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EMA: Procedure for orphan-medicinal-product designation: Guidance for sponsors.

16.05.2013
This Regulation lays down a Community procedure for the designation of medicinal products as orphan medicinal products and provides incentives for the development and placing on the market of ...

FDA: Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data

16.05.2013
This guidance describes best practices pertaining to conducting and reporting on pharmacoepidemiologic safety studies that use electronic healthcare data, which include administrative claims data ...

EMA: Draft guideline on similar biological medicinal products

09.05.2013
This Guideline outlines the general principles to be applied for similar biological medicinal products (also known as biosimilars) as referred to in Section 4, Part II, Annex I to Directive ...

EMA: Draft reflection paper on the use of methyl- and propylparaben as excipients in human medicinal products for oral use

09.05.2013
The European Commission has decided to revise the \'Guideline on excipients in the label and package leaflet of medicinal products for human use (CPMP/463/00 Rev.1)\'. A concept paper on the need ...

EMA: Draft guideline on the use of phthalates as excipients in human medicinal products

09.05.2013
Literature data in animals show that certain phthalates are associated with effects on reproduction and development in relation to their hormonal (anti-androgenic) properties. Currently available ...

EMA: Guideline on the acceptability of names for veterinary medicinal products processed through the centralised procedure

09.05.2013
A Community marketing authorisation is valid throughout the European Union and the invented name of the medicinal product is an integral part of the authorisation.The centralised procedure ...

GMP: EMA publishes Updated Procedural Advice for Centralised Marketing Authorisations

09.05.2013
The European Medicinal Agency (EMA) has recently published a revised version of its documents on procedural advice for centralised marketing authorisations and for generic products. ...

GMP: New FDA Guidance for the Prevention of Cross Contamination of Beta-Lactam Antibiotics

09.05.2013
This guidance describes the importance of implementing manufacturing controls to prevent cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients (APIs) with ...

EMA: Concept paper on extrapolation of efficacy and safety in medicine development

25.04.2013
The concept paper is intended to discuss the need and possibility to develop a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine ...

EMA: Concept paper on assessing the toxicological risk to humans and the environment of veterinary pharmaceuticals in groundwater

25.04.2013
This intended guideline should provide further technical support to the implementation of the VICH 19 guidelines GL6 and GL38 on the environmental risk assessment (ERA) of veterinary medicinal ...