π EU proposes changes to pharma laws; India approves new medical devices policy; Malaysia gets traditional medicine research framework
#328 | PRETing for future pandemics; Getting malaria vaccines to market; Looking at long Covid
Hello, and welcome back to The Kable on this fine Thursday. If you're one of our eagle-eyed readers who noticed the typo in yesterday's edition, thatβs today, not yesterday. But like yesterday, today is also an action-packed day for the life sciences, what with the US FDA chasing more quality lapses, mpox exploring new locations, and the EU picking a fight with the pharmaceutical industry.
The US FDA is doing what the US FDA does. Issuing warning letters and Form 483s. This time, Egyptian manufacturer Pharmaplast is in the line of fire. The company received aΒ warning letter earlier this month over its failure to properly test its ethanolΒ and each of the components used in its production, as well as its inadequate cleaning procedures. Meanwhile, in Iceland, manufacturerΒ Alvotech has received another Form 483Β over quality unit deficiencies in lab data reviews, SOPs not being followed, and insufficient quality assurance.
The FDA has also handed out some thumbs ups though. Seres Therapeuticsβ pill Vowst, made from healthy bacteria found in human poop, got theΒ green light from the FDAΒ as a simpler intervention to combat dangerous gut infections requiring stool-based procedures. Faecal transplants ftw!
Australiaβs mRNA Victoria, South Africaβs Afrigen Biologics, and the South African Medical Research Council have signed an MoU to collaborate onΒ improving access to mRNA technology in LMICsΒ and train workforces in advanced mRNA manufacturing techniques.
Over in Ghana,Β Unichem is setting up a pharmaceutical plant in AccraΒ to produce London United Exports Ltd (LUEX) pharmaceutical products to supply the African region.
In a bid to improve pharma product quality, Egypt wants to increase its partnerships with local as well as foreign companies, with a specific focus on localising tech for antibiotics and chronic disease treatments. The Egyptian government has announced thatΒ deliberations with local and Indian investors are in progressΒ to launch projects worth $80 million for pharmaceutical raw material manufacturing.
Traditional medicine has its sceptics and its believers. What it doesnβt have is any research guidelines. But Malaysiaβs taking care of that too. The countryβs Ministry of Health is launchingΒ the worldβs first traditional and complementary medicine research frameworkΒ with herbal medicine research guidelines, developed with the help of the WHO.
In India, the medical devices industry is looking at steep growth in the next five years.Β The Union Cabinet has approved the National Medical Devices Policy 2023. With the objectives of improving access, affordability, quality and innovation of medical devices in the country, the policy comprises interventions with regard to regulatory streamlining, infrastructure and human resource development, promotion of R&D as well as attracting investments.
And finally, in neighbouring Pakistan, the National Institute of Health has confirmedΒ the countryβs first case of mpox.
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