The Medicines and Healthcare products Regulatory Agency (MHRA) has outlined plans for major reforms to streamline the process of testing, developing, and launching drugs for rare diseases in the UK.
Most pharmaceutical manufacturing facilities in the US are situated in regions prone to hurricanes, wildfires, and other natural disasters, placing the supply chain in significant jeopardy, according to a research letter published in JAMA.
A European Parliament committee has proposed changing the draft Critical Medicines Act (CMA) to reflect the impact environmental measures have on drug supply.
Medicine and medical device industry groups have told the EU how they would like the region to respond to tariffs the Trump administration has imposed on imports into the US. The talks took place before 9 April, when US President Donald Trump paused the higher tariffs on the EU for 90 days.
The groups have published a series of position papers on topics such as phasing in ePI, alternative ways of providing printed package leaflets, and removing the name of the manufacturer from package leaflets.
The European Council has adopted rules on the treatment of urban wastewater, advancing legislation that pharma groups have said will have a 'negative impact on patient access” and 'generate a tsunami” of drug shortages.
The Indian Pharmacopoeia Commission (IPC) has released for consultation draft guidance on the use of disinfectants and antiseptics in drug manufacturing facilities. The document is an updated version of the drafts for consultation IPC published in March and July.
HTAR states the JCA report 'should be factual and should not contain any value judgment.” Assessments of the certainty of study results must remain descriptive at the European level and avoid conclusions that may interfere with independent decision-making at the national level.
The World Health Organization (WHO) has finalized its first-ever guidance to limit waste from antibiotic manufacturing facilities in an effort to address antimicrobial resistance (AMR).
The European Commission approved up to 1 billion Euros of state aid for the first Important Project of Common European Interest (IPCEI), known as Med4Cure. The initiative aims to accelerate drug discovery, especially in rare diseases, and develop sustainable pharmaceutical production processes.
