ones that have borne the brunt of unfavourable industry…

Romania Stana Moisescu of Teva Pharmaceuticals Romania shares her insights on how to overcome unpredictability and inconsistency at the government level in Romania and why there needs to be a change in the country’s clawback tax. Moisescu shares news of upcoming launches of both innovative and generic products and the optimisation…

Romania Dan Minoiu, partner at Romanian law firm Mușat & Asociații, shares his insights into the main trends shaping the healthcare environment in Romania from a regulatory and legal perspective, the challenges currently facing his clients, and his hopes for the future of the country.   Our clients always stress how…

Romania Despite the challenging characteristics of the Romanian market, with a large population of nearly 20 million people and significant unmet medical needs, the country will undoubtedly continue to be strategic to multinationals in the region. This also means a consistent cycling of general managers, whether they are dispatched to the…

Romania Sévan Kaloustian shares his first impressions of the Romanian healthcare ecosystem and pharmaceutical market as newly appointed managing director of Janssen Pharmaceutical Companies of Johnson & Johnson Romania. Kaloustian outlines his intention to maintain the strategic position of Janssen as a key player in Romania, working to facilitate the access…

Romania Arina Gholmieh introduces the Romanian affiliate of Egis, a leading pharma manufacturer in the Central and Eastern Europe (CEE) region. Gholmieh highlights the difficulties that pharma companies, and especially generic producers, face in Romania: clawback tax, pricing methodology, and a low penetration rate of biosimilar medicines.   We are passing…

Romania Quite unfortunately, Romania has some of the highest infant mortality and maternal mortality rates in Europe, and even more worrying, the downward trend seems to be continuing, most notably with significant measles outbreaks occurring in the country every year since 2016. Part of this distressing phenomenon relates to a growing…