Tagged with Technology

Pharma Legal Handbook 1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? The main bodies in charge of HTA in Spain are the AEMPS, the MOH (particularly the DGCC) and the regional governments; all of such bodies acting in coordination through REVALMED.[1] Also note that, as…

Pharma Legal Handbook Before answering the questions in this Section VI, it is appropriate to make an important consideration. In Spain, at least up to the date of this publication, the HTA evaluation is carried out by public authorities, without the industry having to provide a specific HTA dossier with pharmacoeconomic studies of…

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…

Hong Kong Paul Tam, who serves as chair professor & VP at Macau University of Science and Technology as well as emeritus professor and honorary clinical professor of surgery at the University of Hong Kong, has made important contributions to advances in paediatric minimal invasive surgery, genetics, and regenerative medicine of birth…

Hong Kong Serial entrepreneur Dr. Gina Jiang built a number of successful medtech startups in Silicon Valley before joining the Hong Kong Institute of Biotechnology (HKIB) as its managing director. She discusses the institute’s work with vaccines and biologics as well as Traditional Chinese Medicine (TCM), and explains the Advanced Therapy Products…

Switzerland At this year’s Swiss Biotech Day, the Swiss Biotech Association celebrated its 25 years of existence and proved the ability of the sector to weather geopolitical disruptions and funding challenges with the findings published in the Swiss Biotech Report 2023. The organisation also celebrated recent industry successes with its Swiss…

Hong Kong Tech entrepreneur and investor Duncan Chiu has long been committed to developing local technology and innovation in Hong Kong. He discusses the current blueprint for advancing life sciences, advanced manufacturing, AI, big data and FinTech in the region and the need for government involvement to incentivise investment.   Historically, we…