According to an executive from the drug development services company, pharma professionals should pay close attention to supply chain continuity and safety in the coming year.
US authorities are holding more excipient imports at ports according to industry group IPEC Americas, which said that the increase has already halted the production of at least one drug.
The MHRA says it will assess the quality of active pharmaceutical ingredients (APIs) imported from outside the EU at manufacturers’ facilities rather than at UK borders.
US officials' new take on import rules may mean APIs destined for trials will only be allowed into the country if they are listed in an effective IND application, according to Clinipace QA chief Nikolas Burlew.
The UN International Narcotics Control Board (INCB) says the diversion of pharmaceuticals at the national level has become one of the major sources of narcotics around the world.
India’s CDSCO has issued draft guidance designed to help active pharmaceutical ingredient (API) importers streamline the submission and registration process.
The US Food and Drug Administration (FDA) has issued a draft guidance on the measures pharmaceutical and other manufacturers should take to make sure imported FDA-regulated products are in line with federal statutes and regulations.
