2021 has been a very active year as far as Data Privacy and Life Sciences regulation are concerned:

• 1st January 2021: UK quits the EU, the Brexit is implemented. A 6 months adaptation period follows. A UK Data Protection Representative is mandatory for all organisations with no office in the UK, and selling goods and services in the UK, or monitoring the behavior of people in the UK. Exporters of Medical devices to the UK will have to appoint a UK Responsible Person (UKRP).

• 21 April 2021 - The European Medicines Agency Management Board announced that the audit of the EU Clinical Trials Information System CTIS was satisfactory and the portal will go live on 31 January 2022!. Subsequently, the new EU Clinical Trial Regulation will enter into force on 1st February 2022.

• 26 May 2021: the new EU Regulation for Medical Devices 2017/745 comes into force in the EU.

• 4 June 2021: the European Commission publishes New Standard Contractual Clauses, which are modular, thus easier to use; the situation <hen the Data Exporter is a Processor is covered for the first time. Subsequently, only the 'old' SCCs can be used when personal data are exported from the UK.

• 28 June 2021: UK is deemed as an adequate country by the European Commission; as a consequence, personal data can still be exported from the EU to the UK without a special waiver to be used.

• 17 October 2021, the International Council for Harmonization (ICH) adopted the new release of ICH guideline E8 (R1) on general considerations for clinical studies. It will come into effect on 14 April 2022.



• 1st November 2021: China's GDPR comes into force.

On 17 December 2021, the European Commission adopted an adequacy decision for the transfer of personal data from the European Union to the Republic of Korea under the General Data Protection Regulation.

Personal data will be able to travel safely from the EU to the Republic of Korea to the benefit of citizens and economies on both sides, without any need for further authorisations or additional tools.

Read the press release here.

Questions & Answers page from the European Commission on this adequacy decision: read here.