{"id":68396,"date":"2026-06-17T15:21:16","date_gmt":"2026-06-17T07:21:16","guid":{"rendered":"https:\/\/flcube.com\/?p=68396"},"modified":"2026-06-17T15:21:17","modified_gmt":"2026-06-17T07:21:17","slug":"chinas-cde-proposes-framework-for-reference-listed-drug-selection-following-marketing-authorization-holder-changes-for-foreign-originator-drugs-manufactured-locally","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=68396","title":{"rendered":"China’s CDE Proposes Framework for Reference Listed Drug Selection Following Marketing Authorization Holder Changes for Foreign-Originator Drugs Manufactured Locally"},"content":{"rendered":"\n

The Center for Drug Evaluation (CDE)<\/strong> of China’s National Medical Products Administration (NMPA)<\/strong> released two draft proposals establishing criteria for when drugs manufactured in China by foreign originator companies<\/strong> may retain their status as Reference Listed Drugs (RLDs)<\/strong> following a change in Marketing Authorization Holder (MAH)<\/strong>. The proposals, open for public comment for one month, aim to ensure continued access to high-quality generic drugs while maintaining regulatory consistency with international standards.<\/p>\n\n\n\n

Regulatory Proposal Overview<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Issuing Authority<\/strong><\/td>Center for Drug Evaluation (CDE), NMPA<\/td><\/tr>
Proposal Documents<\/strong><\/td>1. “Situations in Which Drugs Manufactured in China by Foreign Originator Companies May Be Selected as Reference Listed Drugs Following a Change in Marketing Authorization Holder (draft proposal)”
2. “Requirements for Reference Listed Drug Application Materials Following a Change in Marketing Authorization Holder for Drugs Manufactured in China by Foreign Originator Companies (draft proposal)”<\/td><\/tr>
Public Comment Period<\/strong><\/td>One month from publication date<\/td><\/tr>
Primary Objective<\/strong><\/td>Ensure high-quality generic drug availability through consistent RLD selection criteria<\/td><\/tr>
Regulatory Philosophy<\/strong><\/td>Originator drugs preferred as RLDs, including locally manufactured versions<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Key Eligibility Criteria for RLD Retention<\/h2>\n\n\n\n

Following a change in MAH for locally manufactured originator RLDs, the drug may retain RLD status under three specific circumstances:<\/p>\n\n\n\n

    \n
  1. Corporate Continuity:<\/strong> The MAH before and after the change belong to the same parent company<\/strong><\/li>\n\n\n\n
  2. Manufacturing Consistency:<\/strong> The drug continues to be manufactured by the original originator manufacturer<\/strong> after the MAH change<\/li>\n\n\n\n
  3. International Regulatory Alignment:<\/strong> The new MAH belongs to the same parent company as the MAH in regulatory-established major countries or regions<\/strong> (United States, Europe, or Japan)<\/li>\n<\/ol>\n\n\n\n

    Market Impact & Pharmaceutical Industry Implications<\/h2>\n\n\n\n