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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GMP: FDA publishes Draft Guidance on Design of Medical Devices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CDRH, the FDA department responsible, inter alia, for the regulation of medical devices, published a new draft guidance in mid-December 2012.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 ...

EMA: Concept paper for a guideline on antimicrobial-resistance risk assessment

24.01.2013
The Committee for Medicinal Products for Veterinary Use (CVMP) intends to draft a guideline on antimicrobial-resistance risk assessment to be applied for all classes of antimicrobial agents. The ...

FDA: Guidance for Industry Providing Submissions in Electronic Format - Summary Level Clinical Site Data for CDER’s Inspection Planning

24.01.2013
This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and ...

EMA: European Medicines Agency updates guideline on evaluation of anticancer medicines

17.01.2013
The European Medicines Agency has finalised the revision of its guideline on the evaluation of anticancer medicinal products. This revision includes, amongst other topics: the use of biomarkers as ...