The Clinical Trials Regulation (CTR), effective from January 31, 2022, introduced a pivotal change in the EU’s clinical trial landscape. Transitioning from the previous Clinical Trial Directive (CTD) to the CTR involves submitting a streamlined “transitioning application” before January 30, 2025. This regulatory evolution underscores efficiency and transparency in clinical trials, urging sponsors to initiate the transition process promptly for uninterrupted trial continuity under the CTR.
... Read moreBoth the Belgian legislator and government have played an active role in 2023 when it comes to pharma legislation, which has led to a number of changes in the legal framework. In this article, we look back and discuss five noteworthy developments in Belgian pharma law.
... Read moreDespite many initiatives by the (former) Minister of Health, the uptake of biosimilars in Belgium has remained rather low. In this blog, we summarise the new rules, which apply since 2 October 2023.
... Read moreGlobal pharmaceutical industry has become the field for serious patent-related battles between producers of original drugs and manufacturers of generics.
Particularly this trend is widely observed in EAEU and CIS, where the regulatory bodies and courts have not yet developed an efficient mechanism for maintaining the balance of interests between the pharmaceutical businesses, state and patients.
Having vast expertise in providing legal protection to large Russian and international pharmaceuticals and healthcare companies in EAEU and CIS, Lidings publishes Legal Digest highlighting the most notable patents disputes in Life Sciences that have been recently taking place in those jurisdictions.
... Read moreDuring the Covid 19 pandemic, a healthcare compliance “classic” has largely faded into the background: The permissibility of hospitality for healthcare professionals by representatives of the pharmaceutical and medical device industries. After the end of the pandemic, however, face-to-face meetings are coming back to life. And so it is not surprising that the question now also arises again as to whether and to what extent physicians, dentists, pharmacists, nurses, practice staff and other healthcare professionals (“HCPs” for short) may actually be invited to lunch or dinner. Some changes have happened recently, particularly with regard to value limits – including new versions for important codes.
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