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EMA: Concept paper for a guideline on limits for genotoxic impurities

24.01.2013
In the absence of guidance on limits for genotoxic impurities in veterinary medicinal products, the Committee for Medicinal Products for Veterinary Use (CVMP) recommends the development of a ...

EMA: Concept paper for a guideline on antimicrobial-resistance risk assessment

24.01.2013
The Committee for Medicinal Products for Veterinary Use (CVMP) intends to draft a guideline on antimicrobial-resistance risk assessment to be applied for all classes of antimicrobial agents. The ...

FDA: Guidance for Industry Providing Submissions in Electronic Format - Summary Level Clinical Site Data for CDER’s Inspection Planning

24.01.2013
This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and ...

EMA: European Medicines Agency updates guideline on evaluation of anticancer medicines

17.01.2013
The European Medicines Agency has finalised the revision of its guideline on the evaluation of anticancer medicinal products. This revision includes, amongst other topics: the use of biomarkers as ...

EMA: Draft guideline on clinical investigation of medicinal products for the treatment of acute heart failure

17.01.2013
The CHMP Note for Guidance on the Clinical Investigation of Medicinal Products for the Treatment of Cardiac Failure (CHMP/EWP/235/95, rev. 1) provides limited regulatory guidance for development ...

EMA: Concept paper on the need for a paediatric addendum to the guideline on clinical investigation of medicinal products for the treatment of acute heart failure

17.01.2013
The CHMP guideline on the clinical investigations of medicinal products for the treatment of Acute Heart Failure (AHF) addresses the development issues in this specific patient population but is ...

MHRA: Guidance on EU Commission Regulation 207/2012 on electronic labelling of medical devices

17.01.2013
This Regulation which comes into force on 1 March 2013 allows manufacturers of certain types of medical devices and accessories to provide electronic instructions for use if they wish and lays ...

EMA: Draft guideline on pharmaceutical development of medicines for paediatric use

10.01.2013
This guideline is intended to provide additional guidance for the pharmaceutical development of medicinal products for children from birth to less than 18 years of age. This guideline should be ...

EMA: Draft guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

10.01.2013
This guideline applies to all human and veterinary medicinal products, including investigational medicinal products, and all active substances that are intended for manufacture in premises used ...

EMA: Guideline on the investigation of drug interactions

10.01.2013
The potential for pharmacokinetic interactions between new medicinal products and already marketed drugs should be evaluated. This applies to both effects of the medicinal product on other drugs ...

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