Marketing authorisation holders should register a central contact point to inform the EMA about the availability of certain critical medicines.
The recently published EMA Annual Report 2021 gives a good overview of the Agency's activities in the first chapter, such as actions related to the management of the COVID 19 pandemic, work related to the scientific evaluation of medicinal products and their monitoring.
A pilot project will be launched under the auspices of ICMRA to conduct hybrid inspections at facilities of applicants.
Once again, the list of reference standards, which includes more than 3,000 substances, has been revised and the resulting changes and innovations have been listed in the Newsroom of the EDQM website.
Before approving an application, the FDA must determine whether the drug product is both safe and effective for use. A new draft guidance describes the FDA principles when conducting product quality-related assessments of CMC information.
The FDA published a new guidance on the readability of container labels and carton labeling design. What is the recommended font size?
The EMA provides guidance for sponsors who have to report SUSARs via EudraVigilance originated in the context of clinical trials. In addition the updated document "Key Information for Sponsors on CTIS" has been published.
Growers and importers of cannabis flowers have reported to the German BfArM that the specification requirements of the DAB monograph Cannabis Flower cannot be met, especially for low cannabinoid contents. The BfArM has now worked out a compromise for cannabis used for magistral preparations.
In the Pharmeuropa Bio & Scientific Notes, a free online journal of the EDQM, a new scientific article entitled "Weighing according to the European Pharmacopoeia: general considerations and new general chapter 2.1.7. Balances for analytical purposes" was published.
The United Kingdom (UK) becomes a full member of three international associations, including the International Council for Harmonisation ICH.