White House directive aimed at reducing dependence on foreign manufacturers for essential medicines and a seemingly more aggressive stance towards site inspections could signal a worrying emerging trend for India pharma. But it also needs to be viewed through the prism of the upcoming US elections and trade tensions with China amid the pandemic.
US President Donald Trump’s executive order aimed at bolstering domestic production of essential medicines, medical countermeasures, and critical inputs has escalated uncertainty for Indian drug firms, already coping with a challenging business environment, like the rest of industry, amid the pandemic.
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The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
