EMA: Draft concept paper on need for revision of the guideline on medicinal products for the treatment of Alzheimer\'s disease and other dementias

The proposed guideline will replace ‘Guideline on medicinal products for the treatment of Alzheimer’s disease and other dementias’ (CPMP/EWP/553/95 Rev. 1) ...

EMA: European Medicines Agency explores ways to further involve patients in the benefit-risk assessment of medicines

The European Medicines Agency has published a report of the workshop held on 26 September 2013 to discuss further development of patient involvement in the evaluation of medicines, in particular ...

GMP: New Q&A Document of the CMDh gives Answers to Essential Questions on the ASMF Procedure

The Co-ordination Group of Mutual Recognition and Decentralised Procedures (CMDh) has published a Questions & Answers document regarding the Active Substance Master File (ASMF) procedure. In this ...

GMP: New USP Draft on Plastic Materials

The current revision of General Chapter \"Plastic Materials of Construction\" should demonstrate when materials are considered as well-characterised. ...

EMA: Draft reflection paper on the risk of antimicrobial resistance transfer from companion animals

Antimicrobials are important tools for the therapy of infectious bacterial diseases in companion animals. Loss of efficacy of available antimicrobial substances can seriously compromise animal ...

EMA: Draft reflection paper on injection-site residues: considerations for risk assessment and residue surveillance (revision 1)

Residues in injection-site muscle for some products tend to be dramatically higher than residues in non-injection-site muscle (as well as in fat, liver and kidney). The result is that a single ...

EMA: Draft guideline on the conduct of efficacy studies for intramammary products for use in cattle

This revised guideline is intended to provide guidance on the conduct of efficacy studies and their evaluation for veterinary medicinal products that are administered via the teat canal to cattle. ...

EMA: Concept paper on the revision of the note for guidance on the approach towards harmonisation of withdrawal periods

The Committee for Medicinal Products for Veterinary Use (CVMP) note for guidance: approach towards harmonisation of withdrawal periods was published in 1996. While the approach recommended for ...

FDA: Draft guideline: Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors

The purpose of this guidance is to help prescription drug and biologic product manufacturers minimize medication errors associated with their products. This guidance focuses on safety aspects of ...

GMP: The ECA and the PQG publish two draft chapters on GDP interpretation

The European Compliance Academy (ECA) and the Pharmaceutical Quality Group (PQG) announce the availability of two draft chapters on the interpretation of the new EU GDP Guideline. ...

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