The International Pharmaceutical Excipients Council (IPEC) – currently represented by divisions in Europe, the Americas, Japan and China – could see sister organisations open up in Latin America and India in the coming months.
IPEC represents the interests of excipient manufacturers, distributors and users, with a particular focus on the science and regulation of pharmaceutical excipients.
For years there were just three chapters, but IPEC established a Chinese division in July 2008, and this has been working with China’s State Food and Drug Administration (SFDA) to help revise proposed excipient legislation.
IPEC China update
The first project for IPEC China was a complete translation of all the IPEC guidelines into Mandarin, which have now been given to SFDA and will be taken into account as it revisits excipient legislation. It has now moved onto a new project – to help SFDA develop an excipient master file system that is workable for both the regulatory body and industry.
An EMF involves the filing of a dossier with the regulator, which can then be cited by companies wishing to make use of the ingredient ion their medicinal product. At the moment, in China (and also in Europe) filings can only be made as part of the Marketing Authorisation Application.
EMFs can contain both open and closed portions of data, can provide excipient developers with protection for research into novel excipients and also makes it easier for excipient users to make use of new ingredients.
As a matter of course IPEC China will now be involved in global IPEC (formerly TriPEC) meetings, and will also be present at Pharmacopoeial Discussion Group (PDG) meetings.
At the embryonic stage is the potential for an IPEC Brazil and also an IPEC Argentina.
IPEC Europe recently attended a meeting of the Brazilian regulatory authority (ANVISA) at which it was able to present on the topics of excipient Good Manufacturing Practice (GMP).
Subsequently, Brazil has deferred plans to develop regulation on excipient GMP while it watches developments elsewhere around the world, such as progress with the European “certain excipients” proposals and self-regulation approaches such as certification.
IPEC has made contact with Brazilian trade body Sindusfarma, however, and will be working with that group to disseminate information about IPEC guidelines and create a working party that could in time develop into a full-blown IPEC chapter. Similar discussions are underway with a group in Argentina.
The next step after this would be to create an IPEC India, although this is in the very early stages, according to IPEC.
Meanwhile, a meeting in the US in a few weeks will bring all four of the current IPECs together and try to establish some guiding principles for the group as a global organisation.
The intent is to identify the common strategic objectives for excipients manufacturers and users. Further down the line, it is also possible that an umbrella IPEC could be set up to provide a unified voice and forum for all the IPEC chapters around the world.