Aktualności
CMDh: CMDh BEST PRACTICE GUIDES FOR THE SUBMISSION AND PROCESSING OF VARIATIONS IN THE MUTUAL RECOGNITION PROCEDURE
11.08.2010
Commission Regulation (EC) No. 1234/2008 is effective 1 January 2010 and replaces 1084/2003/EC. It concerns variations in the Mutual Recognition procedure and Centralised procedure. Since the
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Polish Office for Registration: The statement of the President of the Office for Registration relating to bioequivalence of the generic medicinal products
04.08.2010
The statement of the President of the Office for Registration relating to bioequivalence of the generics with reference to original medicinal products. ...
Polish Ministry of Health: Regulation project relating to application form related to the registration matters (renewals or shortening of registration)
04.08.2010
Regulation project relating to application form related to the registration matters (renewals or shortening of registration) ...
MHRA: Labelling of medicines: Reminder – update to labelling to comply with Article 54(a), 54(e) and 56(a)
04.08.2010
The legislation provided a transitional period for the labelling of medicines which were the subject of a granted marketing authorisation at the time the regulations came into force on 30 October
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MHRA: Maintenance of Active Pharmaceutical Ingredient (API) and other sites named on marketing authorisations
04.08.2010
Marketing and manufacturing authorisation holders are reminded that as all sites named on approved marketing authorisations (MAs) can be used for the activity they have been registered for without
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MHRA: Adverse drug reactions: Update on Anonymised Single Patient Reports (ASPRs): July 2010
04.08.2010
The MHRA has implemented a series of changes to the logic which defines which marketing authorisation holders (MAHs) receive ASPRs/Individual Case Safety Reports (ICSRs). It is expected that these
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FDA: ICH Q3C Maintenance Procedures for the Guidance for Industry Q3C Impurities: Residual Solvents
04.08.2010
Draft Recommendation for the Revision of the Permitted Daily Exposure for Cumene According to the Maintenance Procedures for Q3C Impurities: Residual Solvents ...
FDA: The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application
04.08.2010
This guidance is intended to provide information for those using radioactive drugs for certain research purposes to help determine whether research studies can be conducted under 21 CFR 361.1,
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FDA: Label Comprehension Studies for Nonprescription Drug Products
04.08.2010
The Food and Drug Administration (FDA) sometimes requires sponsors to conduct label comprehension studies that are designed to evaluate proposed nonprescription drug product labeling. This
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EMA: Scientific guideline: Questions & Answers: positions on specific questions addressed to the EWP therapeutic subgroup on pharmacokinetics
04.08.2010
In the context of assessment procedures, the Therapeutic Subgroup on Pharmacokinetics of the
Efficacy Working Party (EWP-PK subgroup) is occasionally consulted by the CHMP or, following
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