New year. New regulations.

Do you know what is happening in regulatory next year? 2022 is coming to an end and we are looking forward towards 2023. Here we list some important regulatory changes:

CTIS
On Jan 31, 2023, The Clinical Trials Information System (CTIS) will become mandatory for submission of Clinical Trials in Europe. Sponsors can use CTIS to apply for authorisation to run a clinical trial in up to 30 EEA countries via a single on-line application.

Variations application form
A second release of the web based Human Variations electronic application form is planned for March 2023 and will support all types of EU variation procedures (both CAPs and NAPs). The release will be followed by a 6-month transition period during which both the PDF eAF and the web-based form can be used in parallel.

DSCSA
In November 2023, the FDA Drug Supply Chain Security Act (DSCSA) comes into effect. The act outlines steps to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States. There are four important requirements to be aware of; product serialisation, product tracing, verification (of product identifiers), authorised trading partners.