12. February 2018
Excipients are crucial ingredients in final drug formulations with potential impacts on product quality, stability, tolerance, release profiles, local distribution and availability, and thus overall efficacy and safety. Recent regulations have increased the requirements for drug manufacturers and excipient suppliers with respect to ensuring the quality and safety of excipients.
08. February 2018
In the highly regulated pharmaceutical industry, manufacturers can’t help but wonder what regulatory authorities like the FDA think of emerging technologies. So what do the global authorities have to say about continuous manufacturing?
17. October 2017
Dry powder inhaler for pulmonary drug delivery: human respiratory system, approved products and therapeutic equivalence guideline
13. October 2017
The European Medicines Agency (EMA) publishes information on excipients for inclusion in the labelling and package leaflet of human medicines.
08. October 2016
International conference: “European Pharmacopoeia: Tackling future challenges of the Quality of Medicines together”, 27-28 September 2016, Tallinn, Estonia The EDQM’s international conference held in Tallinn to mark the publication of the 9th edition of the European Pharmacopoeia (Ph. Eur.) brought together participants from 41 different countries (including Brazil, Canada, India, Japan, South Africa, Taiwan and USA), representing European and international regulatory authorities, the...
27. June 2016
In the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (CPMP/463/00 Rev. 1) Draft report published in support to the Q&A document. For information only
27. June 2016
In the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (CPMP/463/00 Rev. 1) Draft report published in support to the Q&A document. For information only
09. May 2016
The European Medicines Agency (EMA) publishes background documents on excipients for inclusion in the label and package leaflet of human medicines. An excipient is a constituent of a medicine other than the active substance. Following the European Commission decision to revise the Annex of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (CPMP/463/00 Rev. 1), EMA set up the CHMP Excipients Drafting Group (ExcpDG) in 2011. More
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?