Pharmaceuticals – Page 5
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EditorialClinical trials:
Ethical, ecological
and economic changeIn the pursuit of global – or even regional – standards in requirements to support medical product development; is industry keeping up? Can regulations and guidelines keep up with the pace of change?
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Industry newsGene therapy gives hope to patients with ‘butterfly skin’
FDA approves first gene therapy to treat dystrophic epidermolysis
bullosa patients – a condition sometimes called ‘butterfly skin’. -
JournalEvolution of GMO requirements for innovative investigational medicinal products upon transition to the EU CTR
The EU CTR replaced the EU CTD on 31 January 2022, which impacts investigational medicinal products that fall under genetically modified organisms (GMO-IMPs).
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JournalG-E-T-ting there – how gene editing technologies could change more than genes
The field of genome editing technologies (GETs) is rapidly advancing, marking a new and exciting era of curative medicines. These products can alter genetic material in patients, highlighting the crucial need to introduce dedicated legislation to ensure that GETs are developed and maintained in a safe and effective manner.
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JournalAlternatives to animal testing
in the development of ATMPsThis article looks at a range of innovative non-animal test methods, including in vitro tests based on human and animal cells, genomic technologies and in silico modelling.
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JournalRegulatory guidelines for
nutraceuticals in IndiaThe regulatory landscape for nutraceuticals in India, and the required approval processes for market
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JournalEnsuring promotional
materials’ compliance
in the EUDirective 2001/83/EC is the EU legislation specifically covering promotional materials for the pharmaceutical industry – notably, Title VIII Advertising and Title VIIIa Information and Advertising. This is in addition to general consumer protection laws and unfair commercial practices regulations and directives. While Directives are legally binding and directly applicable to all companies. Some granularities can be introduced when it is transposed into national legislation by Member States (MS) individual legislatures.
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JournalRegistration and post-approval variation of pharmaceutical drugs in Latin America:
challenges and opportunitiesThis article provides an overview of the critical challenges for pharmaceutical drug registration and post-approval changes for manufacturers in six major Latin American countries.
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JournalAn overview of the regulatory framework for advanced therapies
Advanced therapy medicinal products (ATMPs) have recently advanced in development and are subject to regulation in some markets. This article summarises the regulatory framework for ATMPs in some of the markets where these requirements are in place: Argentina, Brazil, Europe, and the US.
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JournalIs consulting in regulatory affairs your next career path?
Navigating the corporate ladder isn’t always clear cut. Along the way you may move in and out of the industry, stay in one position for too long, or even jump from specialist to director. Some ditch the politics all together and become their own boss. What is it like being a consultant, contingent worker, or contractor?
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JournalEnvironmental impact of pharmaceuticals and regulation in the EU
The profound impact of pharmaceuticals on the environment has been acknowledged for decades. In the EU, two key mechanisms that assess this risk are the Environmental Risk Assessment (ERA), and Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). As both frameworks are under assessment, this article looks at the key considerations within the ERA.
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JournalAccelerated regulatory pathways: Vaccines for tropical diseases
Reproduced from an online seminar presentation, made in collaboration with TOPRA and hVIVO, given on 21 June 2022 by Bruno Speder from hVIVO.
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JournalPatient information — why do things go wrong?
Are common root causes leading to the pharmaceutical industry being non-compliant with the legal obligation to keep authorised product information up to date?
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JournalA View of…The Environmental Impact of Pharmaceuticals
The body of research being published which is focused on the environmental impact of pharmaceuticals is increasing rapidly. It highlights a growing concern among the public for medicinal products accumulating in the natural world through a variety of originating sources.
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JournalAn integrated approach to collecting patient experience data: An industry perspective
Patient experience data (PED) are intended to provide information about patients’ experiences with a disease or condition. There is growing interest from multiple stakeholders, including pharmaceutical companies to collect PED to inform the development and commercialisation of new drugs. Present efforts to generate PED ofen result in disjointed, overlapping, or duplicated efforts within and between pharmaceutical companies.
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JournalConsiderations for sponsors when producing an EU IMPD: Impact of the EU-CTR
European Union (EU) pharmaceutical legislation – known as the Clinical Trial Regulation (EU-CTR), came into effect on 31 January 2022. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a wider scale, with high standards of public transparency and safety for clinical trial participants.
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JournalEuropean regulatory fees – complexity, concerns and solutions for efficiency
Regulatory authorities charge fees for the services they provide related to marketing authorisations. This research aimed to understand the complexity and concerns around the fee calculation and payment process for EU procedures used for market approval of a drug and proposes potential solutions to improve efficiency.
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JournalBreakthrough therapy designation: From serious diseases to opioid crisis prevention
Following the human immunodeficiency virus crisis of the 1980s, the US Congress and US Food and Drug Administration (FDA) introduced several regulatory initiatives. The purpose was to expedite FDA review and approval of products to overcome the longer traditional pathway review timelines. One such process enabling faster approval is the ...
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JournalThe worldwide acceptance of non-legalised eCPPs
The transition from paper-based format to electronic Certificates of Pharmaceutical Product (eCPPs) has seen an increased uptake as a result of the operational limitations associated with the COVID-19 pandemic. While issuing regulatory agencies (RA), such the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) now offer ...