13. October 2017

The European Medicines Agency (EMA) publishes information on excipients for inclusion in the labelling and package leaflet of human medicines.

13. April 2016

This guideline provides guidance on the documentation expected for sterile products in the quality dossier for a marketing authorisation application or a variation application for a medicinal product, (called quality dossier throughout the guideline), and the selection of appropriate methods of sterilisation for sterile products. Although, terminal sterilisation using a reference condition of the European Pharmacopoeia (Ph. Eur) is the method of choice whenever possible, this guideline provides...

06. March 2016

VOLUME 3B - Guidelines Medicinal products for human use Safety, environment and information Excipients in the label and package leaflet of medicinal products for human use July 2003 Is this the latest / actual version?

15. December 2015

The new EU guideline 2015/C 95/02 calls pharma companies to run by March 2016 a detailed analysis of the impact and risks expected by the use of the excipients in product development and manufacturing. We discussed the key points of the guideline with representatives of both the suppliers and the pharmaceutical industry. More

07. November 2015

24. June 2015

13. May 2015

Australian regulatory guidelines for complementary medicines (ARGCM) Version 5.2 May 2015 https://www.tga.gov.au/book/types-ingredients-listed-and-registered-complementary-medicines

24. April 2015

On march 21st 2015 the EU published new guidelines on the formalized risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (2015/C 95/02). The manufacturing authorization holder should identify risk presented to quality, safety and function of each excipient. In addition, the excipient manufacturer’s risk profile should be determined using a gap analysis of the required GMP against the activities an capabilities of the...

25. November 2014

By Zachary Brennan+, 25-Nov-2014 The two guidelines offer help to manufacturers looking to use potentially hazardous phthalates as excipients in drugs, as well as those that have shared facilities where multiple drugs are produced. http://www.in-pharmatechnologist.com/Regulatory-Safety/EMA-adopts-guidelines-on-phthalate-excipients-cross-contamination

22. August 2014

Karine Roth, Novartis Pharma AG IPEC Europe Board Member ExcpientFest Europe - June 25, 2014 in Amsterdam http://www.excipientfest.com/europe/pdf/EFE14%20June%2025,%20A2%20Certificate%20of%20Analysis%20Guide%20for%20Pharmaceutical%20Excipients.pdf