The Food and Drug Administration of China (CFDA) recently published the draft of Regulations on Promoting Innovation of Drug and Medical Devices and Protecting Rights of the Innovators, to solicit public comments.
The draft includes some important information:
- The applicant for a drug registration should submit a declaration of non-infringement to the relevant patent rights and notify the corresponding patentees within 20 days. If the patentee thinks the drug registration is infringing his patent right, he should bring a lawsuit and inform the CFDA within 20 days after notification.
- The applicant for a drug registration can file a request for data protection for the submitted experimental data in the application. A protection term of 1.5 to 10 years can be granted based on the type of drugs.
Shortened data protection application periods will apply, if the application in China is filed later than one year after the drug has obtained approval by the European, the United States or Japanese authorities, but the protection term will be no less than 1.5 years.
Any comment on the draft should be submitted by June 11 to the CFDA at email@example.com.