Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 1. Has an essential or priority drug list been published in your country? (If so provide the link) Yes. In Brazil, the National List of Essential Drugs (“RENAME”) provides the selection and standardisation of…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 1. What is the definition of an orphan drug in your country? There is no specific definition for orphan drug in Brazilian current rules. However, we understand that it corresponds with the definition of rare…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 1. What is the definition of a vaccine in your country? As per ANVISA Resolution RDC 55/2010, vaccines are immunobiological drugs which contain one or more substances (antigens) that, when injected into an individual, stimulate…
Portugal Diabetes is a rising threat to the Portuguese people, the country’s healthcare system, and its economy. Portugal’s National Diabetes Observatory observed that 1.1 million Portuguese people between the ages of 20 and 79.5 (out of a total population of just 10.3 million) were living with diabetes in 2021. This…
Global Pharma is rushing to adopt AI-driven tools in the hope of revolutionizing everything from drug discovery to clinical trials, regulatory submissions, and marketing efforts. While AI is the technology du jour, Saskia Steinacker, senior VP, global head strategy and digital transformation at Bayer, argues that successful AI implementation within Pharma…
Global Drawing inspiration from Quentin Tarantino’s directorial breakthrough in the early 1990s, Blue Spoon Consulting’s John Singer explores the pharma sector’s urgent need for a strategic overhaul to ensure success and sustain growth amidst looming patent expirations. Lex is the flagship investment column of the Financial Times. Its commentaries, currently written…
China No longer a fledgling biotech, oncology-focused BeiGene, originally created in China in 2010 with the idea of carrying out world-class research there, has since expanded its global reach and garnered approvals for its therapies Brukinsa and Tevimbra. The company is on a growth trajectory with product sales reaching USD 2.2…
LatAm An overview of some of the biggest stories from Latin American pharma and healthcare, including Brazil’s rollout of dengue vaccines following a sharp increase in cases; the Brazilian regulatory agency ANVISA’s strategy to become a WHO-listed authority andAspid Pharma’s agreement with Institute for Research on Obesity of the Tecnológico de…
Saudi Arabia Dr Dalia Samra-Rothe highlights the role of AHK in facilitating German companies’ entry into the Saudi market, the significant economic transformation and opportunities in Saudi Arabia, and the importance of cultural awareness and preparedness when doing business in the country. [Saudi Arabia] is undergoing a truly remarkable transformation, unlike…
Portugal Novo Nordisk’s spectacular ascendancy in 2023 has meant that its country managers across the world have had to embrace scrutiny and press coverage like never before. In its centenary year, the Danish firm’s new generation of obesity drugs supercharged revenues to around EUR 30 billion, a 30 percent hike…
India Shailesh Siroya explains the rationale behind Bal Pharma’s strategic focus on niche products within the API segment, avoiding the broader, more competitive commodity markets and enabling it to establish a significant global presence. Siroya also outlines how Bal Pharma has evolved from its initial focus on the export market to…
India Multinational life science firms have been present in India for decades. However, they have often eschewed bringing their latest products to a country that has long prioritised affordability above innovation. Now though, as India’s GDP and market value soar and the policy environment shifts towards prioritising the domestic development of…
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