The US market is dependent upon API and generic drugs produced in India and China, yet these countries also received the majority of warning letters issued by the US FDA.
A joint study conducted by the EMA and FDA showed that marketing approval decisions were 90% shared for new medicines, as the agencies push for a closer working relationship.
The EMA demands drug developers to change the name of medicines containing liposomal, following reports of ‘serious medication errors’, some leading to death.
July has seen a number of actions taken by regulators to manage the supply of medicine, including a crackdown on CBD manufacturers and repackers of opioid medication.
The two regulatory agencies have confirmed the addition of the last country to their mutual recognition agreement, with GMP inspections by Slovakia given a positive assessment.
The EMA looks to the future by posting its five key priorities to address in the coming five years, which includes the need to recruit expertise in ‘novel manufacturing technologies’.
With Germany’s addition to the US FDA-EMA mutual recognition agreement, only Slovakia is left to be added to the agreement, with the deadline later this month.
The EMA’s investigation into ‘sartan’ medicines has concluded, requiring companies to review processing procedures and prove products are without impurities.
Novartis joined industry associations in expressing concerns over the impact that a ‘hard’ or ‘disorderly’ Brexit could have on the life sciences sector.
