Some important regulatory dates in the calendar

Last updated: 18 June 2022

Some Important dates in the calendar, from a regulatory perspective, are provided in the tables below. This post will be updated on an ad hoc basis.

On mobile, the tables are best viewed by scrolling sideways.

Pharmaceuticals

Region/CountryApplicability date/DeadlineTopicSummary
European Union + Iceland, Norway and Liechtenstein = European Economic Area (EEA)
31 January 2023As of that date all applications for new trials in the EU must go directly through the Clinical Trials Information System (CTIS).
By 26 Sep 2022Nitrosamines:
Step 2 – confirmatory testing of the finished product for
approved products

Step 3 Changes to the marketing authorisation i.e. the submission of any necessary variations


For product containing chemically synthesised APIs, confirmatory testing activities at Step 2 and submission of any changes required to Marketing Authorisations (Step 3), are expected to be finaliied at the latest by 26th September 2022.

Further information available here.
By 1 July 2023 Nitrosamines:
Step 2 – confirmatory testing of the finished product for
approved products

Step3 – Changes to the marketing authorisation i.e. the submission of any necessary variations
For product containing biological APIs, confirmatory testing activities at Step 2 and submission of any changes required to Marketing Authorisations (Step 3), are expected to be finalized at the latest by 1st July 2023.

Further information available here.
Oceania
Australia1 June 2022Transition to eCTD only (Stage 2)The TGA, Australia, has begun begin a staged transition in Q4 2021 to Electronic Common Technical Document-only (eCTD-only) for all prescription medicines.
This transition will see Australia adopt best practice standards that are currently applied across the world.
 The use of eCTD will enhance lifecycle management and navigation ability, making this an effective solution for the compilation, tracking and evaluation of dossiers. and should benefit both sponsors and regulators.

Stage 2 of the TGA transition to eCTD concerns the following application types:

-Extension of Indications Medicine (Type C)
-Major Variation Medicine (Type F)
-New Generic Product (Type D)

Further information is available in this post.
1 July 20222021 Therapeutic Goods Advertising Code This Code came into effect on 1 January 2022. The period for advertisers to transition their material to the new amended rules will be 6 months where both the 2018 and 2021 Codes will apply.
On 1 July 2022, advertisers are required to comply with the 2021 Code.
Further information is available here.
Australia1 Nov 2022Transition to eCTD only (stage 3) Stage 3 of the TGA transition to eCTD concerns the following application types:

-All remaining prescription medicine data including master files

Further information is available in this post.
Australia1 July 2023A new standard for the serialisation of medicines The TGA, Australia has introduced a new standard for the serialisation of medicines and use of data matrix codes, effective from 2023.
Further information available in this post.

Medical Devices

Region/countryDateTopicSummary
Rest of Europe
SwitzerlandBy 31 July 2022Swiss authorised representative (CH-REP) for medical devices Manufacturers based in an EU or EEA state or having an authorised a person based in an EU or EEA state, must appoint a Swiss authorised representative for all products that are placed on the market after May 26, 2021 for:

-Class I products

Further information is available in this post.
UK30 June 2023Medical Devices1) CE marking will continue to be recognised in Great Britain until 30 June 2023

2) Certificates issued by EU-recognised Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023
UK1 July 2023Medical DevicesCurrently, manufacturers of medical devices can use either the UKCA marking or the CE marking on devices they place on the GB market until 30 June 2023.
From 1 July 2023, a UKCA marking will be required in order to place a device on the Great Britain market.
European Union + Iceland, Norway and Liechtenstein = European Economic Area (EEA)
26 May 2022
In Vitro Diagnostic Medical Devices Regulation (IVDR)
The IVDR came into force on 26 May 2017, with a 5 year transition period and will become applicable on 26 May 2022.

In December 2021, the European Parliament and Council adopted an amendment to the IVDR, which defers the dates of application for certain in vitro diagnostic medical devices (IVDs). 
This amendment allows for a more progressive roll-out of requirements and aims to prevent potential disruption to supply of essential IVDs, due to the shortage in notified body capacity
More information is available here.
1 May 2025In Vitro Diagnostic Medical Devices Regulation (IVDR)For higher risk devices, such as HIV or hepatitis tests (class D), the IVDR will apply as from May 2025.
1 May 2026In Vitro Diagnostic Medical Devices Regulation (IVDR) For devices of the lower risk class C, such as certain influenza tests, the date of application of the IVDR is extended until May 2026
1 May 2027In Vitro Diagnostic Medical Devices Regulation (IVDR) For lower risk class devices (class B and A sterile), the application of the IVDR starts in May 2027.