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EC: EudraLex - Volume 2 - Pharmaceutical Legislation Notice to applicants and regulatory guidelines medicinal products for human use

29.05.2014
Volume 2 of the publications \"The rules governing medicinal products in the European Union\" contains a list of regulatory guidelines related to procedural and regulatory requirements such as ...

RAPS: Six New FDA Regulations to be Introduced in 2014, Including Major Change in IND Reporting

29.05.2014
The US Food and Drug Administration (FDA) has released an updated list of regulations it is planning to seek in 2014, known as its \"Unified Agenda,\" outlining six new rules it says it intends to ...

EMA: European Medicines Agency welcomes publication of the Clinical Trials Regulation

29.05.2014
The European Medicines Agency (EMA) welcomes the publication of the Clinical Trials Regulation in the Official Journal of the European Union (EU). This legislation will open up a new era for the ...

EMA: Draft concept paper on the need for revision of the guideline on the clinical investigation of plasma-derived fibrin sealant / haemostatic products

29.05.2014
The currently approved ‘guideline on the clinical investigation of plasma-derived fibrin sealant / haemostatic products’ came into operation in January 2005. Since then, new fibrin sealant ...

EMA: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)

22.05.2014
This guidance document addresses a number of questions which users of the centralised procedure may have. It provides an overview of the European Medicines Agency’s position on issues, which are ...

GMP: WHO publishes Draft on Process Validation

22.05.2014
WHO published a proposal for a revision of appendix 7 (non-sterile process validation) as a supplementary to the Guidelines on Good Manufacturing Practices. The reason given for the revision is ...

GMP: Validation - Revision of Annex 15: Industry\'s \"problems\" - Results of an ECA Industry Survey

22.05.2014
The European Compliance Academy (ECA) has carried out a survey to determine how industry assesses these possible changes and the uncertainties that exist concerning the revision draft. ...

Polish Ministry of Health: Announcement concerning using drugs including imatinib

22.05.2014
This document is an announcement of Polish Ministry of Health concerning using drugs that include imatinib. ...

EMA: European Medicines Agency and US Food and Drug Administration release joint proposal to facilitate clinical investigation of new medicines for Gaucher disease in children

15.05.2014
The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have released a draft joint proposal to facilitate the clinical investigation of new medicines for the ...

EMA: Questions and answers on the withdrawal of the guideline on pharmacokinetics and metabolic studies in the safety evaluation of new medicinal products in animals

15.05.2014
The current guideline on pharmacokinetics and metabolic studies in the safety evaluation of new medicinal products in animals (3BS11A) contains concise statements on the type of animal ...