Designing a CMC strategy for advanced therapy medicinal products in EU

2012
SCRIP Regulatory Affairs

Valerie Pimpaneau and Anne Dupraz Poiseau discuss the latest EU guidelines on ATMPs and explain how to develop a solid chemistry, manufacturing and control strategy for such products.

Development of orphan products and the impact of the EU Paediatric Regulation ,TOPRA Vol 9, No.10

2012
Regulatory Rapporteur

Development of orphan medicinal products (OMPs) is challenging by nature: knowledge is usually limited; the patient population are small and often frail; and the implementation of the Paediatric Regulation in the EU has added a layer of complexity, especially for OMPs.

Nutraceuticals and functional food regulations in key emerging markets Part I ,TOPRA Vol 9, No.5

2012
Regulatory Rapporteur

Nutritionals & Nutraceuticals describe the group of products occupying the grey zone between food and medicines and having recognisable health and physiological benefits attributable to the efficacy of their consumption. In the more developed markets, these products have increasingly experienced more stringent regulatory controls for the primary reasons of product safety, public health and consumer protection.

Applying for multinational EU Trials can be faster via voluntary harmonisation procedure

2012
SCRIP Regulatory Affairs

Using the voluntary harmonisation procedure to apply for permission to conduct multinational clinical trials across the EU can, in some cases, lead to faster trial authorisations, compared with using the traditional application approach.

US&EU Regulations for drug delivery systems: development considerations for innovate products

2012
SCRIP Regulatory Affairs

Marielle Fournier and Anne Dupraz-Poiseau describe US and EU rules governing prefilled syringes, pen injectors and innovative drug-delivery systems for biologics and consider the safety, quality and efficacy development challenges for manufacturers.

Hybrid or Mixed Marketing Authorization Application in the EU: not a trivial decision in new development programs for established drugs

2012
Drug Information Journal

For any medicinal product Marketing Authorization Application (MAA) in the European Union, the applicant needs to indicate the legal basis for the application. This legal basis, laid down in Directive 2001/83/EC as amended, determines the dossier content, the market exclusivity, and the pediatric requirements in a significant way.

Biomarkers qualifications: a first step towards companion diagnostic development

2011
SCRIP Regulatory Affairs

Biomarker qualification can be a first step towards companion diagnostic development. The European Medicines Agency already has a biomarker qualification process and the US Food and Drug Administration is developing one itself. The two agencies should find a way to harmonise their respective processes and propose clear incentives for companies seeking to use them.

Considerations on paediatric investigation plans for advanced therapy medicinal products,TOPRA Vol 8, No.10

2011
Regulatory Rapporteur

In Europe, advanced therapy medicinal products (ATMPs) are subject to the requirements laid down in the Paediatric Regulation. A company developing an ATMP must therefore obtain agreement from the EMA on a paediatric investigation plan (PIP) or waiver prior to submitting its marketing authorisation application (MAA).

Telemedecine and E-health systems, (WPMC 2011 Workshop)

2011
FEELIT

A long standing challenge for regulators has been how to incorporate new technologies into the current regulatory framework. This is especially applicable to telemedicine and e-health systems.

Activities to improve the regulatory framework for companion diagnostics step up

2010
SCRIP Regulatory Affairs

Personalised medicine aims to provide the right treatment to the right patient, at the right dose and at the right time. this paper discusses how the regulatory process for companion diagnostics might be improved to realise the potential of personalised medicine.

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