Pharmaceutical News
New CFDA regulations help expedite the launch of drugs from Taiwan

Reported by Huang Wen-Chi from Taipei

A major breakthrough in the cross-strait cooperation on healthcare has been achieved.  According to the IBMI, a clear official pathway has been established for drugs licensed in Taiwan to enter the Chinese market.  In the future, Taiwanese biotech companies can use the clinical data generated in Taiwan to apply for marketing authorization in China.  It will cut the lead time by 5-7 years.

The CFDA recently announced a few guidelines regarding the review and approval of certain drugs (including Chinese medicines, natural medicines and biological products) which have already been licensed in Hong Kong, Macao or Taiwan.  According to those guidelines, Taiwanese manufacturers will be able to legally cite the clinical data generated in Taiwan to support their applications of marketing authorization in China.  There is no need to repeat clinical trials in China.

The CFDA’s announcements specify the documents and time required for application review.  The review will be carried out by the evaluation center in China.  So far, the pathway is only applicable to Chinese medicines, natural medicines and biological products.  They have to be already licensed and justified by clinical data.

In spite of President Tsai’s New Southbound Policy, many drug companies in Taiwan still consider the Chinese market most attractive because it is the world’s second largest drug market.  The IBMI started promoting the cross-strait cooperation on healthcare in 2008.  Their efforts led to the “Cross-Strait Cooperation Agreement on Medicine and Public Health Affairs” in 2010.  The CFDA’s announcements were a major breakthrough since the Agreeing was signed.  The clinical data harmonization will underpin the collaboration in the R&D of treatments for diseases common among Chinese ethnic groups.

Drug companies got frustrated with the vague regulations of drug review and approval in China.  As the CFDA brought the regulations into line with international standards, a clear official pathway is now finally established.  It will help Taiwanese manufacturers to launch their products in China.

【2017-08-02/ Economic Daily】