On May 9, the NMPA outlined new draft drug reforms. In the new draft regulation, a new drug is not described as new in China or new worldwide as previous legislation did, so it may be more challenging to interpret. This could affect other drug cycle practices and issues too. Also, in 2018, the draft outlined that new pediatric and rare disease drugs have 6 years of exclusivity. However, in the 2022 draft pediatric drugs are only receiving 12 months of market exclusivity, while orphan drugs are receiving 7 years of exclusivity, and there is no mention of new drug exclusivity. In addition, a drug sponsor change now requires CDE approval. China has been drafting and issuing new drug regulations so often over the last 5 years that even local RA experts have trouble staying on top of these changes. For more information on drug registration in China, please attend our 90-minute presentation on RAPS on August 16 at 11:00 AM: https://www.raps.org/events/china-drug-market-opening-up-for-foreign-drug-makers
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.gtlaw.com/en/insights/2022/7/china-on-the-move-proposed-pharmaceutical-regulations–reform-regulatory-landscape#:~:text=With%20the%20government%20implementing%20more,latest%20version%20of%20the%20Law.