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This guidance provides answers to questions from the public comments we received on the draft guidance for industry on NDAs: Stability Testing of Drug Substances and Products (FDA stability ...

EMA: Draft guideline on non-clinical local tolerance testing of medicinal products

08.05.2014
Local tolerance testing is intended to support human exposure to a medicinal product (both active substance and excipient) at contact sites of the body following clinical use. ...

EMA: Draft guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues (Rev 2)

08.05.2014
This guideline lays down the non-clinical and clinical requirements for recombinant insulin-containing products, including human insulin and insulin analogues (both referred to as insulin), ...