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EMA: Guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins (draft)

07.02.2013
This guideline lays down the non-clinical and clinical requirements for low-molecular-weight-heparin (LMWH)-containing medicinal products claiming to be similar to another one already marketed. ...

EMA: Draft guideline on clinical investigation of medicinal products in the treatment of lipid disorders

07.02.2013
This document is the revised version of the existing guidance note (CHMP/EWP/3020/03) on lipid-modifying agents. The guideline is intended to provide guidance for the evaluation of medicines in ...

EMA: Guidance for the format and content of the final study report of non-interventional post-authorisation safety studies

31.01.2013
From 10 January 2013, marketing authorisation holders have the obligation to comply with the format of the final study report for non-interventional post-authorisation safety studies (PASS), as ...

EMA: Guideline on good pharmacovigilance practices: Module XV – Safety communication

31.01.2013
This Module provides guidance to marketing authorisation holders, competent authorities in Member States and the European Medicines Agency on how to communicate and coordinate safety information ...

GMP: New EMA Guideline on Dedicated Facilities and Exposure Limits for Cleaning Validation

31.01.2013
The draft Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities, published in January had already ...

GMP: FDA publishes Draft Guidance on Design of Medical Devices

31.01.2013
CDRH, the FDA department responsible, inter alia, for the regulation of medical devices, published a new draft guidance in mid-December 2012. The Guidance (\"Design Considerations for Devices ...

Polish Ministry of Health:Regulation of Polish Minister of Health amending regulation concerning composition and labeling of food supplements.

31.01.2013
This Regulation of Polish Minister of Health amends regulation concerning composition and labeling of food supplements. ...

GMP: EMA publishes Reflection paper on Supply Shortages caused by Manufacturing/Good Manufacturing Practice Compliance Problems

24.01.2013
Alarmed by recent medicinal product supply shortages caused by manufacturing/Good Manufacturing Practice Compliance problems EMA has published a Reflection paper that summarises the lessons ...

GMP: New MHRA Q & A Document on the Import of Active Pharmaceutical Ingredients

24.01.2013
In article 46 b of Directive 2011/62/EU it lays down strict rules for the import of active ingredients in the EU. Each import from countries outside of the EU must be accompanied by a written ...

EMA: Concept paper for a guideline on limits for genotoxic impurities

24.01.2013
In the absence of guidance on limits for genotoxic impurities in veterinary medicinal products, the Committee for Medicinal Products for Veterinary Use (CVMP) recommends the development of a ...