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European Commission: Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Chapter 5: Production.

23.11.2010
Reasons for changes: changes have been proposed to sections 25 and 26 on the qualification of suppliers of starting material in order to reflect the legal obligation of ...

EMA: Scientific guideline: Reflection paper on stability testing of herbal medicinal products and traditional herbal medicinal products

15.11.2010
This reflection paper addresses the need for specific requirements for establishing the stability of herbal medicinal products (HMPs). The quality, including the stability, of HMPs should be ...

EMA: Questions & answers on quality of herbal medicinal products/traditional herbal medicinal products

15.11.2010
Questions & answers on quality of herbal medicinal products concern topics: Specification & Testing, Contaminants, Manufacturing, Quality of water, Stability. ...

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 ...