FDA: Guidance for Industry – Q4B Evaluation and Recommendation of Pharmacopoeial Text for Use in the ICH Regions

This Annex is the result of the Q4B process for Polyacrylamide Gel Electrophoresis General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group. ...

EU Ministry of Health: Better regulation of veterinary pharmaceuticals: how to put in place a simpler legal framework, safeguarding public and animal health while increasing the competitiveness of companies

Within the European Union veterinary medicinal products are regulated by legislation throughout their entire lifetime on the basis of scientific expertise. In order to ensure the quality, safety ...

FDA: Guidance for industry – dosage and administration section of labeling for human prescription drug and biological products

The goal of this guidance is to help ensure that the dosage and administration section contains all the information needed for safe and effective dosing and administration of a drug and the ...

EMA: European Medicines Agency standard operating procedure (SOPs) on: Type IA variations to centralised marketing authorisations (medcines for human use)

The purpose of this SOP is to describe the procedure for handling of Type IA variations to centrally authorized medicinal product for human use. It applies to the Quality of Medicines and Safety ...

EMA: Guideline on the Evaluation of Medicinal Products indicated for treatment of bacterial infections

This guideline considers the microbiological and clinical data required to support indications, dose regimens and durations of therapy for antibacterial agents and the layout and wording of some ...

EMA: Draft guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg)

The purpose of this guideline is to provide applicants and regulators with harmonized guidance for applications for marketing authorization for IVIg. ...

EMA: Updated inventory of herbal substances for assessment

Inventory of herbal substances for assessment – alphabetical order. ...

EMA: Compilation of Community Procedures on Inspections and Exchange of Information

The Compilation of Procedures is a collection of GMP inspection- related procedures and forms agreed by the GMP inspectorates of all the Member States and designed to facilitate administrative ...

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