Asian Drug Development Market Open Up About China’s Regulatory Transformation

Researcher working with microplate in the laboratory / scientist pipetting samples in multi-well plate in the lab

China’s drug development regulatory environment going through “sea changes” and Korean drugmakers need to capitalize on the window of opportunity experts reported at recent clinical trials and China regulatory forum in Seoul, Korea.

The forum organized by Korea National Enterprise for Clinical Trials (KoNECT) and the Korea Drug Development Fund (KDDF) held a forum on global clinical development to discuss China’s deregulation and strategies for clinical development at KoNECT’s head office reports Korea Biomedical Review.

One of the largest markets in the world, China is a notoriously difficult nut to crack for foreign drug makers—a labyrinth of onerous regulations traditionally kept it difficult. But massive change is now on the way. Beijing seeks modernization and a diversified life science sector and will embrace change.

Experts at the recent Korean conference include:

Ms. Liu summarized China’s ongoing reforms in 6 points as reported by the Korea Biomedical Review:

  • Submission of new drug application (NDA) directly with data of multiregional clinical trial (MRCT) completed in the trial
  • China acceptance of overseas clinical data
  • The potential to conduct Phase I clinical trials in China while simultaneously and Phase II data outside of China unnecessary for MCRT application in China
  • No certificate of a pharmaceutical product (CPP) is required in the clinical application (CTA) and NDA in China
  • Priority approval is given to innovative drugs for rare and incurable diseases (conditional approval, review time shortened through priority review)
  • Government introduces a new review/approval system (reducing the screening period for clinical trials to 60 working days.

Ms. Liu reports foreign drugmakers can capitalize on these trends. If a foreign firm wants to release an innovative drug for a rare and intractable disease that already sells in other countries, it can receive conditional approval through fast-track review without a local trial and submit safety and efficacy data in post-marketing surveillance. Follow the link more details.