Assessment of medicinal products. Medical search. Frequent questions

The Committee adopted a reflection paper on risk management requirements for elemental impurities in veterinary medicinal products (EMA/ CVMP /QWP/153641/2018) following the close of the public consultation. (europa.eu)
The Committee also adopted a revised version of the document addressing the implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products (EMA/ CVMP /QWP/631010/2017-Rev.2). (europa.eu)
The European Medicines Agency have published: Scientific guideline: Draft guideline on implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products, draft: consultation open. (formiventos.com)
The phased-in implementation of the risk assessment of elemental impurities in veterinary medicinal products is to be in accordance with the decision tree indicated in this document. (formiventos.com)

3 years before the first administration of the investigational medicinal product (IMP). (who.int)
APEPTICO announced that it has supplied its Investigational Medicinal Product solnatide to the Medical University Vienna for the assessment of efficacy in COVID-19 patients. (who.int)

The product is not eligible for financial incentives in line with the guidance on the classification of veterinary medicinal products indicated for minor use minor species/limited market (EMA/ CVMP /388694/2014), which considers products for horses as generally not eligible. (europa.eu)
The Committee adopted questions and answers in support of the guideline on the assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicinal products (EMA/ CVMP /ERA/52740/2012). (europa.eu)
In order to allow time for regulators to elaborate guidance on the appropriate approach for a risk assessment for a veterinary medicinal product, the CVMP has adopted the following measured approach to the implementation of the monograph to existing veterinary products. (formiventos.com)
A national surveillance programme closely associating veterinary and medical surveillance systems should be established to enable assessment of the burden of zoonoses and animal-related hazards. (who.int)
Variations to the dossier related to a medical device and/or part of a medical device should be submitted in accordance with Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorizations for medicinal products for human use and veterinary medicinal products . (lifescienceleader.com)

Under the Misuse of Drugs (Modification) Orders, 2018 and updated in 2019, HSC has provided an exemption for certain products from various prohibitions in law r. (www.gov.gg)
VANCOUVER, British Columbia , Jan. 5, 2018 /CNW/ -- MYM Nutraceuticals Inc. (CSE: MYM) (CSE: MYM.CN) (OTC: MYMMF) (" MYM ") is excited to announce that Australia will expunge the export ban on cannabis products in February 2018 and allow the worldwide exportation of cannabis-based treatments such as oils, patches, sprays, lozenges and tablets. (newswire.ca)
k) to conduct a mid-term assessment of the implementation of this updated regional strategy by the end of 2018 and a final assessment by the end of 2023. (who.int)
Laws passed in 2018 made it legal to sell hemp and hemp products in the US. (medlineplus.gov)

The Reflection Paper follows the US FDA's similar May 2023 discussion paper, Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products . (dlapiper.com)

On 15 October 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Oxlumo, intended for the treatment of primary hyperoxaluria type 1 (PH1). (wikipedia.org)
If a model is generated for clinical trial purposes, "the full model architecture, logs from modelling, validation and testing, training data and description of the data processing pipeline" are likely part of the clinical trial data or trial protocol dossier and so should be made available for assessment at the time of marketing authorization or clinical trial application. (dlapiper.com)

The evidence did not show a reduction in opioid use in people prescribed medicinal cannabis. (nice.org.uk)

The methodological guideline "Process of information retrieval for systematic reviews and health technology assessments on clinical effectiveness" is currently under revision by IQWiG, NIPHNO and AETSA. (eunethta.eu)
On July 22, 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted for publication the guideline on quality documentation for medicinal products when used with a medical device (similar to "combination products" referred to by the US FDA), which will become effective January 1, 2022. (lifescienceleader.com)
This guideline focuses on product-specific quality aspects of a medical device and/or part of a medical device that may have an impact on the quality, safety, and/or efficacy of a medicinal product. (lifescienceleader.com)
This guideline explains the documents that should be submitted to demonstrate control of manufacturing and quality of the medicinal product in order to comply with applicable regulations. (lifescienceleader.com)
This guideline provides additional support for the electronic Common Technical Document (eCTD) format ( Volume 2B Notice to Applicants Medicinal Products for Human Use - Presentation and Format of the Dossier ). (lifescienceleader.com)
Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use. (janusinfo.se)
This guideline covers prescribing of cannabis-based medicinal products for people with intractable nausea and vomiting, chronic pain, spasticity and severe treatment-resistant epilepsy. (bvsalud.org)
This guideline covers the assessment and early management of fever with no obvious cause in children aged under 5. (bvsalud.org)

The review, carried out by EMA's Pharmacovigilance Risk Assessment Committee ( PRAC ), looked at the available data including studies evaluating whether the 2013 restrictions were followed in clinical practice. (europa.eu)
During its July 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommends new measures to minimise the risk of meningioma with medicines containing nomegestrol or chlormadinone. (famhp.be)
These provisional recommendations from the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) have been issued "as a precaution, to ensure that Zinbryta continues to be used as safely as possible while a review of its liver safety is ongoing," the agency said. (medscape.com)

Health Technology Assessment, 17 (7). (lse.ac.uk)
OHE lunchtime seminar with Leeza Osipenko (NICE Scientific Advice), Nancy Delvin and François Maignen (OHE) Health Technology Assessment (HTA) scientific advice (SA) was created by the National Institute for Health and Care Excellence in 2009. (ohe.org)
Health Technology Assessment (HTA) scientific advice (SA) was created by the National Institute for Health and Care Excellence in 2009. (ohe.org)

Medicines and Healthcare products Regulatory Agency (MHRA). (wikipedia.org)
Today EBE and EuropaBio's Joint Rare Diseases and Orphan Medicinal Products Task Force released an assessment of the EU's Orphan Medicinal Products (OMP) Regulation evaluating the extent to which this legislation has impacted research into rare diseases and the availability of new medicines to treat rare diseases over the last ten years. (euractiv.com)
Solaris's corporate mission is to deliver environmentally friendly, sun-grown medicinal-grade cannabis and to develop medicines and treatments for pain management and other medical conditions. (newswire.ca)
European Medicines Agency, EMA: Committee for Medicinal Products for Human Use (CHMP). (janusinfo.se)
To open a dialogue with developers, academics, and regulators, the European Medicines Agency (EMA) recently published a draft Reflection Paper on the use of Artificial Intelligence in the medicinal product life cycle . (dlapiper.com)
WHO medicines prequalification ensures that active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs) are safe, appropriate and meet stringent quality standards. (who.int)
In addition to medicines, WHO prequalification also covers immunization devices , in vitro diagnostics , vaccines and vector control products . (who.int)
More recent initiatives have sought to coordinate HTA SA across Europe and promote the integration of HTA SA with the advice provided by regulatory authorities (Medicines and Healthcare products Regulatory Agency, MHRA, and European Medicines Agency, EMA). (ohe.org)
Despite these efforts HTA SA is not routinely integrated into the clinical development of new medicines and it faces new challenges with the development of advanced therapy medicinal products, stratified medicines and medicines used in orphan diseases. (ohe.org)
The agency also recommends caution in using daclizumab in combination with medicinal products of known hepatotoxic potential, including nonprescription medicines and herbal supplements. (medscape.com)

The Committee reviewed the PSURs for Advocate , Credelio , Metacam and Novem , and recommended amendments to the product information . (europa.eu)
The committee noted that although use of cannabis-based medicinal products for intractable chemotherapy-induced nausea and vomiting would be short term, there was a lack of evidence on longer term adverse events, such as dependence and the development of psychological disorders. (nice.org.uk)
Evidence for the use of other cannabis-based medicinal products was limited and the committee were unable to make any practice recommendations. (nice.org.uk)
Therefore, the committee made another recommendation for research on the effectiveness of cannabis-based medicinal products in babies, children and young people with intractable nausea and vomiting. (nice.org.uk)

As part of the work of their Joint Task Force on Rare Diseases & Orphan Medicinal Products, EBE and EuropaBio commissioned this report to support the assessment of the impact of the regulation and to raise awareness of the pressing need to improve patient access to treatments for rare disease across the EU. (euractiv.com)
EuropaBio is the European Association for Bioindustries, bringing together bioscience companies from all fields of research and development, testing, manufacturing and distribution of biotechnology products. (euractiv.com)
EuropaBio would welcome a dialogue with the European stakeholders on the best way of ensuring equal and transparent measures for assessment, traceability, adverse event reporting, prescribing and dispensing for all follow-ons of a biologic originator. (europabio.org)

One efficient strategy towards this direction is the repurposing of already approved medicinal products [[ Medicinal products with a market authorisation in the EU. (europa.eu)
and repositioning of investigational products [[ Investigational products without a market authorisation in the EU. (europa.eu)

The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. (hpra.ie)
They recommended that healthcare professionals should think about these when considering nabilone and refer to the summary of product characteristics for further information on dosing, patient monitoring, contraindications and adverse events. (nice.org.uk)
The efficacy of Roop Matra Cucumber Ayurvedic Medicinal Face Wash was determined by measuring changes in parameters such as skin characteristics, skin appearance, and Global Acne Assessment (GAA) score. (who.int)

The Australian Federal Government has big ambitions for Australia to become the largest producer of medicinal cannabis products in the world. (newswire.ca)
MYM expects that exportation of cannabis products from Australia will be big business and could even outstrip domestic sales. (newswire.ca)

Anna Capasso , " Biologically Active Natural Products from Asia and Africa: A Selection of Topics ", Bentham Science Publishers (2021). (benthamscience.com)

With the guidance of a healthcare provider, a specific prescription CBD product (Epidiolex) has been used at higher doses and for longer durations. (medlineplus.gov)

In line with current tendencies of `new modes of governance', this essay introduces judicial tools which strike a balance between the respect for national autonomy in individual assessments and the effective implementation of Community law. (lu.se)

The model used data from the trials in the base-case analysis but also assumed a larger potential benefit from cannabis-based medicinal products in various sensitivity analyses. (nice.org.uk)

Using this review, ATSDR scientists are conducting public health assessments on X-10 iodine 131 releases, Y-12 mercury releases, K-25 uranium and fluoride releases, PCB releases from X-10, Y-12, and K-25, and other topics such as the Toxic Substances Control Act (TSCA) incinerator and off-site groundwater. (cdc.gov)

Legalization of medicinal and recreational cannabis use in numerous states within the USA has resulted in the increased commercial cultivation of cannabis. (cdc.gov)
Chapters in the book cover information about the cultivation, collection and processing of medicinal plants, the methods and high throughput techniques for isolation and characterization of bioactive phytochemicals and pharmacological screening for activity, formulation and quality control. (benthamscience.com)

EMA considers the use of AI/ML in individualizing treatment (including "patient selection, dosing, de novo design of product variants") as high-risk from a medicine regulation perspective, related to both patient risk and level of regulatory impact. (dlapiper.com)
The Government of Canada considers all information submitted by stakeholders and its inclusion in the screening assessment is based on factors such as its relevance to the screening assessment and confidential business information (CBI) status. (gc.ca)

Lumasiran: Public Assessment Report (PAR)" (PDF). (wikipedia.org)

A strategy towards human health risk assessment and ecotoxicological hazard evaluation must be developed and risk minimization measures to be sought for and applied. (degruyter.com)
Health hazard information is based principally on the weight of evidence based assessments of other agencies. (gc.ca)

The authors of this article have made a concerted effort to establish a risk assessment roadmap for LBPs and propose appropriate solutions for non-clinical programmes and First in Human clinical safety trials. (microbiometimes.com)

Undertake performance assessments using appropriate metrics. (dlapiper.com)

Kevin Loth, Senior Director, External Relations, Europe, Celgene Corporation, who also led the development of the assessment on behalf of the Task Force concluded: "The EU OMP Regulation has simultaneously boosted EU innovation and brought new therapies to market for patients with rare and debilitating diseases who otherwise have few or no treatment options. (euractiv.com)

They can describe advantages and disadvantages of medicinal treatments based on patients' experiences and what patients value from a new treatment. (eunethta.eu)

By applying this integrated research strategy, the MUTSPEC 2.0 project delineates signatures of various candidate carcinogens, including food contaminants (e.g. mycotoxins), dietary compounds, components of medicinal products, chemicals in tobacco smoke, and various environmental contaminants. (who.int)

Kimtata Vijay, Gupta Vishu, Singh Lakhbir, Ahmed Hasan Ali, Yogeesh H R. A Single Centre Open Label Post Marketing Surveillance Study to Evaluate the Efficacy and Safety of Roop Mantra Cucumber Ayurvedic Medicinal Face Wash. International Journal of Ayurveda and Pharma Research. (who.int)

Safety assessments (SA) of Investigational Medicinal Products (IMP) are standardised procedures used to evaluate adverse events ( AE s) and other reportable events during study conduct. (easy-gcs.ch)
Follow ethical principles defined in the guidelines for trustworthy AI and presented in the Assessment List for Trustworthy Artificial Intelligence for self-assessment (ALTAI) and conduct systematic impact analysis early on for each project. (dlapiper.com)

Information about the regulations specified for natural medicinal products in different region of the world is also presented, followed by a concluding chapter devoted to the role of natural herbal products for treatment of human diseases such as cancer, cardiovascular diseases, diabetes, obesity, inflammation and neurological disorders. (benthamscience.com)

The applicant for this medicinal product is Alnylam Netherlands B.V. Lumasiran was approved for medical use in the European Union and in the United States in November 2020. (wikipedia.org)

Following an assessment of baseline data, all subjects were given Roop Mantra Cucumber Ayurvedic Medicinal Face Wash for 30 days. (who.int)

The EMA said further details on these provisional measures will be provided in writing to healthcare professionals, and the product information will be updated accordingly. (medscape.com)
It aims to improve clinical assessment and help healthcare professionals diagnose serious illness among young children who present with fever in primary and secondary care. (bvsalud.org)

Extensive testing of CBMPs prior to patient administration is a regulatory obligation to assure safety and efficacy of products. (fluidimaging.com)
We treat all manufacturers equitably - we review product quality, safety and efficacy/performance without bias - and maintain confidentiality of proprietary information. (who.int)
The objective of the study was to assess the safety and efficacy of Roop Mantra Cucumber Ayurvedic Medicinal Face Wash in subjects with acne, facial scars, pimples, blemishes, dull skin and dry skin. (who.int)

Furthermore, our Joint Assessment report will document how the information from patients was considered in developing the scope of our EUnetHTA Joint Assessment. (eunethta.eu)
If the SP-INV disagrees with the causality assessment of the Site-INV, both opinions should be provided in the annual safety report . (easy-gcs.ch)
Therefore, we are committed to making the key messages of the patient submission publically available via our webpage by including them, verbatim, in the appendices of the assessment report. (scubacapsule.fr)
Report a suspected side effect or falsified product to the MHRA Yellow Card scheme. (medicines.org.uk)
A commentator suggested that the European Commission's (EC's) classification of 1,4-benzenediol as a Group 3 carcinogen and mutagen was misinterpreted in the draft screening assessment report. (gc.ca)
Also, the commentator mentioned that a published mode of action review for 1,4-benzenediol was ignored in the draft assessment report. (gc.ca)

The safety assessment itself poses particular problems because of the potential sensitivity of the target population, the "live" nature and the complicated mode of action of LBPs. (microbiometimes.com)
The dairy processing industry was highly affected because of the perishability of its products and time-sensitivity of both the supply and distribution chain. (academicjournals.org)

We have about 4800 species of plaints, among which about 800 plant species are known to have medicinal properties. (saujanyabooks.com)
5. Heinrich M, Chan J, Wanke S, Neinhuis C, Simmonds MS. Local uses of Aristolochia species and content of nephrotoxic aristolochic acid 1 and 2 - a global assessment based on bibliographic sources. (degruyter.com)
Uncertainties in evaluation of risk to human health following exposure to 1,4-benzenediol (e.g. species specific effects) have been acknowledged in the screening assessment document. (gc.ca)

The concise and organized layout along with a broad coverage of phytochemistry and drug discovery makes this book a suitable reference for students of medicinal chemistry, researchers and industry professionals interested in herbal product development. (benthamscience.com)

My research interest is phytochemical analysis of plant extracts, plant based food products and dietary supplements. (researchgate.net)
But there are still CBD products on the market that are labeled as dietary supplements. (medlineplus.gov)

To address this, we suggest that all follow-on products to biological medicinal products be treated in a consistent manner following biosimilar principles for the review and registration in EU. (europabio.org)

MYM Nutraceuticals Inc. is an innovative company focused on acquiring Health Canada licenses to produce and sell high-end organic medicinal cannabis supplements and topical products. (newswire.ca)

A first invitation to manufacturers of medicinal products for treatment of disorders caused by use of tobacco, to submit an Expression of Interest (EOI) for product evaluation has been published by the WHO Prequalification Unit (PQT). (who.int)
Information submitted in support of finished pharmaceutical products (FPPs) or active pharmaceutical ingredients (APIs) is assessed to determine whether these products meet the requirements and standards for WHO prequalification. (who.int)
We carry out - with integrity and accountability - timely and efficient prequalification of health products and other quality services in response to stakeholders' needs. (who.int)

While pharmaceutical guidelines for other biological products can be taken into account to design the relevant (non-)clinical development programmes, adapted guidelines on the safety assessment for LBPs are scattered and diverse. (microbiometimes.com)

Oxlumo Lumasiran Injection Product Monograph" (PDF). (wikipedia.org)

Alnylam Netherlands B.V. The Drug and Health Product Register, The Government of Canada. (wikipedia.org)
their medicinal and health benefits for humans and their domestic as well as companion animals along with their fruitful practical applications and perspectives like bioreactor for producing vaccine along with the methods that can increase their nutritional benefits. (scialert.net)
The Adult Mental Health Service, based at the Oberlands Centre, provides secondary care assessment, intervention, treatment and support service to people with m. (www.gov.gg)
The assessment, commissioned from the Office of Health Economics (OHE) Consulting, reveals that between 2000 and 2004, R&D investment in rare diseases in Europe increased by more than half and more than doubled between 2004 and 2008. (euractiv.com)
Australia's Health Minister Greg Hunt stated, "We would like to be, potentially, the world's number one medicinal cannabis supplier. (newswire.ca)
I oversee the management of a portfolio of clinical trials in mental health, involving the assessment of both investigative medicinal products and complex interventions. (imperial.ac.uk)
We assess products through a transparent process, adhering to best practices and published standards, focusing on public health needs, and carrying out scientifically-sound review of all available information in support of risk-based decision-making. (who.int)
We work with WHO Member States to ensure that their populations have equitable access to the good-quality health products they need. (who.int)
Prior to this public health assessment, ATSDR addressed current public health issues related to off-site areas, including the East Fork Poplar Creek area and the Watts Bar Reservoir area. (cdc.gov)
In spring 2004 ATSDR completed a public health assessment on Y-12 uranium releases and in this public health assessment evaluates radionuclides released from White Oak Creek. (cdc.gov)
IMSEAR is the collaborative product of Health Literature, Library and Information Services (HELLIS) Network Member Libraries in the WHO South-East Asia Region. (who.int)

However, the complexity and intrinsically fragile nature of these CBMPs create significant challenges in formulation development, analytical characterization, manufacturing, and stability assessment. (fluidimaging.com)

Follow-on products that have been classified differently have differing requirements for documentation, prescribing, dispensing and adverse event reporting despite referencing the same product and despite being present on the EU market simultaneously. (europabio.org)
Product safety was assessed by determining local intolerance and adverse effects of Roop Mantra Cucumber Ayurvedic Medicinal Face Wash. Results: The results of the study showed that applying Roop Mantra Cucumber Ayurvedic Medicinal Face Wash for 30 days significantly improved skin's characteristic and appearance. (who.int)

Provide robust and transparent selection mechanisms for prioritising already approved medicinal products or investigational products for repurposing, based on recognized unmet medical needs and sound preliminary data, and identify research priorities for the better understanding of mechanisms of action. (europa.eu)
There are different mechanisms of Maillard reaction to produce various final products via the formation of complex intermediates [ 3 , 5 , 6 ]. (hindawi.com)
Nowadays, it is still a great challenge to control the reaction in food quality, nutrition assessment, and medicinal aspects due to its unclear mechanisms. (hindawi.com)

R eliable analytical methods for characteriz ation of particles to determine product quality and stability are necessary. (fluidimaging.com)

Environmental pharmacology is the knowledge, study and the methods implemented for amalgamating the presence of pharmaceutical products and their metabolites in the environment. (degruyter.com)
Pharmaceutical and house care products and their metabolites gain access to the environment through various means and affect the flora and fauna and modulate the ecosystem. (degruyter.com)
APIs that meet assessment and inspection criteria are added to the WHO List of Prequalified Active Pharmaceutical Ingredients. (who.int)

Cell-based medicinal products (CBMPs) offer promising opportunities for the treatment of diseases with previously limited or no therapeutic options. (fluidimaging.com)

An article has been published in Frontiers in Medicine: Regulatory Science section, which proposes a new set of recommendations for addressing the various regulatory and technical challenges when assessing the safety of Live Biotherapeutic Products (LBPs). (microbiometimes.com)

EUnetHTA recently started a new Collaborative Assessment on a Medical Device for rectum spacers for prostate cancer radiotherapy. (eunethta.eu)
When the product information refers to a specific medical device that is to be used with the medicinal product, and the medical device is obtained separately by the user of the medicinal product (referred to as referenced). (lifescienceleader.com)
The MAH must ensure that when changes occur to a medical device and/or part of a medical device that is integral or co-packaged medicinal product, they are aware of any changes and determine whether updates to the eCTD are required. (lifescienceleader.com)

Anatomy13

Organisms66

Diseases2

Chemicals and Drugs35

Analytical, Diagnostic and Therapeutic Techniques and Equipment53

Psychiatry and Psychology4

Phenomena and Processes26

Disciplines and Occupations10

Anthropology, Education, Sociology and Social Phenomena25

Technology, Industry, Agriculture12

Humanities2

Information Science10

Named Groups3

Health Care48

Geographicals7

Elemental impurities in veterinary4

Investigational medicinal product2

Veterinary5

20184

20231

Authorization2

Prescribed medicinal cannabis1

Guideline8

Pharmacovigilance Risk Assessment Committee3

Technology assessment3

Medicines10

Committee4

EuropaBio3

Authorisation2

Characteristics3

Cannabis products2

20211

Guidance1

Implementation1

Analyses1

Substances1

Cultivation2

Considers2

Public Assessment Report1

Hazard2

Roadmap1

Undertake1

Regulation1

Treatments1

Chemicals1

Efficacy and safety1

Conduct2

Regulations1

20201

Baseline1

Healthcare2

Safety and efficacy3

Report6

Sensitivity2

Species3

Chemistry1

Dietary2

Biosimilar1

Nutraceuticals1

Prequalification3

Biological products1

Monograph1

Health11

Characterization1

Adverse2

Mechanisms3

Analytical1

Pharmaceutical3

Treatment1

Regulatory1

Medical Device3