Australian Regulator Warns Of Delays To GMP Clearance Processes
Drug sponsors have been told to continue applying for extensions to good manufacturing practice clearances for overseas manufacturing sites as long as they meet the criteria for extension and apply in good time.
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The head of the European Medicines Agency says a group of international regulators got together to ensure “global alignment” on the approach to be taken on COVID-19 vaccination.
Dissent In Parliament As Commission Claims EU Pharma Revision Will Improve Competitiveness and Access
Proposals on regulatory data protection and transferable exclusivity vouchers to encourage antimicrobial R&D have received mixed reactions from the parliament’s rapporteurs for the draft legislation.
A new database being set up in Switzerland is expected to improve the exchange of GMP and GDP information between the regulatory authorities and pharmaceutical companies and offer free access to electronic certificates.