How long does it take, in general, to obtain an authorisation from application to grant, what fees are payable and what is the normal period of validity of the authorisation?
According to the Measures for the Administration of Drug Registration, the time limit for a drug marketing authorisation review is 200 days, and in practice it might be longer. According to the Regulations on the Supervision and Administration of Medical Devices, the period for obtaining approval for medical device registration is generally within 23 days, and in practice it generally takes around three months.
Registration fees are charged separately for drug clinical trial applications and drug marketing authorisation applications. The fees are different for new drugs and chemical generic drugs.
In the case of medical device registration applications, registration fees are different for the initial registration, change of registration and renewal of registration.
Both the drug registration certificate and the medical device registration certificate are valid for five years. The holder can apply for re-registration or renewal of registration six months before expiry.
Protecting research data
What protection or exclusivities apply to the data submitted by originators to gain initial approval and, on variation or new application, to add indications or pharmaceutical forms?
China protects the undisclosed test data and other data submitted by manufacturers or distributors who have obtained licences to produce or sell drugs containing new chemical ingredients. No one can make improper commercial use of such undisclosed test data and other data. Within six years, if