Tagged with P

Saudi Arabia Noncommunicable diseases are the leading cause of death and disability worldwide, accounting for 74 percent of all deaths and more than three out of four years lived with a disability. These chronic conditions – which cannot be transmitted from person to person and often require long-term or lifelong care –…

Europe Last year the European Commission (EC) came out with a proposal to reform the EU’s core pharmaceutical legislation, aiming to address affordability, accessibility, and availability, among other objectives. One of the key changes proposed was reducing the EU’s baseline regulatory data protection (RDP) timeline, a plan that pleased the generics…

Europe Vikas Krishan, chief digital business officer at the global data and digital engineering solutions firm Altimetrik, outlines the implications of the European Union’s forthcoming AI Act for the pharma industry and urges for the need to adopt a proactive approach in evaluating AI roadmaps and governance.   The pharmaceutical industry’s…

China A roundup of top stories from China’s pharma industry, including BeiGene’s new US R&D and manufacturing facility; Merck’s purchase of investigational B-cell depletion therapy from Curon Biopharma, and the Chinese approval of AstraZeneca and Daiichi Sankyo’s gastric cancer therapy.   China’s BeiGene opens new clinical R&D and biologics manufacturing facility…

Hong Kong Chuen Yan Leung leads life science-focused venture capital firm Silver Dart Capital based out of Hong Kong and also serves as vice chairman of the Hong Kong Biotechnology Organization. In conversation, Leung outlines Silver Dart’s investments in growth-stage healthcare companies that are already scientifically de-risked and generating revenue; some of…

Hong Kong With its dual business approach – commercializing acquired products while developing a novel respiratory disease pipeline – Nuance Pharma, after closing Series D funding and establishing a solid revenue stream, has set its sights on Asia Pacific. Founder and CEO Mark Lotter, discusses the regulatory and talent acquisition challenges in…

Europe Contributing to the August 2024 edition of DIA’s Global Forum magazine, Magda Chlebus from the EFPIA, Steffen Thirstrup and Alberto Ganan Jimenez from the EMA, Katharina Nothelfer of AiCuris Anti-infective Cures, Pedro Franco of Merck Serono, Annette Bakker of CTF Europe, Tim Chesworth of AstraZeneca, Jeevan Virk of Novartis, Virginie…

Global DIA’s Sorcha McCrohan, contributing to the the August 2024 edition of DIA’s Global Forum magazine, reviews insights from the town hall meetings that brought together regulators from around the world at the organization’s Global Annual Meeting 2024.   Regulators worldwide recently convened in San Diego for DIA’s Global Annual Meeting 2024 to…

Switzerland Switzerland, home to industry giants like Novartis and Roche, boasts a thriving pharma industry that generates some seven percent of the country’s GDP, as well as a flourishing biotech scene. However, all is not so well in Switzerland’s domestic healthcare landscape, where surging insurance premiums and drug costs mean that…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The regulatory authority responsible for drugs, biologicals, and medical devices in Iraq is the Ministry of Health “MoH”. There is a dedicated body within the MoH known as the Iraq Drug Regulatory Authority…

Pharma Legal Handbook 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? In Iraq, it is not always explicitly required that the clinical trials be conducted locally for marketing approval. However, if local data are requested, companies must comply with these requirements. Local clinical…

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? In Iraq, the authorization process for marketing new drugs, biologics, medical devices, over-the-counter “OTC” medications, and other medicinal products is managed by Iraq Drug Regulatory Authority “IDRA” at Ministry…