From their meeting in June, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the June CHMP meeting 2020”
Category: Medicinal product
Recommendations to help reduce the risk of impurities in medicines
European regulators have proposed 40 recommendations to help reduce the risk of impurities in medicines, and to ensure that regulators are better prepared to manage cases of unexpected impurities. Read more “Recommendations to help reduce the risk of impurities in medicines”
Highlights from the May CHMP meeting 2020
From their meeting in May, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the May CHMP meeting 2020”
EMA checklist for initial notifications for parallel distribution
The European Medicines Agency (EMA) has released guidance for industry with a checklist for use in advance of submission of initial notifications for parallel distribution. Read more “EMA checklist for initial notifications for parallel distribution”
Antiviral treatment breakthrough for COVID-19
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has started a rolling review of the investigational antiviral medicine for the treatment of COVID-19 patients called remdesivir, a viral RNA polymerase inhibitor previously indicated for use against Ebola. Read more “Antiviral treatment breakthrough for COVID-19”
Highlights from the April CHMP meeting 2020
From their meeting in April, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the April CHMP meeting 2020”
The potential impact of COVID-19 on MRP and DCP applications
The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has released a question and answer guidance outlining how regulatory flexibilities will affect these application procedures due to the pandemic. Read more “The potential impact of COVID-19 on MRP and DCP applications”
Regulators issue warnings for use of malaria drugs for COVID-19
Chloroquine and hydroxychloroquine have been touted as potential treatments for COVID-19 patients, however clinical data is still very limited and the beneficial effects of these medicines in COVID-19 have not been demonstrated. Read more “Regulators issue warnings for use of malaria drugs for COVID-19”
Four key features influencing FDA review times of new drug applications (NDA)
According to a Government Accountability Office (GAO) report, the length of review of an NDA by the US Food and Drug Administration (FDA) is reflective of four features of the application. Read more “Four key features influencing FDA review times of new drug applications (NDA)”
Highlights from the March CHMP meeting 2020
From their meeting in March, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the March CHMP meeting 2020”