EMA: Draft guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals

This guideline provides advice in regards to applications for marketing authorisations for antimicrobial veterinary medicinal products on the data required and the methodology to be used for ...

EMA: Draft guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances

This guideline provides recommendations for the design and conduct of pre-clinical and clinical studies to support clinical efficacy for an antimicrobial veterinary medicinal product. Appropriate ...

GMP: Causes for Weight Variations during Tableting

Weight variations of the tablets produced is a relatively common problem of the tableting process. But each tableting process aims at producing tablets with a constant weight. The actual cause for ...

RAPS: EU Task Force to Implement New Drug Identification Standards

The European Medicines Agency (EMA) has announced it is putting together a task force to oversee the implementation of new standards for identifying drugs. The goal of the task force will be to ...

RAPS: FDA Plans to Fund Research on Generic Drug Efficacy, Medical Countermeasures and More

The US Food and Drug Administration (FDA) hopes to obtain private sector help to improve nine areas of regulatory science, including the evaluation of generic drug effectiveness and expedited ways ...

Asia Regulatory Roundup: China Rolls out New Clinical Practice Rules (24 February 2015)

China Food and Drug Administration’s (CFDA) recently introduced draft good clinical practices (GCPs) will clarify the process for outsourcing to contract research organizations (CROs), ...

FDA: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application

This guidance sets forth FDA’s policy regarding the mixing, diluting, and repackaging of certain types of biological products that have been licensed under section 351 of the Public Health ...

EMA: Regulatory information - EMA introduces weekly start dates for the assessment of type II variations from March 2015

The new timetables are expected to increase submission flexibility and streamline assessment of applications. From March 2015, the European Medicines Agency will introduce weekly start dates to ...

EMA: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

This integrated version has been created for printing purposes only. Please refer to the individual question & answers as published in the post-authorisation guidance for access to the hyperlinked ...

RAPS: The Essential Guide to Finding FDA Information on Drugs, Medical Devices and Biotech

Finding regulatory information can be difficult. Maddeningly difficult. Anyone interested in finding information about the US Food and Drug Administration (FDA) needs to have an almost ...

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