Italy The Italian system requires drug companies to go through approvals at a national level with the Italian Medicines Agency (AIFA), only to then confront the country’s 21 regional authorities who independently manage the budget for territorial pharmaceutical expenditure and evaluate regional access. According to many industry stakeholders, this lengthy process…
Bahrain Dr Mariam Al Jalahma, CEO of the Kingdom of Bahrain’s National Health Regulatory Authority (NHRA) remarks on the healthcare transformation that led to the creation of the NHRA and explains the Bahraini regulatory body’s comprehensive responsibilities that range from the registration and pricing of essential medicines to the approval of…
Hong Kong After a record year of new biotech listings in 2021, the Hong Kong Stock Exchange (HKEX) has seen a significant drop-off in the first eight months of 2022. The exchange went from 20 new listings last year to only four this year, with just three full months of 2022 remaining…
Italy Tiziana Mele, managing director of Lundbeck Italia, explains the impact of COVID on mental health care from the perspective of a company dedicated to brain health, outlines the Italian operation that includes both commercial and production capacities and shares Lundbeck’s support of independent clinical trials in the country. At Lundbeck,…
Middle East & Africa Apart from a maturing regulatory environment and the expansion of healthcare coverage across the region, a number of other factors are contributing to the evolution of the MEA pharma market. Results from the second wave of a PhRMA-commisioned IQVIA market access study covering Saudi Arabia (KSA), UAE, Kuwait, Lebanon, Jordan,…
Italy Guerbet’s Alessandro Bocci – General Manager Italy & Iberia – describes the nearly 100-year-old company’s firm position in the field of contrast media for radiology and its plans for developing a portfolio in artificial intelligence (AI). In addition, he outlines how the Italy, Spain and Portugal cluster made its way…
Pharma Legal Handbook 1. Are biosimilar medicines considered the same as generic medicines in your country? No. At present, a “biosimilar” is not the same as a generic drug. Previously, some biological marketing authorization licenses were obtained by using the same registration pathway of generic medicines (i.e., without the submission of pre-clinical or…
Global Pharma companies no longer view digital as a “nice to have” add on, but as an integral part of their business, yet there are still quite a few hurdles to overcome. Insights from pharma industry digital transformation leaders. Industry is on a dedicated and focused journey to leverage data and…
Middle East & Africa Fujifilm’s managing director for the Middle East, Michio Kondo, outlines the company’s move from products to comprehensive healthcare solutions, and how this transformation aligns with the GCC region’s view on the future of healthcare. In addition, Kondo comments on the recognition of the made-in-Japan brand, the implementation of AI in…
Spain Sanofí’s general manager for Spain, Margarita Lopez Acosta, comments on the company’s “Play to Win” strategy, the presence of the French giant in Spain and the leading role of the country in clinical trials. She also explains possible solutions to the challenges around access to innovation in Spain. Both the…
Global Merck Group’s Vice President Global Market Access & Pricing Strategic Planning, Marco Rauland, takes a look at recent advancements in Machine Learning and Artificial Intelligence and how these technologies can offer a sophisticated and flexible approach not only to predicting drug pricing, but also to estimating market access with different…
Taiwan With a healthcare system that is emerging as one of the most advanced in Asia and legislation that aims to support the biomedical industry, Taiwan’s pharma, biotech and medical devices markets have seen steady growth in recent years. Hecho conVisme Infographic Maker Hecho conVisme Infographic Maker Hecho conVisme Infographic Maker…
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