Tagged with B

Spain A roundup of some of the top stories coming out of Spain’s life sciences sector, including Brookfield’s ongoing interest in Grifols; Rovi’s change of heart about selling its CDMO business; Reig Jofre’s partnership with startup DyCare for an AI-powered digital rehabilitation platform; Almirall’s European filing for its triazole antifungal compound;…

Global In conversation at Clinical Trials on Alzheimer’s Disease (CTAD) 2024 in Madrid, Roche Diagnostics’ Margherita Carboni discusses the potential of blood-based biomarkers to transform Alzheimer’s diagnostics, offering a faster and less invasive alternative to traditional methods. She highlights Roche’s commitment to ensuring diversity in clinical trials, a crucial step in…

Global The 2024 Access to Medicine Index, released today, highlights some of the key milestones reached by global pharma in fostering access to their medicines in low- and middle-income countries (LMICs). Novartis tops the ranking – based on a wide-ranging assessment of access governance, R&D, and product delivery – meaning that…

Pharma Legal Handbook What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The pharmaceutical regulatory body in Egypt is the Egyptian Drug Authority (EDA) operating and working under supervision of the Ministry of Health (MOH) in Egypt. The EDA comprises three independent organizations consisting of the…

Pharma Legal Handbook Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Yes, as there is an Authority “Central Directorate for Research and Health Development”, which is responsible for the registration and approvals of conducting such preclinical and clinical trials.   How are clinical trials…

Pharma Legal Handbook What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The authorization process of marketing new drugs and any medicinal products are as follows: An application for obtaining a marketing authorization for pharmaceuticals is submitted to CAPA. The Pharmacy Law…

Pharma Legal Handbook What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The regulatory requirements for traditional and herbal products shall follow the regulations and standards: – WHO requirements and guidelines; – Good Manufacturing Practices; – Good Laboratory Practice; – Good Pharmacovigilance Practice; – Good Agricultural and Collection…

Pharma Legal Handbook What types of liability are recognized in your jurisdiction? There are two types of liabilities in Egypt, Criminal Liability, in case the product caused any injury, permanent disability injury or wrongful death due to negligence or mistake occurred in the preparation process of the medicinal product. Civil liability, in case…

Pharma Legal Handbook What are the basic requirements to obtain patent and trademark protection? In accordance to the Executive Regulations provided in the Decree No. 1366 of the year 2003, the requirements to obtain patents are as follows: Fill the application for patents at the Patent office; the patent application shall be accompanied…

Pharma Legal Handbook Are there proposals for reform or significant change to the healthcare system? No, but the Comprehensive Health Insurance Scheme Law No. 2 of year 2018 and its Executive Regulations issued by virtue of the Prime Minister’s Decree No. 909 of the year 2018.   When are they likely to come…

Pharma Legal Handbook Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? No, Cannabinoid Drugs are not authorized in Egypt, however, they are regulated by Law No. 182 of the year 1960 concerning combating drugs and regulating their use and trafficking.   2. What are the regulatory authorities with jurisdiction over Cannabinoid…

Pharma Legal Handbook Are biosimilar medicines considered the same as generic medicines in your country? In Egypt, Biosimilars are considered different from Generic Medicines but similar to biological products, where the “Biosimilar” definition according to the Guidelines for Registration of biosimilar products in Egypt, is the following: A similar biological medicinal product having…