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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This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic.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 ...

EMA: Draft guideline on clinical investigation of medicinal products for the treatment of acute heart failure

17.01.2013
The CHMP Note for Guidance on the Clinical Investigation of Medicinal Products for the Treatment of Cardiac Failure (CHMP/EWP/235/95, rev. 1) provides limited regulatory guidance for development ...

EMA: Concept paper on the need for a paediatric addendum to the guideline on clinical investigation of medicinal products for the treatment of acute heart failure

17.01.2013
The CHMP guideline on the clinical investigations of medicinal products for the treatment of Acute Heart Failure (AHF) addresses the development issues in this specific patient population but is ...

MHRA: Guidance on EU Commission Regulation 207/2012 on electronic labelling of medical devices

17.01.2013
This Regulation which comes into force on 1 March 2013 allows manufacturers of certain types of medical devices and accessories to provide electronic instructions for use if they wish and lays ...

EMA: Draft guideline on pharmaceutical development of medicines for paediatric use

10.01.2013
This guideline is intended to provide additional guidance for the pharmaceutical development of medicinal products for children from birth to less than 18 years of age. This guideline should be ...