Overview of the new Drug Regulation Registration (DRR) in China

On the 1st July 2020 the new Drug Regulation Registration (DRR) will be implemented in China. There are a number of significant changes within this new regulation covering new marketing applications, clinical trials, variations and renewals.

The update is designed to encourage innovation and generic development and improve the review process including shortening review times. A large number of technical sub documents to support the DRR are yet to be developed.

A number of key points from this new regulation are summarised below;

Clinical Trials

  • There will be no opportunity to submit new technical data if any major deficiencies are identified, the application will be rejected and would need to be resubmitted.

New marketing applications

  • Classify registration as innovative, modified or generic

  • QC testing of regulatory samples can now be initiated prior to submission rather than during review

  • Clear timelines have been assigned to each phase of the application

  • Bundling review for APIs, excipients and packaging on the registration number platform remains.

  • New designation of breakthrough therapy which once assigned allows the applicant to apply for conditional approval and priority review. This is similar to the EU PRIME designation.

Renewals

  • 5 year cycle and needs to be submitted 6 months before the licence expires

Post approval changes

  • Classification update and submission pathway for minor changes clarified

    • Major change requires approval
    • Moderate change is a notification
    • Minor change is submitted in an annual report
  • An update to the variation guideline is expected in line with this and to reflect ICH Q12.

What does this change mean?

From 1st July regulatory submissions into China will need to comply with the DRR. This will mean a review of the strategy and planning for upcoming new submissions and post approval changes to ensure they will be compliant. A new focus will need to be placed on the quality of the content of clinical trial applications to ensure approval is obtained and there are no delays to project timelines. There is also the potential to utilise new regulatory pathways to allow an earlier submission in China.

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