Tagged with BIA

UAE Fokion Sinis, Sanofi Vaccines’ General Manager for the Greater Gulf Multi Country Organisation, outlines some of the key impacts that the COVID-19 pandemic has had on the vaccine industry, the five ‘A’s of successful vaccination campaigns, and his ambitions for the future at a moment of great transformation for both…

LatAm The latest from Latin American pharma, including Moderna’s push to build a regional presence and partnership network; Pfizer’s health equity challenges in the region; and Brazil’s local manufacturing of AstraZeneca’s vaccine and approval of three new cannabis-based products.   Moderna partners with Latin American Pharma https://endpts.com/covid-19-roundup-scottish-government-invests-27m-in-valnevas-covid-19-manufacturing-moderna-partners-with-latin-american-pharma/ In a move to…

Spain Bial’s general manager for Spain and global director of its epilepsy franchise, Ana Álvarez, highlights the importance of the country for the organization – representing 25 percent of overall sales –, explains how she is managing the lifecycle of Bial’s CNS and cardiovascular portfolio, the importance of sustainability, and  the…

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…

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…