Dataset Information

EU Regulatory Pathways for ATMPs: Standard, Accelerated and Adaptive Pathways to Marketing Authorisation.

ABSTRACT: Advanced therapy medicinal products (ATMPs) require evaluation by the European Medicines Agency's Committee for Advanced Therapies prior to being placed on the European market, subject to a Marketing Authorisation granted by the European Commission. In common with other medicinal products, various regulatory pathways are available for taking ATMPs through clinical trials to market authorisation, and the regulatory pathway taken will depend on a product's characteristics and the target patient population. With the industry poised to deliver more late-stage clinical and commercial ATMPs for serious diseases with high unmet medical need (e.g., T cell immunotherapies for cancer), bringing medicines to patients through optimized regulatory strategies and expedited pathways is assuming greater importance. The European Medicines Agency's priority medicines (PRIME) scheme was introduced in 2016 specifically to enable this, and eligibility has been granted to 19 ATMPs as of the fourth quarter (Q4) 2018. Furthermore, two chimeric antigen receptor (CAR) T cell therapies, Yescarta and Kymriah, have recently completed their journeys through the scheme to Marketing Authorisation. This review discusses how the regulatory pathway for any particular ATMP, with or without PRIME designation, is determined and navigated.

SUBMITTER: Detela G

PROVIDER: S-EPMC6378853 | biostudies-other | 2019 Jun

REPOSITORIES: biostudies-other

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EU Regulatory Pathways for ATMPs: Standard, Accelerated and Adaptive Pathways to Marketing Authorisation.

Detela Giulia G Lodge Anthony A

Molecular therapy. Methods & clinical development 20190129

Advanced therapy medicinal products (ATMPs) require evaluation by the European Medicines Agency's Committee for Advanced Therapies prior to being placed on the European market, subject to a Marketing Authorisation granted by the European Commission. In common with other medicinal products, various regulatory pathways are available for taking ATMPs through clinical trials to market authorisation, and the regulatory pathway taken will depend on a product's characteristics and the target patient po ...[more]

PMID: 30815512

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Project description:BACKGROUND:A variety of nutrient profiling models have been developed to restrict food marketing to children. Previous assessments have shown substantial differences in terms of model strictness and agreement, but EU-wide data on how leading products in the various national markets perform against these health-minded nutrition criteria are unavailable. OBJECTIVE:To evaluate the nutritional composition of the pre-packaged food offer in selected categories sold at scale in the EU using criteria of two nutrient profile models intended to restrict food marketing to children. METHODS:The nutrient profile models of the private-sector EU Pledge and of the World Health Organization's Regional Office for Europe were applied to a commercial database with sales and nutritional information of 2691 pre-packaged products from five product categories (breakfast cereals, ready meals, processed meat, processed seafood, and yoghurts) and 20 EU countries. This study describes the criteria not met, the product ineligibility rates, and the distances to the various criteria thresholds. FINDINGS:Between 48% (EU Pledge) and 68% (WHO Europe) of the 2691 products analysed were found to be ineligible for marketing to children. The criteria thresholds most often not met were those for total sugars (in breakfast cereals, yoghurts), salt (in processed meat, processed seafood, ready meals), and fibre (in breakfast cereals). Total and saturated fat criteria also played a substantial role in rendering yoghurt products ineligible, and the energy criterion did so for ready meals. INTERPRETATION:A large number of food products selling at scale in the EU do not meet the criteria of two EU-level nutrient profile models intended to restrict food marketing to children. Given the considerable market share of many such products, they are likely to be consumed widely and in some cases regularly, including by children, even without being marketed to them. Nutrient profile models could serve as benchmarking tools for monitoring and evaluating food product reformulation efforts.

Dataset Information

EU Regulatory Pathways for ATMPs: Standard, Accelerated and Adaptive Pathways to Marketing Authorisation.

Publications

EU Regulatory Pathways for ATMPs: Standard, Accelerated and Adaptive Pathways to Marketing Authorisation.

Similar Datasets

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