Tagged with M

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…

MEA In the February edition of DIA’s Global Forum magazine Sybil Nana Ama Ossei-Agyeman-Yeboah of the West African Health Organization, Jane H. Mashingia from the East African Community Medicines Regulatory Harmonization Programme, and the Bill & Melinda Gates Foundation’s David Mukanga examine the state of joint assessment procedures in the East…

USA Pfizer and MSD recently became the latest companies to have COVID-19 treatments authorised by either the US FDA or EMA. Their oral antiviral drugs joined several monoclonal antibodies and others on the list of options available to patients in Europe and the United States. Here is an updated list of…

Spain CataloniaBio & HealthTech is an industry association representing the biomedicine and health sector in Catalonia. Its CEO, Judit Anido, explains how the region’s entrepreneurial spirit is helping it lead Spain in research and innovation, and comments on regulatory changes needed to help small- and medium-sized companies grow into a competitive…

Spain Lilly’s Nabil Daoud highlights the evolution in the firm’s Spanish manufacturing and R&D footprint in recent years, discussed launch plans for its next-generation diabetes and obesity treatments, and outlines some of the key trends currently impacting healthcare in Spain.   Four years ago, a molecule discovered and designed by scientists…

Italy   In a wide-ranging and candid conversation, Amgen Italy General Manager Soren Giese outlines the strategy he put in place to restructure Amgen’s operations in the Italian market, the company’s third largest in Europe and sixth largest globally. Giese also touches on ensuring the affiliate’s product launch readiness, consistently increasing…