GMP: Transitional Regulations for the New Pharmacovigilance Package: Commission\'s Q&A Document provides Clarity

Several provisions for pharmacovigilance have been newly defined among others with Regulation (EU) No 1235/2010 and Directive 2010/84/EU from 2010. Marketing authorisation holders are now ...

GMP: FDA\'s new web-based Training explains FDA Drug Regulatory Work

A new tool has been developed: the \"CDER World\", containing free e-learning modules with information about how CDER works. The respective modules deliver information based on the CDER ...

GMP: Regulatory Monitoring of API Manufacturers - FDA, TGA, EMA and EDQM express Common Objectives for Inspections Collaboration

On 6 March 2012, the EMA published a paper entitled \"Programme to rationalise international GMP inspections of active pharmaceutical ingredient/active substances manufacturers - Terms of ...

EMA: Concept paper on the need for revision of the guideline on excipients in the label and package leaflet of medicinal products for human use (CPMP/463/00)

The current guideline on Excipients in the Label and Package Leaflet of Medicinal Products for Human Use (CPMP/463/00) contains warning statements relating to the presence of certain excipients in ...

GMP: FDA - New draft guidances for Biosimilars

On 9 February the US Food and Drug Administration published three draft guidance documents on the development of biosimilar products. The intention of these documents is to meet the demands of the ...

GMP: EMA Reflection Paper on Sourcing Biological Starting Materials

After the FDA has recently published a draft Guidance on Monitoring Crude Heparin for Quality, the European Medicines Agency EMA has now drafted a Reflection Paper on the use of starting materials ...

EMA: Reflection paper on the use of starting materials and intermediates collected from different sources in the manufacturing of biological medicinal products

In the European pharmaceutical legislation, requirements are outlined for particulars and documents that should accompany an application for marketing authorisation of a biological medicinal product. ...

EMA: Reflection paper on the necessity of initiatives to stimulate the conduct of clinical studies with herbal medicinal products in the paediatric population

The aim of this document is to highlight the lack of clinical studies on the majority of herbal medicinal products in children and the need for initiatives to stimulate the conduct of clinical ...

EMA: Concept paper on the need to revise the points to consider on adjustment for baseline covariates

The Committee for Medicinal Products for Human Use points to consider on adjustment for baseline covariates came into operation in 2003. Since then, they have been widely used by both industry and ...

EMA: Reflection paper on risk management plans for centrally authorised veterinary medicinal products

The current legislation foresees that the applicant may need to develop and describe in detail a risk management system for inclusion in the application before a marketing authorisation can be ...

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