Tagged with Regulation,

Pharma Building on the continuous improvements of the Federal Commission for the Protection Against Sanitary Risk (Cofepris) over the last few years, its recently-appointed Federal Commissioner Julio Sánchez y Tépoz reveals his strategy to further strengthen and develop the Commission’s processes and international leadership, and foster a more transparent, technical, efficient…

Pharma The following chart illustrates the various bottlenecks restraining the development of France’s pharmaceutical industry, including lack of investment, fewer new molecules than other European countries, disappointing performance in biological drugs, and long waiting times for drug approval. Click here to read more articles and interviews from France, and to download the…

Pharma Dr. Lívia Ilku, director of Hungary’s main domestic pharmaceutical manufacturers’ association (MAGYOSZ), describes the current priorities of its member companies and the key factors for success in Hungary; specifically innovation and complying with regulatory standards. Given its more than 100-year legacy in the country, how has the pharmaceutical industry supported…

Pharma The Director of the State Institute for Drug Control in the Czech Republic highlights the Czech pharmaceutical industry as emancipated and points out their tremendous contribution to employment, export balance, the economy at large and to the patients. You assumed the position as interim director of the State Institute for…

Pharma Providing universal health coverage to the nation’s roughly 10 million citizens, Hungary’s National Health Insurance Fund (OEP) has one of the most comprehensive and complex structures in Europe. The organization’s Head of Pricing Support, Dr. Judit Bidló discusses the current mechanisms governing pharmaceutical reimbursements in Hungary, while also identifying the…

Pharma Veronika Ferencz, Sales and Marketing Director for Exeltis Hungary, discusses the evolving and expanding footprint of the company in Hungary, the challenges strict regulations on food supplements are causing, as well as the need for better recognition of women’s health as a therapeutic area. She also reflects on her own…

Pharma The executive director of the Česká asociace farmaceutických firem, the Czech Republic’s generic pharmaceutical association, elaborates on the code of ethics recently implemented and followed by all its members, which exceed the standards set in current legislation. Furthermore, he explains the implications for the industry of the ongoing EU-level discussions…

Pharma The general manager of IMS Health, Zsolt Szepesházi, explains how the current limitations of Hungary’s healthcare system have shifted the way that pharmaceutical companies approach the market, placing a much greater emphasis on value demonstration and patient-level data. You have been General Manager at IMS Health for 8 years. During…

Pharma Genfit’s Jean-François Mouney speaks about responding to high unmet medical needs in inflammatory and metabolic related diseases. With the increase in obesity related diseases, Mouney discusses their lead pipeline product: Elafibranor, the new orphan blockbuster drug aimed at curing NASH; nonalcoholic steatohepatitis and other related diseases.   As an entrepreneur…

Pharma Novo Nordisk Hungary GM Zsolt Jozsa highlights the growing prevalence of diabetes in Hungary, the gap in treatment options that the company is striving to close with Tresiba and Xultophy, and the limitations of Hungary’s regulatory framework. Zsolt, you took over the helm of Novo Nordisk Hungary in 2012, after…

Pharma Janssen Czech Republic’s MD reviews his longstanding career within the company and highlights how founder Dr. Paul Janssen’s legacy still influences operations today. He also compares the Czech regulatory environment with those of its regional neighbors and finds that there is little ground for fair comparison. You have been with…

Pharma Concerted efforts are, at last, being made to redraw the rulebook and tidy up a local regulatory landscape long renowned for its torpor, dysfunction and ineffectuality. The Egyptian pharmaceutical market is currently regulated by the Ministry of Health itself, with all issues related to pharmaceuticals falling under the responsibility of…