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EMA: Concept paper on the development of toxicological guidance for use in risk identification in the manufacture of different medicinal products in shared facilities

02.11.2011
The Safety Working Party recommends drafting new guidance on toxicological assessment to be used in the risk identification stage of the Quality Risk Management process in determining whether a ...

GMP: FDA publishes List of Guidance Documents for Medical Devices

02.11.2011
The FDA published a list in the Federal Register presenting documents regarding the regulation of medical devices which are to be considered for development in the fiscal year 2012 (October 2011- ...

FDA: Q8, Q9, and Q10 Questions and Answers

02.11.2011
Since the Q8, Q9, and Q10 guidances were made final, experiences implementing the guidances in the ICH regions have given rise to requests for clarification. This question and answer (Q&A) ...

EMA: Concept paper on the need for revision of the position paper on indications for veterinary vaccines

02.11.2011
The revised position paper on indications for veterinary vaccine (EMEA/CVMP/042/97-Rev.1-FINAL) was adopted by the CVMP in June 2003. This paper presents the standard statements that should be ...

EMA: ICH guideline E2B (R3) Electronic transmission of individual case safety reports (ICSRs) - implementation guide - data elements and message specification

02.11.2011
This document is a guide for implementing ICH1 requirements for the electronic transmission of Individual Case Safety Reports (ICSRs) according to the ICH E2B(R3) message standard. This ...

GMP: FDA strives for more Transparency regarding GMP Compliance and Enforcement Data

20.10.2011
The U.S Food and Drug Administration (FDA) released 8 new draft proposals in a report titled \"Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to Increase ...

GMP: New Document about Duplicate Marketing Authorisation Applications

20.10.2011
According to Article 82 of the EU Regulation No 726/2004 \"only one authorisation may be granted to an applicant for a specific medicinal product\". In exceptional cases though, the same applicant ...

EMA: Guidance on centrally authorised products requiring a notification of a change for update of annexes

20.10.2011
EMA communicated to all Parallel Distributors that it is not required to inform the EMA on changes to the labelling or leaflet related to any update of the annexes, except for those when the EMA ...

EMA: Concept paper for a guideline on the quality of porcine trypsin used in the manufacture of human biological medicinal products

13.10.2011
Porcine trypsin is a common reagent used during the manufacture of biological medicinal products for the detachment of cells from the culture vessel for their passage. At manufacture of some ...

FDA: Warnings and Precautions, Contraindications, and Boxed Warning Section of Labeling for Human Prescription Drug and Biological

13.10.2011
This guidance is intended to assist applicants and reviewers in drafting the “Warnings and Precautions, Contraindications, and Boxed Warning” sections of labeling for human prescription drug ...