EN PL

News

EMEA: Community herbal monograph on Orthosiphonis staminei folium

07.08.2009
Community herbal monograph on Orthosiphonis staminei folium Orthosiphon stamineus Benth. (java tea leaf) - Draft Community herbal monograph ...

EMEA: Community herbal monograph on Rosmarini aetheroleum

07.08.2009
Community herbal monograph on Rosmarini aetheroleum Rosmarinus officinalis L. (rosemary oil) - Draft Community herbal monograph ...

EMEA: Community herbal monograph on Rosmarini folium

07.08.2009
Community herbal monograph on Rosmarini folium Rosmarinus officinalis L. (rosemary leaf) - Draft Community herbal monograph ...

EMEA: Concept paper on the Need to update the Note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders (CPMP/EWP/3020/03) and the Note for guidance on the clinical investigation on medicinal products in the tre

07.08.2009
Current CHMP recommendations for the clinical development of lipid lowering and blood pressure (BP) lowering agents accept the possibility of drug registration for the so called biological ...

MHRA: Parallel import licences \"two strikes and out initiative\" - application to leaflet variations

07.08.2009
The \"two strikes and out initiative” will now be applied to leaflet variations with the sanction for inadequate response being the suspension of the parallel import licence until the required ...

FDA: Pharmaceutical Components at Risk for Melamine Contamination

07.08.2009
This guidance provides recommendations that will help pharmaceutical manufacturers of finished products, repackers, other suppliers, and pharmacists who engage in drug compounding better control ...

EMEA: Procedural Advice on the certification of quality and non-clinical data for small and medium-sized enterprises developing Advanced Therapy Medicinal Products

05.08.2009
This document gives guidance and describes the procedures, timelines and practical steps to be followed by the applicants and the EMEA for the submission, evaluation of a certification application ...

EMEA: Scientific Guideline on the minimum quality and non-clinical data for certification of Advanced Therapy Medicinal Products

05.08.2009
This guideline addresses the scientific content of an application for certification of quality and non-clinical data, and in particular intends to define the minimum data content for the ...

EMEA: Questions & Answers: Positions on specific questions addressed to the EWP therapeutic subgroup on Pharmacokinetics

05.08.2009
In the context of assessment procedures, the Therapeutic Subgroup on Pharmacokinetics of the Efficacy Working Party (EWP-PK subgroup) is occasionally consulted by the CHMP or, following CHMP’s ...

EMEA: Guideline on Clinical evaluation of diagnostic agents

05.08.2009
The revision of the points to consider on diagnostic agents was decided in order to reflect better the necessary steps in development of diagnostic agents as well as to define the assessment of ...