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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 ...

EMA: Draft guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis

15.05.2014
The proposed guideline will replace the guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis (CPMP/EWP/422/04) ...

EMA: European Medicines Agency releases best practice guidance on parallel scientific advice with health-technology-assessment bodies

15.05.2014
The European Medicines Agency (EMA) has published for public consultation best practice guidance for pilot parallel scientific advice procedures involving the EMA and health-technology-assessment ...

GMP: EMA issues Draft Guideline on Process Validation for Biotechnological Products - an Analysis

15.05.2014
The draft on process validation for biotechnologically manufactured active pharmaceutical ingredients describes the required data to be submitted for the marketing authorisation or variation of ...

FDA: Guidance for Industry: Stability Testing of Drug Substances and Products, Questions and Answers

15.05.2014
This guidance provides answers to questions from the public comments we received on the draft guidance for industry on NDAs: Stability Testing of Drug Substances and Products (FDA stability ...