Tagged with EG

USA The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) approved no less than 55 new drugs in 2023, a number surpassing that of 2022 by almost 50 percent. While 28 rare disease treatments and five novel gene therapies got the green light, the agency also…

Portugal Pfizer holds a prominent position in Portugal’s pharmaceutical landscape, especially in the hospital business and for COVID-19-related products, with the emphasis now on sustainable growth post-COVID. Paulo Teixeira, a 26-year pharma industry veteran, lays out his strategy for the affiliate and highlights some of the key challenges in Portugal’s healthcare…

Pharma Legal Handbook All about regulation, pricing and reimbursement in Indian pharma. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 119.   1. What are the regulatory authorities with jurisdiction over…

Legal Handbook Preclinical and clinical trial requirements in India. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 119.   1. Are clinical trials required to be conducted locally as a condition…

Pharma Legal Handbook An essential legal guide to marketing, manufacturing, packaging & labelling and advertising in Indian pharma. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 119.   1. What is the authorization…

Pharma Legal Handbook A guide to the legal requirements for traditional medicines and OTC products in India. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 19.   1. What are the regulatory requirements…

Pharma Legal Handbook An insight into product liability in India. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 119.   1. What types of liability are recognized in your jurisdiction? Manufacturers, distributors and…

Pharma Legal Handbook Vital info on patents and trademarks in Indian pharma. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 119.   1. What are the basic requirements to obtain patent and trademark…

Pharma Legal Handbook Upcoming regulatory reforms affecting Indian pharma. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 119.   1.     Are there proposals for reform or significant change to the healthcare system? E-pharmacy…

Pharma Legal Handbook Cannabinoid drugs, medicinal cannabis & opioid drugs in India – a comprehensive legal overview. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 119.   CANNABINOID DRUGS Global Comment:…

Pharma Legal Handbook Want to know more about orphan drugs & rare diseases in India? Read on! Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 119.   1. What is the…

Pharma Legal Handbook The key facts about the localization in Indian Pharma. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 119.   1. Are there any rules or regulations requiring and/or…