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Top developments and predictions in the Life Sciences & Healthcare sector in Asia-Pacific
APAC region 16.04.2024
In this round-up, we look back at the top developments over the last 12 months in the life sciences & healthcare (LSHC) sector, and we look to the future with our top predictions for the coming year...
Navigating clinical trial disclosures: No reasonable expectation of success in a patient sub-population in view of prior art reporting phase III clinical trial (T 1437/21)
Europe 12.04.2024
Recent EPO Board of Appeal decision T 1437/21 adds to a growing number of decisions concerning the patentability of second or further medical use inventions where the prior art relates to a clinical trial....
Register of Damage for Ukraine is open for claims submission
Ukraine 03.04.2024
On 2 April 2024, the Register of Damage for Ukraine opened the claims submission process for compensation for damage, loss or injury caused by Russian aggression against Ukraine. The launch took place...
Ukraine launches State Register of Sanctions
Ukraine 09.02.2024
On 29 January 2024, the President of Ukraine by the Decree No. 36/2024, approved the Decision of the National Security and Defence Council of Ukraine “On Approval of the Regulation on the State Register...
2024 – Topics that may Concern You
China 05.02.2024
In China, companies constantly have to deal with changes in regulations and new laws. This will also continue in 2024.Topics such as update to the PRC Company Law, adapting Joint Ventures in accordance...
What’s in a name? Updated EMA guideline on naming medicinal products processed through the centralised procedure comes into effect
EU, UK 30.01.2024
The updated EMA Guideline on the acceptability of names for human medicinal products processed through the centralised procedure was adopted by CHMP in December 2023 and came into effect on 1 January 2024. ...
Ukrainian healthcare authority takes further steps to introduce eCTD standard
Ukraine 23.01.2024
Through Order No. 1789 of 13 October 2023 (as further amended by the Order of the Ministry of Health of Ukraine No. 1924 of 8 November 2023), the Ministry of Health of Ukraine (MoH) inter alia introduced...
Ofsted under scrutiny – School inspections to resume on 22 January 2024 having been paused for inspectors to receive mental health awareness training
England and Wales 09.01.2024
The inquest into the devastating suicide of headteacher Ruth Perry sparked a national conversation about the impact of Ofsted inspections on school leaders and their well-being and whether the current...
Adapting to the new EU Data Act: implications for medical devices and other health devices
EU 08.01.2024
In recent years, the European Commission developed a European data strategy, which aims to create a single European market in which data can circulate freely. As the European Commission has emphasized...
Measures for Supervision and Administration of the Quality of Drug Supply and Use
China 05.01.2024
To implement the Drug Administration Law of the PRC, a draft version of the Measures for Supervision and Administration of Drug Supply was publicized in September 2019 for public opinion. After that, a...

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Top developments and predictions in the Life Sciences & Healthcare sector in Asia-Pacific

Navigating clinical trial disclosures: No reasonable expectation of success in a patient sub-population in view of prior art reporting phase III clinical trial (T 1437/21)

Register of Damage for Ukraine is open for claims submission

Ukraine launches State Register of Sanctions

2024 – Topics that may Concern You

What’s in a name? Updated EMA guideline on naming medicinal products processed through the centralised procedure comes into effect

Ukrainian healthcare authority takes further steps to introduce eCTD standard

Ofsted under scrutiny – School inspections to resume on 22 January 2024 having been paused for inspectors to receive mental health awareness training

Adapting to the new EU Data Act: implications for medical devices and other health devices

Measures for Supervision and Administration of the Quality of Drug Supply and Use

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