Aktualności
EMA: Regulatory and procedural guideline: Concept paper on Storage Conditions during Transport, draft.
23.11.2010
The globalisation of the manufacture of human and veterinary medicinal products has brought both
benefits and a wide range of challenges. This paper is concerned with challenges related to
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EMA: Dossier requirements of the members of the Committee for Medicinal Products for Human Use (CHMP)
23.11.2010
Dossier requirements and personal data of the members of the Committee for Medicinal Products for Human Use (CHMP) ...
EMA: Scientific guideline: Guideline on data to be provided in support of a request to include a substance in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009.
23.11.2010
This guideline contains guidance relating to the data to be provided in support of a request for the CVMP to consider the inclusion of an excipient in the list of substances considered as not
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European Commission: Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Chapter 5: Production.
23.11.2010
Reasons for changes: changes have been proposed to sections 25 and 26 on the qualification
of suppliers of starting material in order to reflect the legal obligation of
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EMA: Scientific guideline: Reflection paper on stability testing of herbal medicinal products and traditional herbal medicinal products
15.11.2010
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
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EMA: Questions & answers on quality of herbal medicinal products/traditional herbal medicinal products
15.11.2010
Questions & answers on quality of herbal medicinal products concern topics: Specification & Testing, Contaminants, Manufacturing, Quality of water, Stability. ...
EMA: Scientific guideline: Guideline on the minimum quality and non-clinical data for certification of advanced therapy medicinal products
15.11.2010
This guideline addresses the scientific content of an application for certification of quality and nonclinical
data, and in particular intends to define the minimum data content for the
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Polish Ministry of Health: Regulation concerning classification of medical devices
09.11.2010
The new regulation concerns the methods, principles and special rules of categorization of medical devices. ...
HMA: Requirements on Electronic submissions (NeeS and eCTD) and paper documentation for New Applications within MRP, DCP or National procedures
09.11.2010
Most NCAs are now ready to receive electronic-only applications and applicants are therefore strongly encouraged to submit in electronic format (eCTD or NeeS) to these NCAs, even if many still
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EMA: Scientific guideline: Guideline on repeated dose toxicity
09.11.2010
This guideline concerns the conduct of repeated dose toxicity studies of active substances intended for
human use. For certain types of substances, such as biotechnology-derived compounds,
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