Tagged with Technology

Saudi Arabia Alcon’s Fadi AlSafadi shares his insights on the evolving eye care landscape in the dynamic Middle East and Africa region. He discusses Alcon’s innovative initiatives, including advancements in digitalisation, sustainability efforts, and their approach to enhancing accessibility and education. AlSafadi also highlights Alcon’s commitment to improving healthcare outcomes, fostering local…

Hong Kong Drawing on an extensive management background in telecom, IT, and digital, Vincent Ma now serves as CEO of the Hong Kong-Shenzhen Innovation and Technology Park (HSITP). He outlines the under-construction tech park’s unique positioning, linking Hong Kong’s jurisdiction with mainland China’s resources, and HSITP’s plans to attract both Chinese and…

Hong Kong One year since our last conversation, the Hong Kong Institute of Biotechnology’s Gina Jiang introduces the significant strides made in setting up a GMP facility for CAR-T cell therapy manufacturing at HKIB. Regulatory frameworks have now been developed to support clinical trials and the rollout of advanced therapies. Jiang highlights…

USA At the American trade association’s latest CEO & Investor Conference, the board chair of the Biotechnology Innovation Organization (BIO) Ted W. Love discussed US policies and speculated about the impact of the upcoming American election on the industry while affirming that biotech continues to thrive in spite of recent challenges.…

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 Currently there are no policies in place in this regard.   b. Clawback/Payback/Discounts/Rebates In Portugal, the main mechanism for cost-containment is the prior evaluation, regulated…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal.  1. Please make a general introduction to the public health sector in your country and its organization The Public sector is composed of the National Health Service (Serviço Nacional de Saúde), also referred as the…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal.  1.Which are the administrations, bodies and institutions in charge of public health in your country and what are their respective responsibilities? The most relevant administrations, bodies and institutions in charge of public health in Portugal…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal.  1. What are the pricing models, processes and principles for originator drugs? Prices of medicinal products are regulated by the System of Assessment of Health Technologies (SiNATS), approved by Decree-Law 97/2015, 1 June 2015, which…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal.  1. Price 1.1. How does price control at ex-factory prices work in your country? Ex-factory prices (PVA) are relevant to determine the retail price (PVP) of medicinal products and their maximum legal margins, as below.…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal.  1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? The CATS and the DATS are responsible for SiNATS.   2. Do regulators require HTA studies in your country?…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal.  1. Have local authorities published recommendations surrounding value assessment dossiers? (If yes please add link) Yes. Infarmed has published methodological guidelines for pharmacotherapeutic and economic assessment. The recommendations can be consulted here.   2. Have…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal.  1. In addition to the clinical data obtained through clinical studies please list the data required for: a. Market approval The data that must be submitted varies according to the type of medicinal product and…