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Polish Ministry of Health: Regulation amending the Regulation on determination and payment of charges related to marketing authorisations in respect of medicinal products

02.03.2011
Regulation of the Minister of Health amending the Regulation on determination and payment of charges related to marketing authorisations in respect of medicinal products ...

EMA: Guideline on medicinal products for the treatment of insomnia

25.02.2011
This Guideline should be considered as general guidance on the development for medicinal products for acute and long-term treatment of insomnia. Its main focus is on primary insomnia, however, it ...

GMP: New EMA/HMPC Reflection Paper on Stability of Herbal Medicinal Products

24.02.2011
This reflection paper addresses the need for specific requirements for establishing the stability of herbal medicinal products (HMPs). The quality, including the stability, of HMPs should be ...

EMA: Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues

22.02.2011
The European Medicines Agency has published concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: ...

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

22.02.2011
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

22.02.2011
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

17.02.2011
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

09.02.2011
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

07.02.2011
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

07.02.2011
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 ...