Chinese authorities pointed out a new roadmap on the quality of pharmaceutical excipients. The representatives of the Chinese Pharmacopoeia have talk about that last September 18th, during a workshop organised by Edqm.
In the last years, China has been committed to adapt production and quality standards to those typical of Western countries.
New edition contents on pharmaceutical excipients
The new system gives much more consideration to the role played by both the excipients and the packaging materials in the production processes of bulk preparations and finished products. In particular, the 2020 edition of the Chinese Pharmacopoeia will introduce a risk management system for the excipients that will cover the entire process, from raw materials and active ingredients to final products. Other news announced during the workshop will cover technical requirements, packaging and storage.
The Strasbourg meeting also provided an opportunity to take stock of the two Pharmacopoeias on other topics of common interest, such as chemicals and traditional Chinese medicine, or China’s participation in international initiatives such as International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Closer collaborations between the Pharmacopoeias
The workshop follows the signing of a Memoranda of Understanding between Edqm and the Chinese Pharmacopoeia aimed at improving collaboration on the safety and quality of medicines both in China and in Europe. The representatives of the Chinese Pharmacopoeia also intervened in 2016 at the workshop organized by Edqm, presenting at that time the structure of the Commission and the principles underlying the compilation of the Asian giant’s Pharmacopoeia (find here the slides of the intervention).
“The quality of medicines depends not only on the active ingredients, but also on the performance of the excipients”, said the EDQM manager, Susanne Keitel, in opening the works. The Strasbourgo organization which takes care of the European Pharmacopoeia thus intended to facilitate the exchange of regulatory aspects between the various authorities and producers, a fundamental element for ensuring the quality of production within a global perspective.