Revised Draft Working Procedures for Conditional Marketing Approval of Drugs Released by NMPA

Revised draft working procedures for the review and approval of applications for conditional marketing approvals of drugs have been issued in China. On 8 July 2025, the National Medical Products Administration (NMPA) released the “Working Procedures for the Review and Approval of Applications for Conditional Marketing Approval of Drugs (Trial) (Revised Draft for Comments) along with a detailed policy interpretation.

This marks the second round of public consultation, following the initial draft published on 25 August 2023, and builds upon the currently effective 2020 version (NMPA Announcement No. 82). The revised draft remains open for public comment until 7 August 2025. Through two rounds of revision, NMPA has signaled a clear regulatory direction: ensuring access to urgently needed therapies for critically ill patients while reinforcing life-cycle oversight of conditionally approved drugs, curbing homogeneous R&D, and prioritizing truly innovative medicines with clinical value.

Evolution of Conditional Approval Policy (2020 → 2023 → 2025)

1. Entry Criteria and Application Thresholds

• 2020: Required early clinical trial data showing efficacy and potential clinical value: no requirement for confirmatory study progress.
• 2023: Added requirement that confirmatory studies must be defined as first subject enrolled.
• 2025: Further requires proof of confirmatory study initiation (defined as first subject signing informed consent), enhancing authenticity verification.

2. Post-Marketing Study Timelines and Extension

• 2020: No defined timeline, only required completion “within a specified period.”
• 2023: Introduced a 4-year limit from approval date, with one extension allowed; sales suspended during extension (except for ongoing treatments).
• 2025:
  • – Extension limit: One extension allowed in principle, with exceptions for public health emergencies.
  • – Sales suspension exception: After registration certificate expiry, sales must stop. However, drugs already in use may continue for patients in treatment or with no alternatives, subject to institutional evaluation.
  • – Certificate validity: Remains unchanged during the extension, automatic suspension expiry.

3. Procedure Conversion and Competition Management

• 2020: No provisions for conversion or same-target competition.
• 2023:
  • – First conditional approval blocks same-target conditional applications.
  • – Allows conversion to regular approval during review if confirmatory data supports.
• 2025:
  • – Generic exception: Generics may apply for conventional indications by waiving conditional ones.
  • – Dynamic competition: Products in pivotal trials may proceed but risk invalidation if a conventional approval is granted.

4. Marketing-Authorization Holder Responsibilities and Exit Mechanisms

• 2020: Required a risk management plan; no detailed exit procedures.
• 2023: Introduced voluntarily suspension upon self-assessed inefficacy: prohibited reference-standard designation before conversion.
• 2025:
  • – Prohibition on holder change: No change allowed before conversion; transferee must ensure full study transfer and feasibility.
  • – Mandatory withdrawal: Holders must suspend sales and apply for certificate cancellation if benefit cannot be confirmed.
  • – Regulatory Certificate Cancellation: Authorities may cancel certificates if studies fail or risk outweigh benefits.

Eight Key Updates and Interpretations in the 2025 Revised Draft

1. Prohibition of Holder Change

To prevent speculative behavior, the draft prohibits changes in marketing authorization holders during the conditional approval period. Transferees must demonstrate continuity and feasibility, with prior CDE consultation.

2. Enhanced Patient Access Safeguards

When sales are suspended, drugs already in circulation may continue for:

• patients already in treatment;
• critically ill patients with no alternative treatments.

This codifies “clinical irreplaceability” as an exemption, avoiding abrupt treatment discontinuation.

3. Dynamic Re-registration Mechanism

• Conditional products must convert to regular approval before re-registration.
• Conventional products with conditional indications are re-registered only for their conventional indications.

This prevents a single unconverted indication from affecting the entire product’s renewal.

4. Inclusion of Traditional Chinese Medicine (TCM)

TCM products meeting the Special Provisions for TCM Registration may apply for conditional approval with human-use experience accepted as supportive evidence - opening a pathway for innovative TCM.

5. “Dual Limits” for Confirmatory Study Protocol Revisions

• Frequency: Only one protocol amendment allowed in principle.
• Duration: Revised study timelines must not exceed the original.

This discourages repeated delays and reinforces regulatory discipline.

6. “Conditional Waiver” for Generic

Generics and biosimilar applicants may waive conditional indications and apply directly for conventional indication, accelerating access while requiring independent risk assessment.

7. Streamlined Conversion Procedure

Applicants may request conversion to regular approval during review if confirmatory studies are complete. CDE must respond within 60 working days, aiming to reduce the current average transition time of 28 months.

8. Comprehensive Cancellation Triggers

Four new triggers for certificate cancellation:

• Certificate expiry without extension;
• No conversion application after extension;
• Failed study review;
• Duration: Revised study timelines must not exceed the original.

This ensures full lifecycle accountability from approval to withdrawal.

Strategic Implications for Stakeholders

This revised draft reflects China’s commitment to balancing clinical urgency with regulatory rigor. Both domestic and international manufacturers should:

• Review pipeline candidates for conditional approval eligibility
• Prepare robust confirmatory study plans aligned with the new thresholds
• Engage early with CDE to navigate procedural transitions
• Assess generic strategy risks under the new waiver mechanism
• Ensure internal compliance systems are aligned with lifecycle oversight expectations

Further Informaiton

To read the original announcement about the draft revision of the Conditional Marketing Approval policy released by the National Medical Products Administration (NMPA), please click here.

For tailored guidance on how these changes may affect your China strategy, please contact Cisema.

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