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

24.10.2013
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

24.10.2013
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

24.10.2013
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

17.10.2013
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

17.10.2013
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. ...

FDA: Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - Annex 14 Bacterial Endotoxins Test General Chapter

17.10.2013
This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their ...

GMP: Cleaning Validation Requirements in Asia

10.10.2013
The cleaning validation has been one of the main validation topics discussed by the pharmaceutical industry and APIs manufacturers. On Singapore\'s Health Authority site you can find a ...

GMP: FDA publishes revised Guidance for Applicants of Marketing Authorisations for Generics

10.10.2013
The GDUFA (Generic Drug User Fee Act), the new act on fees due for the processing of marketing authorisation applications and the inspection of production sites came into force on 9 July 2012. ...

GMP: EMA gives Clarification to the Variations Guideline in a Q&A Document

10.10.2013
The document has integrated the updates made with regard to amendments to the variations and the provisions of the Variations Regulation (EU) No 712/2012. ...

EMA: Draft guideline on the clinical development of medicinal products for the treatment of HIV infection

03.10.2013
This guideline replaces EMEA/CPMP/EWP/633/02 Rev 2. It provides guidance on the clinical development of direct-acting antiretrovirals for the treatment of HIV infection. ...