December 17, 2021
IPOPI has been very busy at the European Medicine Agency (EMA)
During the PCWP/HCPWP meeting in September COVID-19 was discussed, with reports on new approved therapies and the number of new applications pending 219 for therapeutics and 66 for vaccines. Pharmacovigilance is leading to an effective risk minimisation of the speedily approved new medication. Discussions about digitalisation and Big Data (important stakeholder event on 7th December) were high on the agenda. What are the benefits to patients and what is the interest to patients? Important questions as patient representatives will be involved in this regime. Information about EMA’s new Mandate, shortage of medicines and medical devices, annual meetings with FDA, Public Health and cross birder healthcare was presented.
Enpr-Ema (European network of paediatric research). There is a lack of paediatric clinical trials and it was felt that maybe Big Data Steering Group – DARWIN, might give access to Real World Data so contributing to medicine development in evolving healthcare systems. There will be a new regulation on a register of clinical trials in the EU on 31st January 2022. From that date a single application for a clinical trial can be made, rather than register this in every EU Member State. The public will have access to some of the information. COVID-19 in children was discussed with vaccinations for the different age groups and different types of vaccines. Therapeutics should be used in children of 12 years and older.
IPOPI is very honoured to be part of the Emergency Task Force (ETF), whose participants meet three times per week to take quick and coordinated regulatory action relating to COVID-19 medicines. Vaccines, boosters and monoclonal antibodies are among the many items discussed.