EMA: Public statement on the use of herbal medicinal products containing thujone

The HMPC prepared a public statement on the use of herbal medicinal products containing thujone, which is a natural constituent of the essentials oils of a number of plants widely used. Thujone ...

EMA: Draft guideline on clinical investigation of medicinal products in the treatment of schizophrenia

The main requirements for medicinal products developed for the treatment of schizophrenia, with regard to study design, patient population and outcome measures are described. Specific issues, ...

EMA: First clinical biomarker qualification released for public consultation

The European Medicines Agency has released the first qualification opinion for a clinical biomarker for public consultation. The biomarker is intended to identify patients who can be recruited for ...

EMA: Reflection Paper on Ethanol Content in Herbal Medicinal Products and Traditional Herbal Medicinal Products Used in Children

The scope of this paper is to reflect the need for safety limits for ethanol exposure by oral herbal medicinal products intended for the paediatric population. Establishing these limits is viewed ...

EMA: The linguistic review process of product information in the centralised procedure - Human

A linguistic review of product information in all EU languages is performed after the adoption of CHMP Opinions to ensure high quality and consistent product information of Centrally Authorised ...

EMA: Scientific guideline: ICH: Q 10: Note for guidance on pharmaceutical quality system

This guideline applies to the systems supporting the development and manufacture of pharmaceutical drug substances (i.e., API) and drug products, including biotechnology and biological ...

EMA: Scientific guideline: Reflection paper on stem cell-based medicinal products

The aim of this reflection paper is to cover specific aspects related to stem cell-based medicinal products for Marketing Authorisation Application. This reflection paper should be read in ...

EMA: Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for generic/hybrid applications

This document addresses a number of questions which users of the Centralised Procedure may have. It provides an overview of the EMA position on issues, which are typically addressed during the ...

EMA: Report on the survey of all paediatric uses of medicinal products in Europe

Regulation (EC) No 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use (hereafter referred as the “Paediatric Regulation”) aims to facilitate the ...

EMA: Reflection paper on the necessity of initiatives to stimulate the conduct of clinical studies with herbal medicinal products in the paediatric population

It is well documented that herbal medicinal products (HMPs) are widely used in the general population and specifically in children even if there are important differences among European countries ...

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