COMMENTS FROM THE EUROPEAN UNION CONCERNING NOTIFICATION

G/TBT/N/CHN/1169

WORK PROGRAM FOR THE REFORM OF CHEMICAL DRUGS REGISTRATION CATEGORY

The European Union (EU) would like to thank the Chinese authorities for providing the opportunity to comment on the proposed "Work programme for the Reform of Chemical Drug Registration Category" which was notified on 26 February 2016.

The EU takes note of the efforts and intention of the Chinese authorities to improve and modernise the regulatory system in China. The ongoing efforts to reform the Chemical Drug Registration provide further opportunities to develop a robust regulatory framework that is increasingly aligned with international standards.

The EU welcomes the broad objectives of the "Reform of Chemical Drug Registration", in particular, the goals of encouraging innovation and raising the quality, safety and effectiveness of drugs marketed in China. Appropriate implementation of these goals could have tangible benefits for Chinese patients, including faster access to new and innovative therapies. However, the EU would like to raise its concerns in relation to the registration categories of chemical drugs introduced by the Reform: