CTD creates review backlog in UK
applications because of a huge number of files submitted ahead of
new EU legislation.
The UK Medicines and Healthcare products Regulatory Agency has admitted to delays in the processing of marketing applications because of a huge number of files submitted ahead of new European Union legislation.
The Common Technical Document, which came into force on 1 July, is designed to make mutual recognition of marketing application dossiers for medicines easier between regulatory authorities around the world. It includes a standardised format that differs from that formerly in use in the UK.
There was a large influx of Marketing Authorisation Applications (MAAs) during June - more than three times the usual monthly volume - as companies tried to beat the CTD deadline.
The MHRA said it will probably take until Christmas before processing times get back to normal. However, this is providing that a further surge in applications is not received this month by applicants wishing to beat the revised CTD deadline of 31 October.
"If this happens, then processing times may continue to be prolonged until into the New Year," said the agency in a statement.
Meanwhile, there have also been delays in setting procedure start dates for Variations to Marketing Authorisations in the UK. This has resulted from a higher-than-average submission rate in the build-up to the start of new requirements that come into force at the MHRA today.
