MHRA: Marketing authorisations: Types of application

There are several alternative procedures to choose from depending on which countries the product is going to marketed in and the type of medicine. ...

GMP: FDA publishes new Guidance on Validation of Analytical Methods

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

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

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

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

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FDA: Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics - Draft guidance

This revised draft guidance complements the International Conference on Harmonisation (ICH) guidance Q2(R1) Validation of Analytical Procedures: Text and Methodology (Q2(R1)) for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

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

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FDA: Draft guidance: Analgesic Indications: Developing Drug and Biological Products

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 ...

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