News
GMP: Packaging: Pharmeuropa Draft Chapters regarding PVC
11.05.2017
A draft of Ph. Eur. chapter 3.1.13. Plastic additives has been published for comment in Pharmeuropa 29.2. The chapter has been revised following the identification of
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EMA: Regulatory cooperation to improve global health
23.03.2017
EMA experts meet with African regulators to discuss opportunities for collaboration.
How to improve the availability of high quality, safe and effective medicines to patients in countries
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EMA: Promoting high-quality clinical research in children through strengthened international collaboration
10.02.2017
The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) will hold its ninth annual workshop on 16 May 2017 in London, UK. The aim of the workshop, that will take
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Contract Manufacturing Arrangements for Drugs: Quality Agreements
07.12.2016
This guidance describes FDA’s current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current
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Procedural advice on the certification of quality and non-clinical data for small and medium sized enterprises developing advanced therapy medicinal products
07.12.2016
Article 18 of Regulation (EC) No 1394/20071 provides that Small and Medium-sized Enterprises (SMEs) developing an Advanced Therapy Medicinal Product (ATMP) may submit to the European Medicines
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RAPS: FDA Warns Teva’s Banned Hungary Manufacturing Facility
17.11.2016
The US Food and Drug Administration (FDA) has warned Teva’s Gödöllő, Hungary-based manufacturing site, citing deficiencies in manufacturing operations and laboratory controls, as
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RAPS: FDA Warns Four Foreign Drug Manufacturers
25.10.2016
The US Food and Drug Administration (FDA) on Tuesday released four warning letters sent in September to drug manufacturers from China, the UK, the Netherlands and Switzerland. ...
FDA: Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
20.10.2016
This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing
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GMP: Effect of primary packaging on drug stability of solid dosage forms
08.09.2016
A stimuli article on The Effect of Primary Packaging on the Physical Degradation of Metformin, Lisinopril, and Simvastatin Solid Doses During Patient Use When Stored at Different Temperature and
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GMP: EMA - requirements for quality documentation concerning biological investigational medicinal products
08.09.2016
Already in 2012, the European Commission published a guideline on the quality documentation for IMP in clinical trials. Now on 23 June, the EMA issued a draft \"Guideline on the requirements for
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