The European Medicines Agency (EMA) protects patients to ensure they are safe. The EMA accesses, supervises and monitor medicines before they can appear in hospitals and pharmacies. The agency monitors information on side effects reports from doctors, pharmacists, patients, new clinical studies and new scientific publications. This data will be reviewed by
The EudraVigilance database is used for the Europe-wide registration and analysis of adverse reactions to medicinal products authorized within the EU. EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA).
In March 2017, it was a historical month, not just for pharmaceutical industry but for the United States of America and the European Union. The amended mutual recognition agreement (MRA) on “Pharmaceutical Good Manufacturing Practices” between the EU and the US was signed. The best outcome is that it could significantly reduce
EU member-states have been urged to do more to safeguard the supply of medicines post-Brexit by European pharmaceutical leaders. The European Federation of Pharmaceutical Industries and Associations called on European leaders to allow medicines and medical devices quality which is tested in the United Kingdom, to be recognised in the European Union.
When medicinal products are imported into the EU, they must undergo batch testing within the European Economic Area (EEA). Once the United Kingdom leave the EU due to Brexit, it has the following effects on the Pharmaceutical industry. Pharmaceutical manufacturers who have previously carried out batch testing in the UK must relocate
IQVIA, the US firm that provides support services in the pharmaceutical, biotech and medical sectors have announced 100 new jobs in Dublin. They have begun recruiting in areas of clinical project management, data management and biostatistics. IQVIA stated how they are seeking pharmacovigilance specialists also. The company expect the jobs to be
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) have released further guidance on how a no-Brexit deal will effect clinical trials, namely: The regulation of medicines The regulation of medical devices The regulation of clinical trials The scenario of a so called “Hard Brexit” is still a possibility and people need
In March 2017, the UK notified the European Council of its intention to withdraw from the EU. Since announcing its intention to leave, the UK has entered talks with the EU to determine the terms of their new relationship. At MIAS Pharma, we have seen a significant increase in requests from clients