All Journal articles – Page 6
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Warning letters for direct-to-consumer advertising: a five-year retrospective analysis
Background: Direct-to-consumer pharmaceutical advertising (DTCPA) is a ‘grey area’ that the Food and Drugs Administration (FDA) in the United States (US) regulates through the Centre for Drug Evaluation and Research (CDER). One of the purposes of DTCPA is to educate and empower patients via popular media such as television, radio, ...
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EU versus Rest of the World regulatory frameworks and requirements for human tissue-based products
After participating in and/or hosting over 100 global competent authority inspections, the only true consistency is that no two inspections are the same. I see so many companies try to predict the inspectors approach, agenda…even the physical route they will take prior to the audit. Some upfront risk assessment and ...
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A year of clinical trials under IVDR:
a sponsor’s perspectiveThe new EU in vitro diagnostic medical devices regulation (IVDR) extends to medical use of in vitro diagnostics (IVDs) in clinical trials, in addition to marketed IVDs. Although compliance to some aspects has been required since the Date of Application on 26 May 2022, there has been ...
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Regulatory challenges and opportunities facing hearing aid manufacturers in Europe
In a world where many people are living longer but not all are living well and age-related hearing loss affects approximately 20% of the European population aged 65 or older – hearing aids address a medical need which for the most part remains unmet. With increasing evidence ...
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African Medicines Agency and a new African regulatory ecosystem
Regulatory Rapporteur July/August 2023 | Volume 20 | No.7 Introduction and background The African medicines regulatory landscape is evolving rapidly. The African Medicines Agency (AMA) is being established as a Specialised Agency of ...
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A critical review and comparison of the processes when seeking Scientific Advice in the EU and the USA – Part 2
GRAY, MSc − PART TWO OF A TWO-PART SERIES(See part 1 here) Scientific Advice (SA) is provided by all major regulatory agencies to pharmaceutical companies and other interested parties who are developing new medicines. Regulatory agencies such as EMA and FDA regard provision of SA as a ...
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Impact of clinical data requirements following EU MDR (2017/745) & Clinical Evaluation Guidance (MEDDEV 2.7/1 Rev 4)
The EU Medical Device Regulation 2017/745 (EU MDR) and guidance on clinical evaluation (MEDDEV 2.7.1 Rev 4) have replaced the previous regulations governing the placing of medical devices on the European market. Concerning that these new requirements may be difficult to implement and pose an additional burden to Medical ...
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Decentralised clinical trials –
A European Union recommendation paperDecentralised clinical trials (DCTs) have undergone a rapid development over the last three years. This article focuses on the recently published European Union (EU) recommendation paper which provides consolidated guidance for sponsors planning DCTs irrespective of any health-related crisis, as part of the Accelerating Clinical Trials in the European Union ...
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Reappraisal of regulation of agricultural and veterinary chemicals in Australia
Agricultural and Veterinary (Agvet) chemical products are registered with the Australian Pesticides and Veterinary Medicines Authority (APVMA) before they can be supplied in Australia. A mandatory scheme was introduced by the Australian government in 1993 to transfer Agvet chemical products from the State-based system to a national ...
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Medical device standards update: June 2023
This edition of our regular column updates the progress of applicable standards to March 2023.
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Implementation of Regulation (EU) No 536/2014 – A CRO perspective
Significant changes have been implemented to the clinical trials application process with Regulation (EU) No 536/2014 (European Union Clinical Trials Regulation; EU CTR) taking effect on 31 January 2022. This article summarises experience gathered under the new regulatory framework from a contract research organisation (CRO) perspective working ...
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A critical review and comparison of the processes when seeking scientific advice in the EU and the USA – Part 1
GRAY, MSc − PART ONE OF A TWO-PART SERIES(See part 2 here) Scientific Advice (SA) is provided by all major regulatory agencies to pharmaceutical companies and other interested parties who are developing new medicines. Regulatory Agencies such as EMA and FDA regard provision of SA as a core ...
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Evolution 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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G-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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Alternatives 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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Regulatory guidelines for
nutraceuticals in IndiaThe regulatory landscape for nutraceuticals in India, and the required approval processes for market
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Ensuring 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.