Some regulatory activities have been on hold at the European Medicines Agency as it prepares for the impact of the UK’s departure from the EU. The EMA is also concerned that unexpectedly high staff losses will seriously affect its ability to operate.
The European Medicines Agency has suspended a number of regulatory activities, including development of the new medicines web portal and work on the e-submission project, and is cutting back on meetings and conferences, to allow it to focus on addressing the implications of its forced relocation out of the UK.
The agency has also issued a stark warning that if levels of job losses resulting from its Brexit-related move to...
The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.
The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.
The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.
European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.
The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.
The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.
Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.
