Practical Updates in Primary Care的动态

?? The #Australian #TherapeuticGoodAdninistration (TGA) has published a new #MedicalDevice regulation changes on 26-June-2024. ?? Changes have been made to the regulation of: - #software-based medical devices - prescription spectacle lenses - medical devices containing #microbial, #recombinant, or #animal #substances - medical device application #audit requirements. ?? The changes came into effect on 15 June 2024 for:? - software-based medical devices - prescription spectacle lenses. ?? The changes will come into effect on 1 July 2024 for:? - medical devices containing microbial, recombinant, or animal substances - medical device application audit requirements. ?? You can find the new released version here: https://lnkd.in/dQQHqB3j

Our BMJ med study developed indicators for representation in clinical research. We applied the indicators to assess 50 #pharma companies' #clinicaltrial diversity #policies. Indicators include: (1) use of enrollment targets that reflect the prevalence of targeted conditions in populations, (2) broad eligibility criteria in trials, (3) diverse workforce, (4) identification and remedy of barriers to trial recruitment and retention, (5) incorporation of patient input into trial design, (6) advancing public health literacy, (7) multidimensional approaches to diversity, (8) selection of sites with diverse providers and patient populations, (9) data collection after product approval, (10) diverse enrollment in every country where trials are conducted, (11) diverse enrollment should be a focus for all phases of clinical trials, not just later stage or pivotal trials, (12) varied trial design, (13) expanded access, and (14) public reporting of trial participant demographics. We found 48% (24/50) of companies had no #publicpolicy on representation in clinical trials; among those w policies, content varied widely. Large companies were more likely to have a public policy than non-large (84% v 20%, P<0.001). Large companies most frequently committed to using epi based trial enrollment targets representing the prevalence of indicated conditions in various populations (71%), dealing w barriers to trial recruitment (71%), & improving patient awareness of trial opportunities (67%). Company location was not associated w having a public diversity policy (P=0.17). The average company policy had 5 of the 14 commitments recommended in FDA, IFPMA PhRMA European Medicines Agency & other stakeholder guidance. Our findings show that many pharmaceutical companies do not have public policies on diversity in clinical trials, although policies were more common in large than non-large companies. Policies that were publicly available varied widely and lacked important commitments recommended by stakeholder guidance. These findings suggest that corporate policies can be better leveraged to promote representation and fair inclusion in research, and implementation of FDA and stakeholder guidance. Thx to coauthors Joseph Ross Cary Gross Reshma Ramachandran Jason Schwartz Michael Mensah Sakinah Carter Suttiratana Will Pelletiers

For International Clinical Trials Day, I am sharing this video that speaks to me about awareness for clinical trials. Clinical trials have helped bring incredible new therapies to patients, and this cannot occur without the participation of the people and patients who volunteer to enter these trials. My gratitude today goes to these people. MT Pharmacy (https://lnkd.in/eT8wcCWP) #InternationalClinicalTrialsDay

MARIJUANA is a MIND ALTERING DRUG w/ NUMEROUS TERRIBLE ATTRIBUTES! Marijuana, also known as cannabis, can have many negative effects, including ***Mental health> Marijuana can increase the risk of mental health issues like depression, social anxiety, and schizophrenia. It can also cause psychotic episodes that include paranoia, delusions, and hallucinations.***Brain development>Marijuana can harm brain development, especially in adolescents. It can impair memory, learning, concentration, and attention. ***Physical health >Marijuana can harm the lungs, causing bronchitis, lung infections, and chronic cough. It can also increase the risk of stroke, heart disease, and other vascular diseases. ***Driving >Driving under the influence of marijuana can be dangerous, causing slower reactions, lane weaving & decreased coordination. ***Addiction > Marijuana can be addictive, and people who use it may develop a tolerance and need more and more to achieve the same effects ***Pregnancy > Using marijuana while pregnant can affect the baby's development, increasing the risk of lower birth weight, preterm birth, stillbirth, and brain and behavioral problems. ***Withdrawal > When trying to quit, people may experience withdrawal symptoms like irritability, restlessness, difficulty sleeping, and hot flashes. ***Cannabinoid hyperemesis syndrome (CHS) >CHS is a serious condition that some people experience after using cannabis. *** Delta-8 THC is another intoxicating cannabinoid found in the cannabis plant. Products containing delta-8-THC have not been FDA-approved for safe use, and eating large amounts can lead to medical emergencies.

Use of market authorisation evidence from comparable overseas regulators and assessment bodies for medical devices (including IVDs) To abridge TGA conformity assessments and for ARTG inclusion applications https://lnkd.in/dFWvGtmb

Updates to Australian Medicine Labelling Rules: A Step Towards Enhanced Safety The Therapeutic Goods Administration (TGA) proposes significant updates to the labeling rules for medicines under TGO 91 and TGO 92. These changes aim to enhance medicine safety by improving the clarity and accessibility of critical information for health professionals and consumers. Key Proposals: 1. More transparency of active ingredient quantities in injectable medicines. 2. Improved instructions for the preparation and storage of certain injectable medicines. 3. Enhanced information on labels regarding large oral dosage forms to prevent choking incidents. Have Your Say: Your feedback is crucial. Participate in the consultation by reading the consultation paper and submitting your views. https://lnkd.in/ecpMJWxb #RegulatoryUpdates #MedicineSafety #TGA #HealthProfessionals #ConsumerSafety

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MHRA: New Rules for Manufacturers and Wholesalers after Brexit (Sep 2024) The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published new guidance for pharmaceutical manufacturers and wholesalers in order to implement the arrangements of the Windsor Framework for human medicines. The rules will apply from 1 January 2025. ? It covers labeling, packaging, and importing requirements for human medicines, including the use of 'UK Only' labels and the disapplication of the EU Falsified Medicines Directive (FMD). Specific instructions are given for Qualified Persons (QPs) and Responsible Persons for Import (RPis). Key Points: Labeling: Medicines must display a 'UK Only' label, starting January 1, 2025. Wholesalers should ensure that, when importing goods under the RPi process, the goods that are QP certified after midnight on 31 December 2024 are compliant with the conditions of MHRA guidance and feature 'UK Only'. FMD Disapplication: EU Falsified Medicines Directive will no longer apply, FMD-compliant barcodes must be fully removed or covered. Activities performed in Northern Ireland: All new medicines and medicines in Northern Ireland that currently fall under the scope of the EU Centralised Authorisation Procedure will be authorised by the MHRA for the UK market. Joint packs between the UK and EU will no longer be possible. Northern Ireland based QPs who are named on a Northern Ireland GMP authorisation may continue to perform batch certification for both UK and EU markets. EU/EEA Storage facilities: It will no longer be possible to utilise EEA located storage facilities to store 'UK Only' labelled medicines. That means it will no longer be possible to send goods into the EEA from the UK for storage purposes. For more details, see?MHRA link below: https://lnkd.in/euRVGYsp

In this episode of Heath Wealth, my colleague Dr. Kausik Maiti delves into the importance of pharmacovigilance in healthcare, India’s low rate of adverse drug reaction reporting compared to global standards and how patients can help. Watch it here ?? #pharmacovigilance #healthpodcasts