UK Marketing Authorisation Holders (MAH) should be reviewing their manufacturing processes to identify and diminish any risk of the presence of nitrosamine impurities in their medicines. Read more “Did you know the MHRA have published a new guidance on submission of nitrosamine risk evaluations?”
Year: 2019
A 4-year overview of pharmacovigilance activities in the EU
A report carried out by the European Medicines Agency (EMA) in collaboration with national competent authorities of European Union (EU) Member States, has shown that the EU pharmacovigilance (PV) system is robust and effective at ensuring the safety of medicines. Read more “A 4-year overview of pharmacovigilance activities in the EU”
International regulators launch sterile medicines inspection pilot
A two-year pilot programme for international collaboration in good manufacturing practice (GMP) inspections of manufacturers of sterile medicines has been announced. Read more “International regulators launch sterile medicines inspection pilot”
Highlights from the December CHMP meeting 2019
From their meeting in December, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the December CHMP meeting 2019”
Find out about the eCopy Program for medical device submissions to the FDA
Did you know that section 745A (b) of the Federal Food, Drug, and Cosmetic (FD&C) Act requires submission of electronic copies (eCopy) for medical device submissions? Read more “Find out about the eCopy Program for medical device submissions to the FDA”
Brexit situation following the UK general election result
The Conservative Party led by prime minister Johnson won yesterday’s UK’s general election with a large majority of 76 seats. Read more “Brexit situation following the UK general election result”
The projected changes to pharmacovigilance in the next decade
A recent article published by the European Medicines Agency (EMA) in “Clinical Pharmacology and Therapeutics”, predicts the outlook for pharmacovigilance (PV) in 2030. Read more “The projected changes to pharmacovigilance in the next decade”
A report on the experience of monitoring medicines under the EU Black Triangle scheme
The European Commission (EC) had published a report for the European Council, on the European Medicines Agency’s (EMA) and Member States’ (MS) experiences of monitoring the safety of medicines that are subject to additional monitoring. Read more “A report on the experience of monitoring medicines under the EU Black Triangle scheme”
Highlights from the most recent ICH convergence in Singapore
At the International Council for Harmonisation’s (ICH) meeting in Singapore, the status of activity of the ICH’s Working Groups was reviewed, including several important updates on implementation and communication. Read more “Highlights from the most recent ICH convergence in Singapore”
What is the benefit of the FDA’s new app for reporting novel uses of infectious disease drugs?
The United States (US) Food and Drug Administration (FDA) have launched an application (app) for global health-care professionals (HCPs) to report novel uses of existing medicine for patients with rare and difficult-to-treat infectious diseases. Read more “What is the benefit of the FDA’s new app for reporting novel uses of infectious disease drugs?”