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EMA: Reflection paper on pharmacovigilance communication concerning veterinary medicinal products - Draft

21.02.2013
The experience gained by regulatory authorities has demonstrated the need and the benefits of streamlining and coordinating the communication process effectively within the European Union (EU) ...

GMP: Regulatory Requirements concerning Quality Assurance of Medical Devices in Japan

21.02.2013
Japan is an interesting market, also for medical devices. But in some parts the country is very different from Europe with regard to culture (writing, requirements concerning the appearance of ...

GMP: FDA publishes List of planned Guidances for Medical Devices

21.02.2013
At the end of 2012 the Center for Devices and Radiological Health (CDRH) published a list with the Guidances planned for the fiscal year 2013 (1 October 2012 to 30 September 2013). The CDRH is the ...

GMP: New Guidance for Recall of IMPs

21.02.2013
The European Commission DG Health & Consumers has published the revised EU-GMP Chapter 8 on Complaints, Quality Defects and Product Recalls. The chapter has been revised completely. Whereas the ...

GMP: EMA issues Concept Paper for Antimicrobial Resistance Risk Assessment Guideline

21.02.2013
Antimicrobial1 resistance (AMR) is an important issue to be addressed in applications for marketing authorisations of veterinary medicinal products (VMP) and related issues regarding animal ...

EC: Guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use - Draft

14.02.2013
These guidelines provide guidance on how to asses and rank the risk presented by the excipient, cover identification on appropriate GMP and assesment and present guidance on how to manage the ...

EC: Guidelines on the principles of good distribution practices for active substances for medicinal products for human use - Draft

14.02.2013
For the purpose of these guidelines, the distribution of active substances for medicinal products for human use (hereafter \'active substances\') is the procuring, import, holding, supplying or ...

GMP: WHO GMP approaching EU-GMP

14.02.2013
The current good manufacturing practices (GMP) for pharmaceutical products of the World Health Organisation (WHO) are going to be updated. WHO\'s GMP main principles are published as Annex 3 in ...

FDA: Draft Guidance for Industry Immunogenicity Assessment for Therapeutic Protein Products

14.02.2013
This draft guidance is intended to assist manufacturers and clinical investigators involved in the development of therapeutic protein products for human use. In this document, FDA outlines and ...

FDA: Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling

07.02.2013
This guidance is intended to assist the pharmaceutical industry and other investigators engaged in new drug development in evaluating how variations in the human genome, specifically DNA sequence ...