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EMA: Standard operating procedure for handling of standard requests for data analysis.

06.09.2011
This document describes the process which is followed by members of the Section for Signal Detection and Data Analysis (P-PV-SDA) in situations when a standard request for data analysis, i.e. ...

Polish Office for Registration: New version of the validation criteria for electronic applications for human medicines.

06.09.2011
Message from the President of the Office for Registration of 30.08.2011 on the revision of the validation criteria for electronic application for human medicines product. ...

FDA: Standards for Clinical Trial Imaging Endpoints.

06.09.2011
The purpose of this guidance is to assist sponsors in the use of endpoints that depend on the results of imaging tests in clinical trials of therapeutic drugs and biological products.2 This ...

EMA: New validation criteria for electronic submissions

29.08.2011
The European Medicines Agency is informing pharmaceutical companies that a new version of the validation criteria for electronic applications for human medicines is coming into effect on Thursday ...

FDA: Documentation (510 k) of Medical Device Modifications

29.08.2011
FDA published a draft on the documentation of medical device modifications. This draft guidance for industry and FDA staff is entitled \"510 (k) Device Modifications: Deciding When to Submit a 510 ...

EUCOMED: The Appropriateness of Evidence and the Learning Curves for Medical Devices in Europe

29.08.2011
Supplement Paper to the Eucomed Position paper on Health Technology Assessment (Siebert et al, 2002) Aiming to Clarify two Important Topics that were already partly Addressed in the First Paper: ...

EMA: PIQ/QRD Pre-Opinion Review of Product Information for Referral Procedures and Article 29 Paediatric Procedures

29.08.2011
The purpose of this document is to ensure a consistent and efficient approach to review the quality of English product information of referral procedures, in particular Articles 30 and 31 of ...

Polish Ministry of Health: Regulation of the Polish Minister of Health amending the regulation on application and notification fees concerning medical devices and the amount of application fee for the issuance of a certificate of free sale.

18.08.2011
Regulation of the Polish Minister of Health of 13.07.2011 amending the regulation on application and notification fees concerning medical devices and the amount of application fee for the issuance ...

HMA: Questions and Answers on Applications for MA.

18.08.2011
Question & Answer on how to change the name of a medicinal product prior to granting a marketing authorisation. ...

HMA: Best Practice Guide on the Assessment Report for Mutual Recognition and Decentralised Procedures.

18.08.2011
Art 28 of Dir 2001/83 EG provides for an assessment report (AR) which describes the assessment of the medicinal product and states the reasons for the conclusions. The purpose of this guideline is ...