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EUROPE EMEA GUIDANCE DOCUMENTS
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Guideline on stability testing: Stability testing of existing active substances and related finished products
The guideline addresses the information to be submitted in registration applications for existing active substances and related finished products. Full document...
Guideline on the Quality of biological active substances produced by stable transgene expression in higher plants
The guidance offered applies primarily to active substances intended for parenteral administration. For substances intended for non-parenteral administration, although all aspects of the guidance offered may not be applicable, applicants for Marketing Authorisation are reminded that the same general principles apply. Full document...
Guideline oh Virus Safety Evaluation of Biotechnological Investigational Medicinal Products
The guideline covers monoclonal antibodies and recombinant DNA derived IMPs including recombinant subunit vaccines. It does not apply to IMPs that contain recombinant viruses or bacteria (both replicative and non-replicative), or live attenuated or inactivated vaccines. IMPs derived from hybridoma cells grown in vivo are also excluded from the scope of this guideline. Full document...
Guideline on Medicinal Gases, Pharmaceutical Documentation (including recommendation on non-clinical safety requirements for well established medicinal gases)
The aim of the present guideline is to specify the elements relating to the quality of medicinal gases in the context of compiling the pharmaceutical documentation for Module III (Quality) of the dossier. Full document...
Guideline on the clinical and non-clinical evaluation during the consultation procedure on medicinal substances contained in drug-eluting (medicinal substance-eluting) coronary stents
The scope of the present document is restricted to the clinical and non-clinical aspects of the evaluation of ancillary medicinal substances contained in DES coronary stents following by analogy the methods specified in Annex I to Directive 2001/83/EC as amended. Full document...
ICH Topic Q 4B Annex 5 to Note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on disintegration test general chapter
This annex is the result of the Q4B process for Disintegration Test General Chapter.
The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
Full document...
ICH Topic Q 4B Annex 4C to Note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for micrological examination of non-sterile products: acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use
This annex is the result of the Q4B process for Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use.
For each regulatory region the pharmacopoeial text is non-mandatory and is provided for informational purposes only.
The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
Full document...
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