CHINA Law and Practice Contributed by: Binxin Li, Guangzhen Shang, Yue He and Lesley Wang, LeanWill Law Firm
not common, as it would lead to a regulatory compli ‑ ance issue. 2.2 Regulatory Data and Market Exclusivity Currently, the Regulations for the Implementation of the Drug Administration Law (2024) (“the Regula ‑ tions”) issued by the State Council provide general provisions for China’s drug regulatory data protection (RDP) system, although detailed implementing rules are still outstanding. In March 2025, the National Medical Products Admin ‑ istration (NMPA) issued the Draft Measures for the Implementation of Drug Regulatory Data Protection (Provisional) (Draft for Comments, not effective yet), stipulating more detailed provisions for the implemen ‑ tation of China’s RDP system. The highlights are as follows. • For innovative drugs, a six-year data protection is available from the first domestic marketing authori ‑ sation date of such drug (for innovative drugs that have already been marketed overseas, the protec ‑ tion period shall deduct the gap period between the domestic application acceptance date and the overseas marketed date). The protection scope includes all trial data used to demonstrate the drug’s safety, efficacy and quality controllability. For an innovative drug that obtains approval for multiple indications sequentially, data protection is granted separately for each indication. • For improved new drugs, a three-year data protec ‑ tion is available from the first domestic marketing authorisation date of such drug (for improved new drugs that have already been marketed overseas, the protection period shall deduct the gap period between the domestic application acceptance date and the overseas marketed date). The protection scope includes new clinical trial data proving clear clinical advantages over known active ingredient drugs. • For generic drugs, a three-year data protection is available for the first generic drug approved domestically that references an overseas-marketed but domestically unmarketed brand drug. The pro ‑ tection scope includes necessary clinical trial data supporting the approval.
During the protection period, the NMPA shall not accept any new or supplemental domestic market ‑ ing authorisation (MA) applications submitted by any other entity that relies on the protected data without authorisation. 2.3 Acceptable Pre-Launch Preparations In China, experimental use (ie, the research exemp ‑ tion) and activities covered by the Bolar exemption are acceptable pre-launch preparations for generics; see 2.1 Infringing Acts . 2.4 Publicly Available Drug and Patent Information Marketing authorisation applications (MAAs) and granted MAs are all public information available on the official websites of the NMPA and the Centre for Drug Evaluation. The China Patent Information Registration Platform for Marketed Drugs (the “Platform for Marketed Drugs”) is operated by the CDE and serves as the Chinese Orange Book. On the Platform for Marketed Drugs, the MA holder (brand drug) shall register drug and related patent information along with contact informa ‑ tion within 30 days after obtaining an MA. When submitting an MA application for a generic drug, the applicant shall make a declaration for each rel ‑ evant patent disclosed on the Platform for Marketed Drugs. Within ten working days after accepting a generic drug application, the NMPA shall publish the application information and corresponding declara ‑ tions, and the generic drug applicant shall notify the MA holder of the corresponding declarations and its supporting evidence. It is advisable for brand drugs to conduct regular monitoring of the public information of the MAAs and the corresponding patent declarations, so as to obtain related information as early as possible. 2.5 Reimbursement and Pricing/Linkage Markets Regarding participation in VBP or other centralised procurement activities (which are the main channels for reimbursement), IP infringement risk is a key issue to be addressed. In accordance with the Opinion of
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