Tagged with S

Global Less than two months passed between the WHO’s official pandemic declaration and remdesivir’s emergency use authorisation in the United States in May 2020. Today, the intravenous antiviral, sold by Gilead Sciences under the brand name Veklury, has generated over USD 8 billion in sales.   Remdesivir’s success as a treatment…

Global With Biogen’s recent move to sell off its USD 2.3 billion stake in biosimilars firm Samsung Bioepis against the backdrop of lower-than-expected uptake of its controversial Alzheimer’s Disease drug Aduhelm, PharmaBoardroom takes a look at the contrasting fortunes of two key firms operating in the global biosimilars market today.   Global…

Spain Madrid’s Minister of Health, Enrique Ruiz Escudero, explains in detail how the Autonomous Community executed a different COVID-19 strategy from other Spanish regions, following a “basic health zones” model, why it might be too soon to speak about “flu-isation”, and their plan to boost home hospitalisation and telemedicine.   We…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Saudi Food & Drug Authority (SFDA) is the government agency that regulates drugs and medical devices in Saudi Arabia. It is also in charge of biological and chemical substances in Saudi Arabia. …

Pharma Legal Handbook 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? It is mandatory to inform SFDA immediately about any Suspected Unexpected Serious Adverse Reactions (SUSAR) as soon as possible, no later than 15 days. If the SUSAR is fatal or life-threatening, SFDA…

Pharma Legal Handbook 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The MAA of the pharmaceutical product will be subjected to the followings processes:  Submit the application form and pay the fees. Upload the product file; The components of the…

Pharma Legal Handbook 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? This presentation comprised a briefing on the current situation of the practice of traditional medicine (TRM) and complementary and alternative medicine (CAM), the availability of two kinds of herbal products, from local and imported crude…

Pharma Legal Handbook 1. What types of liability are recognized in your jurisdiction? Product liability is the area of law in which manufacturers, distributors, suppliers and retailers are held responsible for any injuries products cause. Generally, there are three liabilities: Civil liability, punitive liability and disciplinary liability recognised in Saudi Arabia.    2.…

Pharma Legal Handbook 1. What are the basic requirements to obtain patent and trademark protection? Trademarks, copyright works, patents, industrial designs and domain names are all capable of being protected in Saudi Arabia and there is an established legal framework that supports the registration and records of these valuable IP rights. Protection can…

Pharma Legal Handbook The key facts about Regulatory Reforms in Saudi Arabia. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: Saudi Arabia, available to purchase here for GBP 99.   1. Are there proposals for reform or significant change to the healthcare system?…

Pharma Legal Handbook Cannabinoid drugs, medicinal cannabis and opioid drugs in Saudi Arabia – a comprehensive legal overview.. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: Saudi Arabia, available to purchase here for GBP 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized…

Global Writing in the February edition of DIA’s Global Forum magazine, Candice Del Rio of Curavit Clinical Research examines the applicability of decentralised clinical trials in oncology research, and their positive impact on both decreasing patient dropout rates and increasing patient engagement. Oncology represents the largest research area globally, with 6.5 percent…