News
GMP: GCP: EMA Draft Guideline relating to the Trial Master File
11.05.2017
In April 2017 the European Medicines Agency (EMA) has released a draft guideline on good clinical practice compliance in relation to trial master file (paper and/or electronic) for content,
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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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GMP: EU GMP Non-Compliance Report might lead to FDA Import Stop in future
11.05.2017
The new MRA Agreement between the EU and the USA on the mutual recognition of GMP inspections is being discussed in depth. One shouldn't conclude though that the inspection pressure would
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MHRA: MHRA's Interpretation of Cross Contamination & PDEs
23.03.2017
The British inspectorate MHRA has recently published an interpretation that goes into detail on the use of health based exposure limits and explains the cases where EMA's new concept can be
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MHRA: PIC/S statement to European Commission's ATMP GMP Guideline
23.03.2017
During the last months, we reported several times about the current activities of the EMA and European Commission relating to the new GMP Guideline document for Advanced Therapy Medicinal Products
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GMP: EMA issues new Guideline on "Chemistry of Active Substances"
05.01.2017
A medicinal product authorization application requires comprehensive information on origin and quality of an active substance. What information is required was defined in two Guidelines so far:
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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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GMP: FDA´s Drug Safety Draft Guidance regarding REMS
17.11.2016
On September 20, 2016, the Food and Drug Administration (FDA) published a draft guidance for industry on the "Application of Statutory Factors in Determining When a REMS Is Necessary"
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RAPS: EU, Japan to Share More Information on GMP Inspections
25.10.2016
The European Directorate for the Quality of Medicines and Healthcare (EDQM) this week announced a new agreement with Japanese authorities to share more information on the outcome of good
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GMP: MHRA publishes Draft Guidance on "Usability" of Medical Devices
25.10.2016
With its new draft guidance on human factors and usability requirements, the MHRA is giving greater emphasis to design process in the development of medical devices and combination products -
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