Module 1 2021

25/06/2021

• National Procedures ─ The greatest challenge will come with products registered via the National Procedures ─ These are generally mature products that rely on a minimal investment to maintain on the market ─ In the past, this has often meant only converting content to the CTD when absolutely necessary, let alone the eCTD ─ The eCTD submission format has been mandatory for new national Marketing Authorisation Applications since 01 July 2018. From 01 January 2019 this format also became mandatory for all other submission types. Electronic submissions: Region by region – EU (4)

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Electronic submissions: Region by region – EU (5)

• Means of submission for MRP and DCP ─ The CESP portal is acceptable as a submission route in 26 EU countries and has been a success in providing a simple way to submit electronically to EU NCAs ─ Some countries still have other requirements but the message is generally that electronic working is the way to go • Other submissions ─ The new CT regulation is likely to make an eCTA specification much more of a reality • However, assume that it will use standards for documents already in the eCTD ─ Many NCAs are looking at other submission processes and starting to introduce electronic requirements (PSURs, Scientific Advice, etc.)

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