Tagged with HE

Pharma Legal Handbook 1. In addition to the clinical data obtained through clinical studies please list the data required for: a. Market approval Generally speaking, for getting a marketing authorization of a medicinal product, the applicant needs to provide sufficient information to demonstrate that the relevant product fulfills the established quality requirements, is…

Pharma Legal Handbook 1. Are there any Managed entry agreements in place in your country? (If so, please list them) Yes, there are managed entry agreements in Spain. The most frequent Managed Entry Agreements (MEAs) are financial and performance-based agreements (both at patient and population level).   2. Describe the fundamentals of the…

Pharma Legal Handbook 1. Please describe the main cost containment policies in place in your country and their fundamental principles: a. Pricing and impact of generic/biosimilar approval The entry of generics/biosimilars into the market affects the price of original drugs by three main mechanisms: (i) homogeneous groups (“HG”), (ii) reference groups (“RG”), (iii)…

Pharma Legal Handbook 1. Has an essential or priority drug list been published in your country? (If so provide the link) Yes. Three types of lists have been published by the AEMPS: “Essential medicinal products”: according to the WHO definition, these are the necessary medicinal products for a basic health system. “Critical medicinal…

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 The Moroccan National Social Security Fund (CNSS) has taken on a transformational mandate in recent years, spearheading the highly ambitious national campaign to expand universal health insurance to the entire Moroccan population. In a wide-ranging and in-depth conversation, CNSS Director General Hassan Boubrik lays out the scope and scale of…

LatAm A roundup of some of the latest news from Latin American pharma, including Acino’s acquisition of M8 Pharmaceuticals; AstraZeneca’s growth in Mexico; Neuraxpharm’s expansion into Brazil and Mexico, and Columbia’s decision to issue a compulsory license for GSK/ViiV’s HIV treatment.   Colombia set to issue a compulsory license for an…

UAE Drawing on two decades of experience within Bayer Consumer Health Middle East, and now as VP and head of the firm’s Middle East/Pakistan Cluster, Mohamed Galal discusses the transformative impact of the COVID-19 pandemic on the pharmaceutical landscape, Bayer Consumer Health’s strategic outlook in a region where healthcare awareness is…

Morocco Lamia Tazi, chairwoman of the board and CEO of Sothema and VP of the Moroccan Federation of the Pharmaceutical Industry (FMIIP), walks us through the over 40-year-old family-owned Moroccan company’s heritage as well as some of its recent advances such as the launch of its own range of oncology treatments.…

Global The global contract research organization (CRO) market is estimated to be worth USD 76.6 billion in 2023 and is projected to reach USD 127.3 billion by 2028, growing at a CAGR of 10.7% from 2023 to 2028. Much of this growth is due to the need for novel clinical trial…

Global Mohamed Meshref M.D, PhD is a Professor of Oncology at Cairo University and Regional Medical Director at Boehringer Ingelheim for India, Middle East, Turkey & Africa (IMETA). Here, Prof. Meshref discusses the importance of an ‘early medical affairs mindset’ within the pharma industry whereby medical affairs personnel engage much earlier…