All Journal articles – Page 9
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JournalImpact 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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JournalDecentralised 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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JournalReappraisal 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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JournalMedical device standards update: June 2023
This edition of our regular column updates the progress of applicable standards to March 2023.
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JournalImplementation 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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JournalA 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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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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JournalDoes sole dependence on reliance models contribute to a sustainable healthcare ecosystem?
Governments should strive for a sustainable and global regulatory framework adept to deal with a healthcare crisis and similar issues that may arise in the future. This article looks at regulatory frameworks in international regions through AstraZeneca’s experience with the VaxzevriaTM vaccine.
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JournalThe transition period of the new API framework in Brazil is coming to an end
The new active pharmaceutical ingredients regulatory framework in Brazil begins August 2023
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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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JournalContraceptive product registration:
regional harmonisation through the East African Community mechanismThe COVID-19 pandemic disrupted access to contraception as a result of supply chain challenges, staff shortages and lockdowns, to name a few. This article looks at Catalyst Global’s experience in registering the contraceptive product, AVIBELA, using the East African Community Medicines Regulatory Harmonisation Initiative.
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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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