On 30 September 2019, the Chinese National Medical Products Administration (the NMPA) published three sets of draft regulations seeking public comment. They are the Draft Drug Registration Regulations, the Draft Manufacturing Regulations and the Draft Drug Distribution Regulations. The Ministry of Justice further updated these Draft Regulations on 15 October 2019 and is seeking public comments on these further amended Draft Regulations. The new commenting deadline on these further amended Draft Regulations is now 14 November 2019.
Theses draft regulations reflect most of the changes to the amended Drug Administration Law, which will take effect on 1 December 2019, including the marketing authorisation holder system, automatic approval for clinical trials, compassionate use of drugs, conditional marketing approval and the abolition of GMP and GSP certificates.
In addition, the draft regulations also bring in some new changes that may be relevant to intellectual property, which are summarised in our e-alert.