On 10 October 2026, the Center for Drug Evaluation (CDE) published a Q&A in its "Common General Technical Questions" section, clarifying that where a generic drug applicant has made an obviously erroneous Category 1 or Category 2 patent certification, the certification may be amended under certain conditions. This is the first time since China’s drug patent linkage system took effect more than five years ago that the regulator has given an affirmative answer on whether a patent certification can be changed.

What the new guidance says

The answer has three elements. First, it reiterates that generic applicants are responsible for the truthfulness and accuracy of their certifications, and that a Category 2 certification must be supported by documents evidencing patent invalidation, a licence, or patent expiry. Second, it illustrates what counts as an "obviously erroneous certification": the originator has registered a valid patent, yet the generic applicant has filed a Category 1 or Category 2 certification. Third, it sets out a procedure: the originator may lodge an objection with the CDE; the CDE forwards the objection to the generic applicant; once the two parties reach agreement, the generic applicant may apply to amend its certification, and the CDE will open an amendment channel.

The previous position: get it right, with no route to fix it

The Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial) make generic applicants responsible for the truthfulness and accuracy of their certifications, but are silent on how a certification may be changed once made. In practice, when one company raised the question with the NMPA, it was told that there was no such requirement or procedure and that no amendment was needed. Earlier this year, the Supreme People's Court observed in a judgment that the relevant authorities should provide conditions and operational guidance for changing certification types in such situations. The CDE's answer can be read as the regulatory response to that call.

Points to note

The new channel applies only to obviously erroneous Category 1 and Category 2 certifications. It is triggered by an originator objection and conditional on agreement between the parties; it is not a mechanism that generic applicants can use unilaterally at any time. The answer also leaves open what happens if the parties cannot agree, whether the amended certification will be re-published, and whether the 45-day period for filing suit or requesting an administrative ruling will restart. These questions await further clarification.

Takeaways for generic companies

Have supporting documents ready before filing a Category 2 certification, and check carefully for timing gaps created by the 30-day window originators have to register patents after approval. If you receive an originator objection, assess it seriously: refusing to cooperate may bring no procedural advantage. Under the Supreme People's Court's reasoning, if a generic applicant refuses within a reasonable time to change its certification, or changes it to another erroneous one, the court should accept the patentee's claim and hear it on the merits.

Takeaways for originator companies

Make sure patents are registered on time and keep monitoring the generic certifications published on the platform. Where an obvious error is found, lodge an objection with the CDE, communicate directly with the generic company in parallel, and keep records of all correspondence. If negotiations fail, promptly assess whether to pursue litigation or an administrative ruling.