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EMA: Scientific guideline: Guideline on the minimum quality and non-clinical data for certification of advanced therapy medicinal products

15.11.2010
This guideline addresses the scientific content of an application for certification of quality and nonclinical data, and in particular intends to define the minimum data content for the ...

Polish Ministry of Health: Regulation concerning classification of medical devices

09.11.2010
The new regulation concerns the methods, principles and special rules of categorization of medical devices. ...

HMA: Requirements on Electronic submissions (NeeS and eCTD) and paper documentation for New Applications within MRP, DCP or National procedures

09.11.2010
Most NCAs are now ready to receive electronic-only applications and applicants are therefore strongly encouraged to submit in electronic format (eCTD or NeeS) to these NCAs, even if many still ...

EMA: Scientific guideline: Guideline on repeated dose toxicity

09.11.2010
This guideline concerns the conduct of repeated dose toxicity studies of active substances intended for human use. For certain types of substances, such as biotechnology-derived compounds, ...

EMA: Regulatory and procedural guideline: Practical information for sponsors during the early phase of an orphan drug application

09.11.2010
This is a short list of practical issues and information for sponsors planning to submit an application for designation of a medicine as an orphan medicinal product. It does not replace the legal ...

Main Pharmaceutical Inspectorate: The Main Inspector statement related to impersonate Main Pharmaceutical Inspectorate employer.

26.10.2010
The Main Inspector statement related to impersonate Main Pharmaceutical Inspectorate employer. ...

EMA: Regulatory and procedural guideline: Implementation plan for the \'Note for guidance - EudraVigilance Human – Processing of safety messages and individual case safety reports (ICSRs) (EMEA/H/20665/04/Final Rev. 2)

26.10.2010
The scope of the revised note for guidance is to improve the quality and consistency of ICSRs reported electronically. This has been achieved by strengthening of the validation processes of ICH ...

EMA: Regulatory and procedural guideline: Guideline for the specifications of e-submissions of parallel distribution notification documents

26.10.2010
This Guidance is intended to assist Parallel Distributors with the submission of notifications or notifications of a change for parallel distribution in electronic format to the Agency. It is ...

EMA: Scientific guideline: Questions and answers on the guideline on the limits of genotoxic impurities

26.10.2010
The aim of this question-and-answer document is to provide clarification and harmonisation of the \'Guideline on the limits of genotoxic impurities\' (EMEA/CHMP/QWP/251344/2006), published in 2006. ...

FDA: Qualification Process for Drug Development Tools

26.10.2010
This guidance describes the qualification process for drug development tools (DDTs) intended for potential use, over time, in multiple drug development programs. DDTs include, but are not limited ...