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MHRA: Better Regulation of Medicines Initiative (BROMI): Improvements in Detailed Descriptions of Pharmacovigilance System (DDPS) assessments

23.06.2009
A new system for the processing of the Detailed Descriptions of Pharmacovigilance System (DDPS) of Marketing Authorisation Applications (MAAs) has now been introduced. ...

EMEA: Joint scientific report of ECDC, EFSA and EMEA on meticillin resistant Staphylococcus aureus (MRSA) in livestock, companion animals and food

19.06.2009
The information provided represents the overall conclusions and recommendations from the previously mentioned reports The EFSA/BIOHAZ conclusions and recommendations reflect the focus of the ...

European Commission: New regulation on maximum residue limits

19.06.2009
The new Regulation laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation ...

MHRA: Medicines for children: Including the product name when submitting information on paediatric studies in accordance with the Paediatric Regulation

19.06.2009
Since the introduction of the European Paediatric Regulation in 2007, Marketing Authorisation (MA) holders are required to submit paediatric studies completed since the date of entry into force ...

EMEA: Draft guideline on quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines

15.06.2009
The objective of this guideline is to provide recommendations on the quality, non-clinical and clinical studies that should be performed in order to obtain marketing authorisation of a live ...

EMEA: Addition of questions to pre-submission guidance (Q50, 51, 52)

15.06.2009
What is the Community Plasma Master File certification system? What is the Community Vaccine Antigen Master File certification system? What is Eudravigilance? How will it apply to ...

EMEA: Template for the Cover Letter

15.06.2009
Template for the Cover Letter to submit study in accordance with Art. 46 of the Paediatric Regulation. ...

EMEA: Draft Guideline on selection of test materials for genotoxicity testing for traditional herbal medicinal products/herbal medicinal products

15.06.2009
This guideline addresses the selection of materials for genotoxicity testing in support of applications for traditional herbal medicinal products/ herbal medicinal products. This guideline ...

Polish Ministry of Health: The project of Act of the medical devices

10.06.2009
Polish Ministry of Health: The project of Act of the medical devices ...

EMEA: Draft guideline on Epidemiological Data on Blood Transmissible Infections Rev. 1

10.06.2009
The CHMP/BWP assigned to the Epidemiological expert group the task of conducting an extensive critical analysis of the data in the PMF dossiers, and a revision to the guideline is aimed to improve ...