Two INDs or not two INDs? Unanswered questions in China draft MRCT guide
The proposed guidelines (here in Mandarin) set out the China Food and Drug Administration’s (CFDA) position on multi-regional clinical trials (MRCT), which are not covered in existing Drug Registration Rules (DRR) or Good Clinical Practices for Drugs (GCP) regulations.
In addition to opening up all dossiers and sites to CFDA inspection, sponsors must check to see if Chinese patients in the MRCT study are “representative” of the broader population, which may be a tall order in a country with at least 17 distinct ethnic groups.
Sponsors and any contract research organisations (CROs) they work with in China and overseas will also need to make sure that investigators working at different sites perform in a consistent manner.
The draft guidelines – which are open for public comment until the end of December - also state that once an MRCT is completed all data from all study sites must be submitted to the CFDA for review.
Additional INDs?
Although the draft guidelines do provide sponsors attracted by China’s large treatment naïve population and market with some idea of what will be needed to include the country in a multi-regional programme, there are still grey areas.
Lawyer Katherine Wang from Ropes & Gray highlighted one area that lack details, pointing out in a commentary that: “The Guidance does not clarify the ambiguity in the DRR as to how an MRCT should proceed to a new drug application or biologics application the final drug marketing authorization in China.
“Specifically, the Guidance is silent on whether a separate IND application is still required if the MRCT data meets all the substantive requirements to be accepted for the NDA or BLA review in China.”
This is a big unanswered question as – according to the CFDA website – IND reviews in China can take a lot longer than the 30 and 60 day timelines that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) set.
