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EMA: Guideline on the clinical investigation of medicinal products for the treatment of attention deficit hyperactivity disorder (ADHD)

11.08.2010
This Guideline is intended to provide guidance on the evaluation of new medicinal products in ADHD with focus on the childhood onset. It is the first guideline written in psychiatry to address a ...

CMDh: CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008

11.08.2010
CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008 ...

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 ...

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 ...

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 ...

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 ...

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, ...