Tagged with Egis

Europe Last year the European Commission (EC) came out with a proposal to reform the EU’s core pharmaceutical legislation, aiming to address affordability, accessibility, and availability, among other objectives. One of the key changes proposed was reducing the EU’s baseline regulatory data protection (RDP) timeline, a plan that pleased the generics…

Hong Kong Former Hong Kong SAR Chief Executive CY Leung  discusses Hong Kong’s unique positioning within the Greater Bay Area and the importance of its openness, international business mindset, and strong sense of social responsibility in maintaining its global relevance. Leung also reflects on Hong Kong’s response to political and economic uncertainties…

Europe PharmaBoardroom was delighted to attend DIA Europe 2024 in Brussels earlier this month, bringing together a veritable who’s-who of the European and global regulatory community. The politicians, regulators, payers, patient advocates, industry representatives, and service providers in attendance were treated to a three-day buffet of engaging panels and townhalls with…

Europe Rainer Westermann of venture capitalist coalition Life Sciences Acceleration Alliance reviews the potential impact of the EU’s general pharmaceutical legislation on the investment climate for the EU life sciences sector. Building on his insights from last year, Westermann urges stakeholders to seize the opportunity caused by a delay in the…

USA US Congress has highlighted Chinese biotechnology firms, including giants WuXi and BGI, as posing a risk to the country’s national security. PharmaBoardroom takes a look at why the US is now targeting these companies and the potential impact of a proposed US Biosecure Act on US-China biotech ties.   Protecting…

Europe The European Federation of Pharmaceutical Industries and Associations (EFPIA) has elected a new president and vice presidents who have set out a key priority for their term: a series of amendments to the proposed European Commission (EC) pharmaceutical legislation reform, which the organisation has warned will further accelerate the loss…

Europe Alexander Natz of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) casts his eye over the potential effects of the upcoming EU Pharmaceutical Legislation for small- and medium-sized enterprises in Europe. Natz feels that Europe is at a crossroads in terms of its positioning as a driver of innovation and calls…

Europe Based on current discussions by the European Commission, launch conditionalities would not account for the distinct nature of small and mid-sized companies, OMPs and ATMPs. EUCOPE’s Alexander Natz breaks down this aspect of the revision of the general pharmaceutical legislation and why it would prove unsustainable for smaller companies and…

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 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…

Hungary After years of planning and collaboration with various stakeholders, in 2017 the Hungarian government launched the Electronic Health Service Area (EESZT): a centralized database of patient records and health interventions with the aim of bringing Hungary in line with other countries at the forefront of digital healthcare   The Road…

Russia Nadezhda Fedotova and Andrey Zelenin of Lidings law firm gives an update on recent amendments to the labeling legislation for medicines in Russia, their potential impact on the Russian pharmaceutical industry, and the numerous uncertainties still remaining.   Despite the time moving up to January 1, 2020, it seems impossible…