Pharma Legal Handbook 1. What is the definition of an orphan drug in your country? In Spain there is no particularity in relation to the definition of “orphan drug” derived from the Regulation (EC) No 141/2000. Under Regulation (EC) No 141/2000 a medicinal product shall be designated as an orphan medicinal product if…
Pharma Legal Handbook 1. What is the definition of a vaccine in your country? The AEMPS defines a vaccine as an antigen-containing preparation capable of inducing specific and active immunity in humans against an infecting agent or the toxin or antigen elaborated by it. Immune responses include the induction of innate and adaptive…
Morocco A highly experienced stalwart of the North African pharma industry, Amine Sekhri today heads up AstraZeneca’s operations in Morocco. In his latest PharmaBoardroom conversation, Sekhri shares his delight at the positive healthcare transformations taking place across Morocco and Africa, gives his insight into the market access landscape for AstraZeneca’s most…
Global Claudia MartÃnez, generic & biosimilar medicines programme manager at the Access to Medicine Foundation, draws from a recent AMF report to outline what more generics companies can be doing to ensure greater access to their essential products. Martinez argues that for people living in low-and middle-income countries (LMICs), generic and…
UAE MSD GCC’s Ashraf Mallak looks back on a “transformational” two years since his last PharmaBoardroom interview back in 2021, with the set up of a new regional office, a raft of new launches and expanded indications, and the landmark inclusion of its HPV vaccine on various national immunization programs. Mallak…
Morocco Fadela Benjelloun, executive director of LEMM, the association of multinational pharma companies in Morocco, looks back on the evolution of the Moroccan pharma market over the past three years, examines the access to innovation situation today, and the impact of the generational healthcare reform currently underway in the country. …
Hong Kong Novartis, one of the world’s largest biopharma companies, has secured approval and market access for two of its most advanced cell and gene treatments in Hong Kong. The firm’s territory head, Derek Chang, highlights how early access to innovative therapies in the Hong Kong-Greater Bay Area (GBA) can unlock winning…
Hong Kong AstraZeneca, the largest overseas pharmaceutical company in mainland China by sales, is also the market leader in Hong Kong and Macau, a territory overseen by General Manager Shan Wu. She outlines the fundamentals behind the company’s success in Greater China, how AstraZeneca is working to bolster Hong Kong’s innovation and…
Hong Kong Lawrence Wong outlines how reproductive medicine-focused Ferring Pharmaceuticals is serving the patients of Hong Kong as the city’s birth rates have plateaued, weighs in on why the establishment of a Hong Kong medicines regulator is a strategic imperative, and discusses how his firm is collaborating with colleagues in mainland China…
UAE Mohamed Ezz Eldin oversees Novartis operations in the UAE, Kuwait, Bahrain, Oman and Qatar. He outlines how the company’s strategy has evolved in the Gulf region following the spin-off of generics arm Sandoz and its now 100 percent focus on innovative medicines. Ezz Eldin also describes some of the key…
Global Merck KGaA’s Marco Rauland and Kaushal Kishore examine how artificial intelligence and machine learning can best be applied in pharmaceutical pricing and market access. Noting the significant uptake of such tools in other aspects of the pharma value chain, Rauland and Kishore speculate how they might come to revolutionise pricing…
Belgium RaDiOrg aims to support rare disease patients and patient organisations in Belgium, defend their interests, and raise awareness of what can be devastating and little-understood conditions. Director Eva Schoeters – who joined the patient advocacy field following the diagnosis of her son with a rare condition – outlines some of…
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