EMA: Policy on veterinary medicines for minor use, minor species / limited market revised

The European Medicines Agency has revised the operation of its minor-use-minor-species (MUMS) / limited-market policy for veterinary medicines to direct its assistance to those medicines most ...

EMA: Guideline on bioanalytical method validation

This guideline defines key elements necessary for the validation of bioanalytical methods. The guideline focuses on the validation of the bioanalytical methods generating quantitative ...

EMA: Guidelines on good pharmacovigilance practices: Introductory cover note, last updated with revision 1 of module III on pharmacovigilance inspections and of module VI on the management and reporting of adverse reactions reports

This new guidance on good pharmacovigilance practices (GVP) is organised into two types of chapters, namely Modules on pharmacovigilance processes and Product or Population-Specific Considerations. ...

EMA: Guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products

This Module of GVP addresses the legal requirements detailed in Title IX of Directive 2001/83/EC [DIR] and chapter 3 of Regulation (EC) No726/2004 [REG], which are applicable to competent ...

EMA: Guideline on good pharmacovigilance practices: Module III – Pharmacovigilance inspections

This Module contains guidance on the planning, conduct, reporting and follow-up of pharmacovigilance inspections in the EU and outlines the role of the different parties in volved. General ...

FDA: Q4B - Annex 6 Uniformity of Dosage Units General Chapte

This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their ...

GMP: Complaints and Recalls: new EU-GMP Chapter 8 published

The European Commission has published the final Chapter 8 of the EU Guidelines for GMP (Complaints, Quality Defects and Product Recalls). The chapter has been revised completely. ...

EMA: New legislation for veterinary medicines

European Medicines Agency welcomes European Commission proposal to increase availability of medicines across Europe. New rules have been proposed by the European Commission to improve the health ...

EMA: Note for guidance on the format and content of the annual report on the state of development of an orphan medicinal product

Article 5 (10) of Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on Orphan Medicinal Products requires sponsors to submit annual reports on the state ...

GMP: Current FDA\'s Warning Letters on IT Topics - Part 2: Finished Medicinal Products and APIs

In a first stage of escalation - when serious GMP deviations are identified during inspections, or in case of insufficient corrective measures - the FDA issues a Warning Letter to the companies ...

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