NMPA Announced Draft Amendment to Implementation Regulations of PRC Drug Administration Law
ISSUING AUTHORITY:
National Medical Products Administration
DATE OF ISSUANCE:
May 9, 2022
On May 9, 2022, the National Medical Products Administration (NMPA) announced a comprehensive draft amendment (“Draft Amendment”) to the Implementation Regulations of the PRC Drug Administration Law (“DAL Implementing Regulations”). NMPA is soliciting public comments on the Draft Amendment through June 9, 2022.
The Draft Amendment provides a comprehensive regulatory framework governing the entire lifecycle management for a pharmaceutical. Highlights of the Draft Amendment are summarized below.
Firstly, the Draft Amendment provides a six-year period of exclusive rights to marketing authorization holders and prohibits unauthorized use of undisclosed clinical data and other data for regulatory filings. In addition, NMPA should not disclose such proprietary data in public unless for the interest of the public or when protective measures are in place to prevent unfair commercial use of such data.
In addition, articles 38 and 39 of the Draft Amendment mention the associated patent linkage mechanism on patent disputes during the MA application period and the 12-month market exclusivity for generic chemical drug manufacturers. These articles are identical to the provisions set out in the Patent Law (2021) and Implementing Measures for the Early Resolution Mechanism for Drug Patent Disputes (for Trial Implementation)(2021) of NMPA and CNIPA (i.e., the China National Intellectual Property Administration). Article 121 of the Draft Amendment specifies the mechanism for compulsory licenses for drug patents pursuant to Article 54 of the Patent Law (2021). The proposal is that in the event of a public health event or a national emergency, the National Health Commission can propose the commencement of compulsory licenses and suitable companies can make applications with CNIPA for a grant of compulsory license of a drug patent. Further, the MA application of the drug subject to compulsory patent license can benefit from priority review.
The Draft Amendment also outlines rules to change investigational new drug (IND) and new drug application (NDA) applicants. Specifically, the IND approval assignment must be approved by the Center for Drug Evaluation (CDE), and the CDE may issue a new clinical trial authorization (CTA) showing the new IND holder. However, the Draft Amendment does not specify the conditions and timeline for the CDE’s approval. If a company wants to assign its NDA approval to another company, the assignment must cover all formulations of the relevant drug product.
It is worth noting that the CDE currently does not review or approve the IND approval assignment. Companies can agree on the assignment by contract, and the assignee only needs to update the sponsor information on the CDE’s clinical study registry. The proposed change may raise the bar for IND approval assignment.
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