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Pharma Legal Handbook 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products? Please refer to Chapter 1, Question 3.   2. What is the authorization process for the marketing of generic versions of these products? Please refer to Chapter 1, Question…

Asia-Pacific Glen Godresse brings over 25 years of pharmaceutical industry experience to his role as Chief Marketing Officer & Head of Commercial Excellence for Menarini’s Asia-Pacific operations. In an exclusive conversation with PharmaBoardroom, he explains how Menarini Asia-Pacific is breaking the mould by focusing on niche therapeutic areas often disregarded by…

Hong Kong Since first allowing pre-revenue biotechs to list in 2018, the Hong Kong stock exchange has welcomed 59 such companies and is now a leading vehicle for allowing Chinese biopharma to access international capital. Christina Bao, HKEX’s co-head of sales and marketing, discusses listing momentum picking up again after a rocky…

Hong Kong Bio-Gene, part of the Pangenia Group, is one of Hong Kong’s most notable life science success stories, with operations in the laboratory supply of instruments, reagents and consumables. Desmond Hau, PhD, who founded the company back in 1993, outlines its growth trajectory, how the Hong Kong innovation ecosystem is evolving,…

China Writing in the August edition of DIA’s Global Forum magazine, Wen Yin of the Pfizer China R&D Center and Wanhe Deng of GSK China Investment look back on four years of China’s marketing authorization holder (MAH)-based regulatory system, including the opportunities it presents, and some of the implementation challenges.  …

Pharma Legal Handbook A brief overview of the situation regarding marketing, manufacturing, packaging & labeling and advertising within Chinese pharma. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for GBP 119.  …

Pharma Legal Handbook All about marketing, manufacturing, packaging & labeling, advertising in Polish Pharma. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119.   1. What is the authorization process for the marketing…

Pharma Legal Handbook The ins and outs of the marketing, manufacturing, packaging & labeling, and advertising in Canadian pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119.   1. What is the authorization process for…

Pharma Legal Handbook A structured legal guide to marketing, manufacturing, packaging & labelling and advertising in Colombian pharma. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 119.   1. What is the authorization process for…

Pharma Legal Handbook Marketing, manufacturing, packaging & labeling, advertising in Romanian Pharma – a comprehensive legal overview. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119.   1. What is the authorization process for the…

Pharma Legal Handbook The key info on marketing, manufacturing, packaging & labelling and advertising pharmaceuticals in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.   1. What is the authorization process for the…

Pharma Legal Handbook A brief overview of the situation regarding marketing, manufacturing, packaging & labeling, advertising in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.   1. What is the authorization process for…