News
GMP: Requirements for Risk Analyses in the Regulatory Submission Dossier: EMA\'s and FDA\'s Recommendations
05.03.2015
The EMA has published a new question & answer-(Q&A) paper together with the FDA at the end of 2014. This document answers questions on detailed requirements in connection with the documents
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GMP: Supply Chain: A Series of new Regulations in Force
05.03.2015
The new EU Directive 2011/62/EU and its delegated acts keep on changing the pharmaceutical supply chain. The directive introduced numerous Delegated Acts with different time schedules and had some
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GMP: GMP Data Integrity: New MHRA Guideline
05.03.2015
The MHRA announced in January 2014 that the pharmaceutical industry is expected to review data integrity within the frame of self inspections.
Now, a Guideline of the MHRA on data integrity was
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URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of February 10, 2015 concerning reporting adverse reactions to medicinal products
26.02.2015
This document is an information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of February 10, 2015 concerning reporting adverse reactions
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GMP: EU GMP Annex 1: EMA plans the Revision of the Sterile Guide
26.02.2015
At the beginning of February 2015, the European Medicines Agency (EMA) published a Concept Paper on the revision of Annex 1. Annex 1 of the EU GMP Guide is the Guideline for Europe which describes
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GMP: EU issues new Version of GMP Guide Chapters 3 and 5
26.02.2015
The EU has re-published the recently revised Chapter 3 and Chapter 5 and has made modifications regarding the transition period for the introduction of toxicological evaluations of products in
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FDA: Complicated Intra-Abdominal Infections: Developing Drugs for Treatment, Guidance for Industry
26.02.2015
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated intra-abdominal infections (cIAIs).2 Specifically, this guidance addresses
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HMA: PSUR Work Sharing and Synchronisation Project
26.02.2015
The PSUR work sharing and synchronisation project was initiated in 2002 under the auspices of the HMA and the European Risk Management Strategy Facilitation Group (ERMS FG). The concept of the
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RAPS: FDA Releases Long-Awaited Policies on Regulation of Pharmaceutical Compounders
26.02.2015
The US Food and Drug Administration (FDA) has announced the release of four guidance documents intended to help increase regulatory oversight of the pharmaceutical compounding industry. The
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EMA: Concept paper on the revision of annex 1 of the guidelines on good manufacturing practice – manufacture of sterile medicinal products
19.02.2015
This concept paper addresses the need to update annex 1 (manufacture of sterile medicinal products) of the good manufacturing practice (GMP) guide. Annex 1 is common to the Member States of the
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