The discovery of the endocannabinoid system has raised public interest in the medicinal use of cannabis, phytocannabinoids, and synthetic cannabinoids, which has always been closely regulated due to their psychotropic effects and potential abuse. The review takes a quick look at the current legal framework in the European Union, which regulates cannabis use and cultivation for medicinal purposes in line with the United Nations Conventions on the production, trade, and use of cannabis, phytocannabinoids, and synthetic cannabinoids. And while the EU legislation precisely defines requirements and marketing authorisation procedures for medicinal products for all EU member states, there is no common regulatory framework for magistral and officinal preparations containing cannabinoids, as they are exempt from marketing authorisation. Instead, their regulation is left to each member state, and it is quite uneven at this point, mainly due to cultural and historical differences between the countries, leading to different access to non-authorised medicinal products. Therefore, to meet great public interest, harmonised approaches on cannabinoid-containing products without marketing authorisation would be welcome to level the playing field in the EU.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7837236 | PMC |
| http://dx.doi.org/10.2478/aiht-2020-71-3302 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Expert opinion on Centiloid thresholds suitable for initiating anti-amyloid therapy. Summary of discussion at the 2024 spring Alzheimer's Association Research Roundtable.
J Prev Alzheimers Dis
January 2025
Memory & Aging Center, Departments of Neurology, Radiology & Biomedical Imaging, University of California San Francisco, San Francisco, California, USA.
A 24-30 Centiloid (CL) threshold was collectively considered by a group of global dementia experts as a practical and implementable cut-off for anti-amyloid therapy intervention, in Alzheimer's disease patients who have been diagnosed at the mild cognitive impairment or mild dementia stage of their disease. Though additional validation is needed, knowledge of this threshold would be valuable to those involved in diagnosing and treating patients in the new AD care pathways, as well as entry into clinical trials. Therapy monitoring to determine future treatment response and assess amyloid clearance can be accomplished with amyloid PET with some technical details still to be elucidated.
View Article and Find Full Text PDFDo European regulatory measures accelerate national market access in Belgium? A retrospective analysis of medicines centrally authorised between 2015 and 2020.
BMJ Open
January 2025
Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium
Background: At the European level, several regulatory measures (ie, priority medicines (PRIME) scheme, accelerated assessment, conditional marketing authorisation and authorisation under exceptional circumstances) are in place with the aim to expedite the marketing authorisation process for medicines targeting unmet medical needs (UMNs). However, the potential impact of these measures on subsequent decisions regarding market access at the national level, and ultimately if medicines making use of these supporting measures reach the patient earlier, remains unclear.
Objectives: This study seeks to (1) assess the impact of such European regulatory measures on the number of successful applications and time to reimbursement of this group of medicines in the national context of Belgium and (2) evaluate the association between the application of European regulatory measures and Belgian measures (ie, early access pathways and managed entry agreements).
Pharmacovigilance systems for safety monitoring of herbal medicines: assessment of the national regulatory authority, manufacturers and marketing authorisation holders in Tanzania.
J Pharm Policy Pract
December 2024
School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Background: The increase in the consumption of herbal medicines and their documented adverse reactions (ARs) necessitate countries to have good pharmacovigilance (PV) systems at all levels. PV systems should be frequently assessed in a systematic manner with available harmonised tools to monitor the implementation of efforts, strengthen the systems and identify areas for improvement.
Objectives: This study aimed to assess the performance of pharmacovigilance and its quality systems for monitoring herbal medicine safety at the National PV Centre at the Tanzania Medicines and Medical Devices Authority (TMDA), manufacturers and herbal medicine marketing authorisation holders (MAHs) to identify gaps, challenges and opportunities for improvement.
The London money market and non-British bank lending during the first globalisation: evidence from Brazil.
Cliometrica (Berl)
April 2024
Faculty of History, University of Oxford, Oxford, UK.
Article Synopsis
- This study explores how the London money market influenced credit offered by German banks in Brazil during the early globalization period (1889-1913).
- It finds that higher demand for foreign bills and lower borrowing costs in London led to increased credit supply.
- By using annual tax payments as an instrumental variable, the research establishes a causal relationship and fills a gap in the literature about London's role in global finance and foreign banking history.
Janus-kinase inhibitor use in immune-mediated inflammatory diseases beyond licensed indications: A scoping review.
Autoimmun Rev
December 2024
Rheumatology Department, Guy's and St Thomas' NHS Trust, London, United Kingdom.
Introduction: The use of Janus kinase inhibitors (JAKis) in immune-mediated inflammatory diseases (IMIDs) beyond licence is expanding rapidly. The aim of this scoping review was to identify and present the available evidence on the efficacy of JAKis in all conditions without marketing authorisation.
Methods: Through a systematic literature search we identified studies including 5 or more patients that assessed the use of any JAKi for any efficacy outcome.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!