Tagged with EG

Egypt The head of the Pharmaceutical Chamber of the Federation of Egyptian Industries, Gamal El-Leithy, shares his view on the positive developments driving the growth of Egypt’s pharma market, including the creation of an independent regulatory body and a procurement agency. In addition, he analyses the country’s response to the COVID-19…

Global Sarah Pope Miksinski, executive director/CMS regulatory affairs, and Gregory Rullo, senior director regulatory affairs, at AstraZeneca discuss the need for common ground among regulators and industry when it comes to patient centricity and for strategic leadership to address differing regulatory control-strategy requirements. In today’s increasingly complex and intricate pharmaceutical landscape,…

Egypt The head of the Egyptian Unified Procurement Authority (UPA), Major General Doctor Bahaa El Din Zeidan, outlines the agency’s view on tenders, emphasizing their vision to secure the highest quality at the best price for Egyptian patients, and analyses the country’s healthcare transformation. In addition, he argues in favour of…

Pharma Legal Handbook 1. Are biosimilar medicines considered the same as generic medicines in your country? No. At present, a “biosimilar” is not the same as a generic drug. Previously, some biological marketing authorization licenses were obtained by using the same registration pathway of generic medicines (i.e., without the submission of pre-clinical or…

Pharma Legal Handbook The key facts about biosimilars and biologics in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here.   1. Are biosimilar medicines considered the same as generic medicines in your country? A…

Pharma Legal Handbook The key facts about localization in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 149.   1. Are there any rules or regulations requiring and/or encouraging localization in your…

Pharma Legal Handbook Keen to learn more about cannabinoid drugs, medicinal cannabis and opioid drugs in Japan? Read on! Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 149.   Cannabinoid Drugs 1. Are…

Pharma Legal Handbook The ins and outs of orphan drugs & rare diseases in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 149.   1. What is the definition of Rare Diseases…

Pharma Legal Handbook The key facts about regulatory reforms in Japanese Pharma. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 149.   1. Are there proposals for reform or significant change to the…

Pharma Legal Handbook The legal framework for patents and trademarks in Japanese Pharma. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 149.   1. What are the basic requirements to obtain patent and…

Pharma Legal Handbook All legal aspects surrounding product liability in Japanese Pharma. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 149.   1. What types of liability are recognized in your jurisdiction? Contract…

Pharma Legal Handbook A brief overview of the situation regarding traditional medicines and OTC products in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 149.   1. What are the regulatory requirements…