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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 ...

EMA: New Guideline on Development of Medicines for Paediatric Use.

18.08.2011
The European Medicines Agency has recently published a draft guideline on pharmaceutical development of medicines for paediatric use. In January 2007 Regulation EC No 1901/2006 (the \"Paediatric ...

EMA: Reflection paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials.

12.08.2011
As IVR/IWR systems are developed to facilitate overall drug management and expanded to assist with dose titration, unblinding and expiry date update, the intent of the paper is to provide guidance ...

FDA: E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions.

12.08.2011
The guidance describes recommendations regarding context, structure and format of regulatory submissions for qualification of genomic biomarkers (as defined in ICH E15). Qualification is a ...

HMA: Requirements on Electronic Submissions (NeeS and eCTD) and Paper Documentation for New Applications within MRP, DCP or National Procedures.

12.08.2011
This document describes the documentation requested by each National Competent Authority for new applications for approval for Marketing Authorisation. ...

HMA: Contact Points for Advice on Mutual Recognition and Decentralised Procedures.

12.08.2011
The list is provided to assist pharmaceutical companies identifying a contact point for advice on the Mutual Recognition or Decentralised Procedures in each Member State. The persons listed should ...

HMA: Procedural Advice on Repeat-Use.

12.08.2011
This document describes the procedure to be adopted for “Repeat Use”. ...

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