Tagged with R

Saudi Arabia Last year, Dimitri Livadas made the unconventional leap from Big Pharma to a local Saudi firm, Saudi Chemical. In conversation, he explains the motivating factors behind this decision, including Saudi Arabia’s vision for the future, the legacy and growth potential of Saudi Chemical, and the unique opportunity to be part…

Saudi Arabia With over 40 years of history in Saudi Arabia, in 2021 Eli Lilly moved to establish a regional headquarters in the country, underscoring its dedication to the country and region. Now led by Brazilian national Felipe Borges dos Reis, Lilly aims to tackle the pressing health concerns of diabetes and…

Saudi Arabia Mohamed Abu Shawish of Japanese rare disease specialist Kyowa Kirin outlines how, by focusing on initiatives like genetic testing programs and facilitating treatment delivery to remote areas, the company ensures that rare disease patients in Saudi Arabia receive timely diagnoses and access to essential treatments. He also explains how the…

Saudi Arabia Farrukh Rehan outlines how GSK Saudi Arabia is actively collaborating with the Saudi government to align its initiatives with Vision 2030 and support national healthcare goals. Through strategic partnerships and MoUs, the company ensures the seamless integration of its innovations into the healthcare system, contributing to improved patient access and…

Saudi Arabia Trad Alkhelaiwi lays out the scale of Johnson & Johnson’s transformation in Saudi Arabia, particularly the transition to a direct model in the medtech space, reflecting the company’s long-term commitment to the country’s healthcare sector. Alkhelaiwi also explains how Johnson & Johnson’s solutions in Saudi Arabia are tailored to address…

Saudi Arabia Lifera was established in 2023 to address key priorities outlined in the National Biotech Strategy of Saudi Arabia, focusing on improving biopharma resilience and enabling the development of biologics, vaccines, cell and gene therapies, and other advanced medical therapeutics. The organisation’s first chairman, Ibrahim Aljuffali, explains how Lifera aims to…

Saudi Arabia Karim Smaira and Kamel Ghammachi, founders of Genpharm, underscores the strategic significance of the recent majority acquisition by Abdul Latif Jameel Health, part of Abdul Latif Jameel, driven by a shared vision and the imperative for accelerated growth. They discuss their expansion into diverse therapeutic areas, emphasizing the importance of…

Saudi Arabia aljeel, a leading Saudi family-owned medtech distributor, has undergone a structural transformation in recent years and today attempts to maintain the dynamism of a family business while incorporating the structured processes of a publicly traded entity. Now CEO of the firm, AbdulGhani El-Ajou touches on some of aljeel’s key initiatives,…

Pharma Legal Handbook  1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Ministry of Health and Care Services (Helse- og Omsorgsdepartementet, “HOD”) is the superior administrative authority in Norway, with jurisdiction over drugs, biologicals, and medical devices.   The Norwegian Medical Products Agency (Direktoratet…

Pharma Legal Handbook 16. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Clinical trials are not required to be conducted in Norway as a condition for obtaining a marketing approval. As part of the application for a marketing approval, the applicant must submit clinical…

Pharma Legal Handbook 22. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the counter medications and other medicinal products? See answer to Chapter 1, question 3.   23. What is the authorization process for the marketing of generic versions of these products? To obtain a marketing…

Pharma Legal Handbook 44. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional medicine: The main legal framework regarding traditional medicinal products, regardless of whether the product is a prescription-only or non-prescription (OTC) product, is set out in the Medicines Act (LOV-1992-12-04-132) and the Medicines Regulation (FOR-2009-12-18-1839).…