The European Commission (EC) and European Medicines Agency (EMA) will collaborate with China’s National Medical Products Administration (NMPA) to conduct a gap analysis on the Chinese and EU regulatory systems for active pharmaceutical ingredients (API). Read more “Addressing concerns surrounding China’s API manufacturing quality”
Category: Medicinal product
What are the latest recommendations for improving the delivery of Complex Innovative Design cancer trials?
A group of UK experts have made recommendations on the use of Complex Innovative Design (CID) cancer trials. Read more “What are the latest recommendations for improving the delivery of Complex Innovative Design cancer trials?”
Find out more about the hot topic of drug repurposing in regulatory affairs
Following on from an in-depth article in TOPRA’s Regulatory Rapporteur, this news item outlines our company’s additional views on the rationale behind drug repurposing. Read more “Find out more about the hot topic of drug repurposing in regulatory affairs”
Did you know the MHRA have published a new guidance on submission of nitrosamine risk evaluations?
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?”
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”
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”
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?”
Are you aware that the CMDh have released a useful best practice guide on multilingual packaging?
The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) have published a best practice guide for marketing authorisation applicants, covering multilingual packaging requirements for mutual recognition (MR) and decentralised procedure (DCP) products. Read more “Are you aware that the CMDh have released a useful best practice guide on multilingual packaging?”