Tagged with HE

Global ISPOR—The Professional Society for Health Economics and Outcomes Research (HEOR), and PharmaBoardroom’s content partner, continues to monitor healthcare trends and conduct horizon scanning around the world. The “ISPOR 2024-2025 Top 10 HEOR Trends” marks the fifth publication of the Society’s biennial report, which is based on input from its members…

UK A roundup of some of the biggest stories coming out of the UK pharma industry, including AstraZeneca’s bid for cancer specialist Fusion Pharmaceuticals; the shutdown of Sanofi’s R&D site in Cambridge; the GBP 17.9 million initiative to boster UK clinical trials, and Obsidian Therapeutics’ USD 160.5 million Series C funding raise.…

India India’s National Chemical Laboratory (NCL), one of the most well-established labs in the wider Council of Scientific and Industrial Research (CSIR) network, has made some major contributions to improving the country’s manufacturing processes for pharmaceutical intermediates and APIs. Director Dr Ashish Lele outlines the approaches the lab is pursuing, such…

Germany The biggest pharma industry and healthcare stories from Germany, including the country’s legalisation of cannabis; the MASH potential of Boehringer Ingelheim’s obesity candidate; Bayer’s further share price drop and expansion into the US; the antibody-drug conjugate (ADC) specialist Tubulis’ series B2 financing, and Novartis’ deal with biotech MorphoSys.   Germany’s…

Opinion Writing in the March 2024 edition of the DIA Global Forum magazine, experts from Moderna, Cencora PharmaLex, CureVac, and BioNTech review the scientific potential and regulatory challenges, such as the lack of global harmonization, surrounding gene therapy-based medicinal products. Gene therapy medicinal products (GTMPs), which in the European Union (EU)…

Switzerland The biggest pharma news from Switzerland, including the industry’s cautious reaction to a new free trade deal with India; the drop in Roche’s share prices; Novartis’ acquisiton of MorphoSys, and the licence agreement between EraCal Therapeutics and Novo Nordisk.   Swiss industry welcomes agreement with India, pharma more cautious (Le…

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 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Ministry of Health, Welfare and Sport (Ministerie van Volksgezondheid, Welzijn en Sport) The policy and regulation of drugs (‘medicinal products’), biologicals and medical devices falls under the jurisdiction of the Ministry of Health,…

Pharma Legal Handbook 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials do not have to be conducted locally as a condition for marketing approval. This is not one of the prerequisite conditions for approval of the clinical trial protocol, which…

Pharma Legal Handbook 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products? Please refer to Chapter 1, Question 3.   2. What is the authorization process for the marketing of generic versions of these products? Please refer to Chapter 1, Question…

Pharma Legal Handbook 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In principle, the regulatory framework set out in the previous Chapters applies. However, differing requirements or procedures apply for specific types of medicinal products. The Medicines Act distinguishes several types of medicinal products, including homeopathic…

Pharma Legal Handbook 1. What types of liability are recognized in your jurisdiction? Dutch liability law generally distinguishes between contractual liability on the one hand and non-contractual liability on the other. Non-contractual liability not only includes fault-based liability (‘onrechtmatige daad‘) but also includes a regime of strict liability for defective products (‘productaansprakelijkheid‘). The…