Aktualności
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
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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
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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
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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
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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
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EMEA: Overview of comments
10.06.2009
Overview of comments received on the draft guideline on the specification limits for residues of metal catalysts ...
EMEA: Overview of comments
10.06.2009
Overview of comments received on the draft guideline on the carcinogenicity evaluation of medicinal products for the treatment of HIV infection ...
EMEA: Overview of comments
10.06.2009
Overview of comments received on the draft guideline on the need for non-clinical testing in juvenile animals on human pharmaceuticals for paediatric indications ...
