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GMP: Revised EU Guideline on Good Distribution Practice with major Changes

12.08.2011
The guideline was revised to take into account advancements of practices for an appropriate storage and distribution of medicinal products in the European Union. Moreover, it should take into ...

EMA: Risk Based Quality Management in Clinical Trials.

09.08.2011
The purpose of this reflection paper is to facilitate the development of a more systematic, prioritised, risk-based approach to quality management of clinical trials, to support the principles of ...

GMP: FDA proposes Changes in Sterility Testing of Biological Products.

09.08.2011
The proposed rule is intended to provide manufacturers of biological products with greater flexibility and to encourage the use of the most appropriate and state-of-the-art test methods for ...

EMA: New EMA Draft Guideline on Stability Data regarding Applications for Variations to a Marketing Authorisation.

09.08.2011
This guideline addresses the requirements in terms of stability testing data which drug manufacturers have to provide when applying variations to a marketing authorisation. Due to the extensive ...

FDA: PET Drugs — Current Good Manufacturing Practice (CGMP)

09.08.2011
This guidance is intended to help small businesses better understand and comply with the regulations issued by FDA concerning current good manufacturing practice (CGMP) for positron emission ...

GMP: New FDA Draft Guidance regarding Design Development of Medical Devices.

09.08.2011
The goal of this guidance is to assist the medical devices industry in performing appropriate human factors testing on medical devices in order to reduce use error and injuries. The FDA hopes that ...

EMA: Concept paper on the revision of the guideline on nonclinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins

02.08.2011
The Guideline on Similar Medicinal Products containing Low-Molecular-Weight Heparins (LMWH) lays down the non-clinical and clinical requirements for the development of LMWH claimed to be similar ...

EMA: Concept paper on the revision of the guideline on nonclinical and clinical development of similar biological medicinal products containing recombinant human insulin

02.08.2011
The current Guidance on Similar Medicinal Products containing Recombinant Human Insulin provides recommendations for the development of recombinant soluble (short-acting) human insulin claimed to ...

EMA: Guideline on bioanalytical method validation

02.08.2011
This guideline defines key elements necessary for the validation of bioanalytical methods. The guideline focuses on the validation of the bioanalytical methods generating quantitative ...

HMA: CMDh Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure

02.08.2011
These Best Practice Guides are intended to facilitate the practical application of the guidance for the handling of Mutual Recognition variations outlined in Notice to Applicants, Volume IIA, ...

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