Tagged with Regulator

Spain Faus & Moliner Abogados is a Spanish law firm that has been specializing in pharma and life sciences law since 1997. Founding partner Jordi Faus explains how having a comprehensive knowledge of the industry has become the firm’s competitive edge. He discusses the push for regulatory innovation among European regulators,…

Vietnam Despite a decline in pharmaceutical sales during the COVID-19 pandemic, Vietnam is among the 17 countries with the most rapidly growing pharmaceutical industries in the world, as reported by nganhduoc.vn in its 2022 pharma industry forecast. With a market value of some USD 10 billion in 2020, according to another…

Canada Biosimilar uptake initiatives are gaining traction across Canada and have already been implemented in several provinces. Dara Jospé and Lina Bensaidane of Fasken examine the impact of these policies on patients, prescribers, and pharmacists thus far, and the implications should non-medical biosimilar switching become a nationwide norm.   In the…

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…

Mexico Mexico’s pharma market, the second largest in Latin America and among the top 15 globally, is set to top USD 13 billion in sales by 2028. Despite the encouraging numbers, some industry insiders are bemoaning the current government’s healthcare missteps along with the country’s low public spending and regulatory hurdles.…

Egypt The head of the Pharmaceutical Chamber of the Federation of Egyptian Industries, Gamal El-Leithy, shares his view on the positive developments driving the growth of Egypt’s pharma market, including the creation of an independent regulatory body and a procurement agency. In addition, he analyses the country’s response to the COVID-19…

Global Sarah Pope Miksinski, executive director/CMS regulatory affairs, and Gregory Rullo, senior director regulatory affairs, at AstraZeneca discuss the need for common ground among regulators and industry when it comes to patient centricity and for strategic leadership to address differing regulatory control-strategy requirements. In today’s increasingly complex and intricate pharmaceutical landscape,…

Italy Domenico Mantoan, General Manager of AGENAS, the Italian National Agency for Regional Health Services, discusses the role of the agency in Italy’s decentralised healthcare system, the National Recovery and Resilience Plan’s aim to improve territorial inequalities, and the National Outcomes Program managed by AGENAS on behalf of the Ministry of…

Americas Collaboration, convergence, and other best practices have been at the center of discussions related to the regulatory environment in Latin America and the Caribbean, including DIA’s Latin America Regulatory Conference (LARC) 2022, where voices from global regulators, regional and international organizations, industry, and academia discussed the strategies supporting current practices and…

Asia-Pacific Writing in the June edition of DIA’s Global Forum magazine, Ellen Sem, Fengyun (Vicky) Han and Annetta C. Beauregard from Janssen Pharmaceutical Companies of Johnson & Johnson, outline the real-world data (RWD) and real-world evidence (RWE) regulatory landscape in Asia Pacific.  Real-world data (RWD) and real-world evidence (RWE) have played an…

Italy Giorgio Palú, President of the Italian Medicines Agency (AIFA) helps us understand how the agency works, explains the criteria they use to evaluate innovative medicines and tells us about AIFA’s independent research program. AIFA has always favoured innovation and, in this context, has defined specific criteria with the aim of…

Europe Nick Sykes of Pfizer discusses the European Commission’s intention to “future-proof” the EU regulatory system and the suggestions for changes that were discussed througout the DIA Europe 2022 meeting. From the May edition of DIA’s Global Forum magazine. In its Pharmaceutical Strategy, the European Commission intends to “future-proof” the EU…