Tagged with Pharma

Pharma Legal Handbook The key facts about regulatory reforms in Italy. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? In Italy, the…

Australia A roundup of some of the latest news from Australian pharma, including CSL’s unification of business units, a workers strike at Pfizer’s manufacturing plant, a new USD 173 million research centre, and a billionaire’s bet on biotech.   New $173M research centre for pandemic drug discovery (Endpoints News) In the…

Middle East & Africa Samir Khalil, executive director for the Pharmaceutical Research and Manufacturers of America (PhRMA) Middle East and Africa, touts the USD 1.1 trillion that its member companies have invested in R&D since 2000 and analyses the opportunities in Egypt as the country moves closer to implementing universal healthcare. In addition, he…

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…

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…

USA While patient groups view the United States’ new Inflation Reduction Act as a positive move towards capping out-of-pocket drug costs for older Americans, the innovative pharma industry, after aggressively lobbying against it, still argues that the new legislation will hamper drug development. [The new law] is a significant step in…

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…