ASEAN A roundup of some of the most important recent pharma news from the dynamic ASEAN region, including a big new investment from Novartis in its antibody plant in Singapore, the establishment of ‘pharmaceutical ecozones’ to streamline the drug application process in the Philippines; Vietnam’s journey to attaining WHO Level Four…
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…
Portugal From software development to sales and consultancy, Alexandre Leiria today heads up the Life Sciences, Healthcare, and Manufacturing arm of digital-focused consultancy Capgemini in Portugal. He discusses Capgemini’s role in advancing digital transformation in the Portuguese healthcare sector. Despite progress, challenges remain, such as the need for further investments and…
USA Francesco Lanucara of PharmaLex, writing in the November 2023 edition of the DIA’s Global Forum magazine takes a look at how new guidance from the US FDA aims to tackle the myriad challenges of cell and gene therapy manufacturing comparability and complexity. Development of cell and gene therapy (CGT)…
Global Smart manufacturing has become a key component of today’s industrial evolution and unlocked unprecedented efficiencies and quality enhancements. Smart Manufacturing expert Eric Whitley outlines the specific benefits of smart manufacturing for the pharmaceutical industry, illustrating these benefits with industry case studies. Smart manufacturing has entered the world of modern…
Hong Kong With the global market for cell and gene therapy (CGT) products set to skyrocket in the coming years, Hong Kong is looking to get in on the action with the opening of a new Advanced Therapy Products (ATP) Good Manufacturing Practice (GMP) Centre earlier this month. Leveraging the city’s…
South Africa Roughly half of Africa’s 1.1 billion people lack regular access to even the most essential medicines and most of Sub-Saharan Africa depends on imports which make up as much as 70 to 90 percent of the medicines consumed there. As the COVID-19 pandemic further demonstrated this dependence and the vulnerability…
Greece DEMO, founded in 1965, is a mainstay of Greek pharma and one of its largest companies, accounting for 25 percent of the total investment across the entire Greek pharmaceutical sector. Throughout its long history DEMO has shifted its focus, moved towards exports and weathered Greece’s financial crisis. Today, the family-owned…
Africa Diabetes is a significant, and growing, problem in Africa, making access to insulin products a regional imperative. Some important progress is being made, including a new deal between US giant Eli Lilly and Egyptian group EVA Pharma. The agreement will allow Lilly products to be manufactured in, and for, the…
Greece The European Union’s decision to mitigate the effects of the COVID-19 pandemic by launching its Recovery and Resilience Facility (RRF) and moving away from its past austerity policies is particularly significant for Greece. Severely hit by the financial crisis a decade ago and thrown off its course to recovery by…
Egypt The leading company in the Egyptian pharma market by volume, the Egyptian International Pharmaceutical Industries Company (EIPICO) is now making a region-first move into biologicals and biosimilars manufacturing to power its future growth as well as expanding its international footprint. Biologics: A Big Leap Forward The company’s plan to…
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. …
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