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Taiwan’s pharmaceutical approval process involves multiple regulatory bodies, and one of the most important is the Center for Drug Evaluation. Established in 1998, the CDE plays a critical role in supporting Taiwan’s drug review system by providing scientific assessments, regulatory consultation, and technical expertise during the approval process.

While the Taiwan Food and Drug Administration is the official authority responsible for approving drugs in Taiwan, the CDE acts as a key technical partner that helps streamline evaluations for new pharmaceutical products.

What Does CDE Do?

The CDE assists the TFDA by reviewing regulatory submissions for:

  • New Drug Applications (NDAs)
  • Generic drug applications
  • Biosimilars
  • Clinical trial applications
  • Product variations and post-approval changes

It evaluates critical areas such as:

  • Quality and Chemistry, Manufacturing, and Controls (CMC) documentation
  • Non-clinical study data
  • Clinical trial results
  • Safety and efficacy information
  • Risk-benefit assessments

Based on its scientific review, the CDE provides recommendations to the TFDA, which makes the final approval decision.

Regulatory Consultation Support

One of CDE’s major functions is offering consultation services to pharmaceutical companies. Sponsors can seek guidance on:

  • Clinical trial design
  • Regulatory pathways
  • Submission requirements
  • Bridging studies
  • Product development strategies

This helps companies better understand Taiwan’s regulatory expectations and avoid delays during submission.

Supporting Faster Drug Access

The CDE also helps accelerate access to innovative therapies by supporting priority reviews for critical medicines, orphan drugs, and products addressing unmet medical needs. Its scientific expertise helps ensure efficient evaluations without compromising patient safety.

Why CDE Matters for Global Pharma Companies

For foreign manufacturers entering Taiwan, understanding CDE requirements is essential for successful approval. Incomplete documentation, incorrect Regulatory strategies, or poor submission planning can lead to delays.

Working with experienced regulatory partners can help companies navigate CDE interactions, prepare compliant dossiers, and accelerate approvals.

Need Support for Taiwan Drug Registration?

FREYR supports pharmaceutical companies with Taiwan regulatory strategy, dossier preparation, submission support, lifecycle management, and market entry services.

Connect with our regulatory experts to simplify your Taiwan drug approval journey.