EU trailing as China moves ahead with master file plans
pharmafile | September 28, 2010 | News story | Manufacturing and Production |Â Â API, China, EU, excipientsÂ
There has been progress in China on the development of drug master files for pharmaceutical ingredients and components, highlighting once again a gap in the European Union’s regulatory system.
China’s State Food and Drug Administration (SFDA) has published the draft of the rule implementing a DMF system for active pharmaceutical ingredients, excipients and packaging materials which is open for comment until October 30.
While the document is still a framework to proceed, with much of the detail coming later, China’s progress in this area means that the EU is falling further behind other countries in drawing up a comprehensive DMF system.
The US, Canada, Australia and Japan for example have master file systems that can be applied broadly across a range of components, but the European master file system is restricted only to active pharmaceutical ingredients (APIs). Moreover, in 2004 biological APIs were excluded on the grounds that they were not sufficiently well-defined, so now the system only applies to chemical APIs.
Trade groups such as the European chapter of the International Pharmaceutical Excipients Council (IPEC) have been lobbying hard to get Europe’s master file system extended to include excipients and other elements.
IPEC Europe has developed position papers which indicate the current system is stifling innovation in Europe, delaying the take-up of novel excipients which can enhance medicines by improving shelf-life, stability and efficacy, and blocking harmonisation with other regulatory systems.
At present excipients can only be approved in Europe in the context of a marketing application for a medicinal product and, because there is a perception that use of a novel excipient might add complexity to a marketing application review, drugmakers can sometimes be reluctant to make use of them.
An extension of the European master file system to include them would allow direct communication between the excipient developer and the regulator and overcome this issue, and also give the regulator a much greater level of information on the ingredient.
The lack of a master file system also raises issues of commercial confidentiality.
Elsewhere, a master file for an excipient held by the regulator can remain under wraps but be cited by drugmakers who want to make use the ingredient in a medicinal product. In Europe excipient suppliers currently have to hand over comprehensive dossiers to all customers using their product, raising the risk of commercially-sensitive information getting into the hands of competitors.
One company at the sharp end of this situation is Novozymes Biopharma, which develops and sells novel excipients such as its recombinant albumin product albucult.
A DMF for albucult containing proprietary information on manufacturing processes and safety was recently accepted in the USA, making it easy for US drugmakers to tap into the excipient’s improved biocompatibility, sustainability and batch-to-batch consistency.
“The lack of a master file system for excipients in the EU means we can still bring these new products to our European customers, but the process is made more laborious in terms of documentation,” commented Kate Denton, Novozymes Biopharma’s regulatory affairs manager who also serves on IPEC Europe’s quality and regulatory affairs committee.
“Master files would bring in a standardised and consistent approach to excipient information that would be a benefit to excipient manufacturers, users and regulators alike,” she said.
Meanwhile, in China the DMF system now looks set to be trialled at both the state and provincial level before adoption across the country.
The SFDA has for the moment set no official timeframe for implementing the DMF programme but, with European regulators firmly focused on topics such as falsified medicines, patient information and pharmacovigilance, it will likely be in place some way ahead of any EU initiative in this area.
Phil Taylor
Related Content
Sharp invests $100m in US and EU manufacturing and packaging facilities
Sharp Services, a pharmaceutical packaging and sterile manufacturing specialist, has announced investments totalling $100m across …
Sarclisa recommended for EU approval in newly diagnosed multiple myeloma
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended Sanofi’s …
EU approval granted for rare kidney disease treatment
The EU has granted marketing authorisation (MA) for Filspari – CSL Vifor and Travere Therapeutics’ …
