Tagged with Saudi

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…

Saudi Arabia Saudi Chemical Company Holding (SCCH), Saudi Arabia’s leading manufacturer of civil and military explosives, has been expanding its pharma sector footprint in recent years. Today, the company has capabilities across pharma distribution through SITCO Pharma, manufacturing (both for its own products and as a contract manufacturing organisation (CMO)) via AJA…

MEA Seasoned executive Mohamed Nasser currently oversees 16 markets for Amgen across the MEA region, including its most important – Saudi Arabia. He shares some of the key skills that pharma executives overseeing his region need to succeed.   As region head for a company that is only 40 years old,…

Saudi Arabia While Saudi Arabia is becoming an increasingly attractive investment destination for global pharma, some stakeholders continue to have concerns about whether the country’s intellectual property (IP) protection system is truly fit for purpose.   Oscar Delgado of BMS is one such stakeholder. “An adequate IP system, including regulatory data protection…

Saudi Arabia Before Crown Prince Mohammed bin Salman assumed office in 2017, Saudi Arabian women had only a marginal presence in the Kingdom’s labour force. However, since then notable milestones achieved include granting women the right to drive, access to sports, a first female ambassador, freedom to travel, the right to live…

Saudi Arabia The Saudi medtech market was valued at USD 2.25 billion in 2017 and is expected to reach USD 3.87 billion at a CAGR of 9.5 percent by 2023, according to Market Research Future. Like other parts of the Saudi healthcare continuum, the country’s medtech industry is extremely dynamic and changing…