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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guidance supersedes the draft of the same name that published on February 19, 2014 (79 FR 9467) and replaces the 2000 draft guidance for industry on Analytical Procedures and Methods ...

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 ...

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 ...

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 ...

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 ...

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 ...

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, ...

GMP: Counterfeit Medicines - A current Case shows that also medium-sized Companies are affected

23.07.2015
The issue of counterfeit medicines is often played down as it only affects the expensive blockbuster products anyway - mostly just products of the large pharmaceutical manufacturers. However, this ...

RAPS: MHRA Wants Input on Single-Use Device Re-Manufacture Guidance

23.07.2015
The Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a survey to gather input on its new draft guidance on the re-manufacturing of single-use devices. ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of July 21, 2015 concerning the publication of the Regulation of the Minister of Health of 8 July 2015 on the method of determinatio

23.07.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of July 21, 2015 concerning the publication of the Regulation ...