The number of drug shortages in the US has risen sharply and the FDA has noted a link to manufacturing shutdowns caused by safety and quality concerns. We explore the tightening regulations on generic pharma manufacturing in the US, and also investigate whether the EU’s proposed quality laws for imported APIs could hamper the industry’s ability to produce medicines in adequate quantities.
Novartis, GSK and Emergent BioSolutions are partnering with the US Government to create centres for the development and manufacturing of vaccines and medication in the event of a biological threat. Focusing on the development of new ingredients and manufacturing processes, we find out how the centres will approach the challenge of having to lead the way in America’s biomedical sector in the decades ahead.
We also explore the new markets of outsourced manufacturing which are emerging out of the shadow of the currently dominating giants India and China, and find out how countries like South Korea, Mexico, the Ukraine, Israel and Taiwan are making a name for themselves in the sector.
In this issue
The establishment of three new medical centres for bio-threat countermeasures alongside GSK, Emergent Biosolutions and Novartis could signal a more practical approach to active bio-defence in the US. Focusing on the development of new ingredients and manufacturing processes, we find out how the centres will approach the challenge of having to lead the way in America’s biomedical sector in the decades ahead.
The Drug Crisis
Drug shortages in the US have jumped from 56 in 2006 to 250 in 2011 and the Food and Drug Administration has noted that the majority of these shortages have been linked to manufacturing shutdowns caused by safety and quality fears. We ask how drug shortages can be prevented in the future.
Drug Crisis: The FDA Responds
In response to our investigation, the FDA explains its views on managing drug shortages.
Quality vs. Output
As the EU prepares to introduce new quality laws for active pharmaceutical ingredients imported from outside Europe, drug companies are warning that the regulations could hamper the industry’s ability to produce medicine in adequate quantities. We look at the fierce debate surrounding this legislation and its implication on a globalised drug manufacturing system.
New World Order
While emerging countries like India and China are currently dominating pharmaceutical raw material manufacturing, several other countries are gaining ground. We find out what countries like South Korea, Mexico, the Ukraine, Israel and Taiwan can offer, economically and in terms of safety and quality.
Small Impact, Big Reward
Climate change has a huge effect on pharmaceutical manufacturing, but there are also opportunities for the industry to reduce its reliance on fossil fuels. Nigel Lenegan, director of Energy & Carbon Reduction Solutions, finds out whether climate change is a challenge or opportunity for the pharmaceutical manufacturing industry.
Next Issue Preview
While the US has adopted the FDA Safety and Innovation Act to battle counterfeit drugs, the EU has rejected the controversial Anti- Counterfeiting Trade Agreement. In the next issue we discuss the different regulatory approaches and ask what steps are being taken to protect patients and safeguard profits.
We also profile the most promising innovations in packaging to protect pharmaceuticals, such as 2D codes, RFID, DNA authentication and sophisticated tracking software, as well as looking beyond packaging to find out what other measures the industry can take to tackle the counterfeit problem.
Moreover, we find out what role sustainability plays in pharmaceutical packaging, and how the industry can strike a balance between security and eco credits.
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