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GMP: FDA publishes new Guidance on Validation of Analytical Methods

27.02.2014
This Guideline replaces the Guidance for Industry \"Analytical Procedures and Methods Validation\" from 2000 and - when finalised - should also replace the \"Guidelines for Submitting Samples and ...

EMA: Concept paper on the need for a single note for guidance on the chemistry of active substances

20.02.2014
This concept paper addresses the need to update and revise the guidance available on the chemistry of the active substance. There are currently two approved guidelines on the subject; ...

EC: EU Guidelines for Good Manufacturing Practice- Draft: Annex 15: Qualification and Validation

20.02.2014
This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products. ...

EMA: Draft reflection paper on microbiological aspects of herbal medicinal products and traditional herbal medicinal products

20.02.2014
Directive 2001/83/EC as amended and Directive 2001/82/EC as amended provide definitions for herbal substances, herbal preparations, and herbal medicinal products (HMPs). The basic legislation ...

GMP: Data Integrity - MHRA\'s Current Expectations

20.02.2014
In January 2014, the MHRA declared that as of 2014, pharmaceutical facilities will be expected to verify data integrity in the context of self inspections. ...

FDA: Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics - Draft guidance

20.02.2014
This revised draft guidance complements the International Conference on Harmonisation (ICH) guidance Q2(R1) Validation of Analytical Procedures: Text and Methodology (Q2(R1)) for developing and ...

EMA: New EMA Guidance Qualification of novel Methodologies for Drug Development

13.02.2014
The European Medicines Agency EMA has published the revised Guidance to Applicants \"Qualification of novel methodologies for drug development\". ...

EMA: Regulatory information - EMA clarifies interpretation of new variation classification categories

13.02.2014
The Commission guidelines on variations to marketing authorisations of medicinal products were amended in 2013. The revision of the variations guidelines was principally triggered by the ...

FDA: Draft guidance: Analgesic Indications: Developing Drug and Biological Products

13.02.2014
This guidance focuses on clinical drug development and trial design issues and chemistry, manufacturing, and controls (CMC) concerns that are unique to the study of acute, chronic, and ...

EMA: Draft guideline on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products

06.02.2014
This guideline addresses the influence of pharmacogenomics on pharmacovigilance activities, including considerations on how to evaluate the pharmacovigilance related issues for medicinal products ...

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