China and Taiwan closer to mutual recognition of clinical trial data
Two sides have reached a concrete consensus on clinical trial data recognition
Mainland China and Taiwan are slowly harmonising regulations for clinical trials of drugs, recognition of clinical data and drug inspection.
Following a visit in September by Taiwan’s vice health minister Ming-Neng Shiu to officials in China, Taiwan announced that they had reached a ‘concrete consensus’ on clinical trial data recognition. This follows a cross-straits agreement on medical and health cooperation in 2010.
'Things have been progressing slowly, as one would expect in any matter involving Taiwan and China “recognising” anything from each other,' David Silver, president of BiotechEast, a Taipei-based consultancy for the life science industry, told Manufacturing Chemist.
The two sides discussed recognition of clinical data and data for drug inspection to simplify screening procedures and eliminate double testing, said Wu Mei-hung, deputy minister of Taiwan’s Mainland Affairs Council.
But despite the progress, Silver said that 'no one knows for sure if this is just platitudes until a real case has been completed'.