News
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-
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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)
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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
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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
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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
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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
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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
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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
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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
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FDA: Incorporation of Physical- Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting
13.10.2011
This document is intended to provide guidance to pharmaceutical manufacturers who want to use physical-chemical identifiers (PCIDs) in solid oral dosage forms (SODFs). A PCID is a substance or
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