News
EMA: Draft qualification opinion total kidney volume (TKV) as a prognostic biomarker for use in clinical trials evaluating patients with autosomal dominant polycystic kidney disease (ADPKD)
06.08.2015
The Critical Path Institute’s Polycystic Kidney Disease Outcome Consortium (PKDOC) intends to qualify Total Kidney Volume (TKV) as a prognostic biomarker (i.e. predictive for the outcome with
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EMA: Concept paper on the need for a single note for guidance on the chemistry of active substances
06.08.2015
This concept paper addresses the need to update and revise the guidance available on the chemistry of the active substance (new and existing active substances). There are currently two approved
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EMA: Concept paper on the revision of the guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant granulocyte-colony stimulating factor
06.08.2015
The current guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor (G-CSF) provides recommendations for the non-clinical and clinical development of
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FDA: Analytical Procedures and Methods Validation for Drugs and Biologics
06.08.2015
This guidance supersedes the draft of the same name that published on February 19, 2014 (79 FR 9467) and replaces the 2000 draft guidance for industry on Analytical Procedures and Methods
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FDA: Request for Quality Metrics Guidance for Industry
06.08.2015
Quality metrics are used throughout the pharmaceutical industry to monitor quality control systems and processes and drive continuous improvement efforts in drug manufacturing. These metrics can
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GMP: Indian and Chinese API Manufacturers in the Focus of European Authorities
06.08.2015
The EudraGMP database was originally launched in April 2007 and is used to exchange information on compliance with the Good Manufacturing Practices (GMP) between the relevant regulatory
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EMA: Stimulating the development of medicines for children
23.07.2015
EMA’s revision of class waiver list expected to push the exploration of many more medicines for use in children
The European Medicines Agency’s Paediatric Committee (PDCO) has revised the
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EMA: Draft guideline on manufacture of the finished dosage form
23.07.2015
This guideline replaces the note for guidance on the manufacture of the finished dosage form (CPMP/QWP/486/95). The note for guidance has been updated to reflect changes to the format and content
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EMA: Draft asenapine sublingual tablets 5 and 10 mg product-specific bioequivalence guidance
23.07.2015
The European Medicines Agency has decided to routinely publish product-specific bioequivalence guidance for a more consistent approach to the assessment of marketing authorisation applications for
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MHRA: Fit for purpose MHRA can lead the way for global regulatory reforms
23.07.2015
The government agency that regulates medicines and medical devices to ensure their quality, safety and efficacy can place the UK at the forefront of a global drive to improve public health,
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