Tagged with regulation,

Regulation Dominique Martin, CEO of the ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) provides a fascinating insight into the French process of authorizing drugs and medical products, his commitment to increased transparency and increased efficiency, and the opportunity for France to take the lead in European…

Algeria With non WTO members such as Algeria flouting intellectual property (IP) it raises the issue of how best to protect and price medicines in the future. In a fascinating interview we spoke to Rachid Kerrar from the Algerian firm Beker about their development of a cheaper, generic version of Gilead’s…

regulation Chinese ecommerce behemoths Alibaba and JD.com are being used to buy and sell tens of thousands of prescription medicines, skirting regulations in what is a legal grey area. According to a recent Financial Times report, dozens of listings from third party vendors – mainly pharmacies – for drugs such as…

Cannabis Following the death penalty handed to Muhammad Lukman, a 29-year old man who was convicted of possessing, processing and distributing medicinal cannabis oil, public outcry has caused Malaysian officials to reconsider the punishment.   Muhammad Lukman was arrested in 2015 for possessing 3.1 litres of cannabis oil, 279 g of compressed cannabis and 1.4 kg of…

regulation The stakes are high, and the outcome is uncertain in one of the largest Pharma M&A deals ever. Takeda’s proposed acquisition of Shire seems to have it all: The combined entity becoming one of the largest global Pharma groups, enabling Takeda to become a truly global operation and allowing Shire’s…

Regulation In this exclusive interview, Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), defines ‘fair pricing’, gives the IFPMA’s take on so-called “cost-plus” pricing models, and talks about access to medicine in developing markets.   The innovative pharmaceutical industry seems to be under unprecedented pressure…

Cannabis In a move to capitalize on a global market projected to exceed USD 60 billion by 2024, Cyprus has joined a growing number of European nations in legally permitting the cultivation and provision of medical cannabis.   The Republic will grant two 15-year licenses to private medical cannabis cultivators to…

Regulation Article contributed by Carla Smith, Executive Vice President of The Healthcare Information and Management Systems Society (HIMMS) for PharmaBoardroom. Today more Canadians are dying in this crisis than at the height of the HIV epidemic. Recognizing that we need to join forces to fight the opioid epidemics in both our nations, Canadians…

Switzerland The past 5 decades have seen monumental strides in healthcare; from the discovery that aspirin prevents blood clotting to the eradication of smallpox. In this exclusive interview, Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) reflects on 50 years of innovation from the associations housed under…

Regulation It has been reported that in 2017 around 72,000 Americans died from drug overdoses, many from opiates. The company receiving the most attention is Purdue Pharma, run by the Sackler Family. Last week, the Financial Times launched multiple reports on the Sackler family and revealed a shocking story of manipulative sales tactics.  The…

Spain María Ángeles Figuerola, director of SEVeM – the Spanish Medicines Verification System – introduces the mission and mandate of the institute, major challenges, and SEVeM’s role within Spain’s healthcare ecosystem. Please start by introducing the mission and the mandate of the institute. “While we may not yet be feeling the effects…

India In a context where even well-established, multi-billion-dollar domestic companies have received warning letters from the US FDA, quality compliance has clearly become strategically important across all layers of Indian organizations, including formulation and API companies as well as both B2B and B2C players.   My approach is extremely simple: quality…