To ensure the Beijing Winter Olympics is a smooth affair, the Chinese government has ordered partial or complete halts in industrial production in some provinces from late November until mid-March, disrupting an already fragile active ingredient supply chain.
China’s clampdown on polluting industrial units ahead of the Beijing Winter Olympics is raising the prices of active pharmaceutical ingredients (APIs) and key starting materials (KSMs), which along with concerns over the Omicron SARS-CoV-2 variant, could signal a perfect storm building for the pharma industry in the days and months ahead.
China’s moves are expected to disrupt a large part of the nation’s production, partially initially but then moving to a...
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.
